Last data update: Jan 27, 2025. (Total: 48650 publications since 2009)
Records 1-30 (of 38 Records) |
Query Trace: Arora M[original query] |
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Impact of metabolism-disrupting chemicals and folic acid supplementation on liver injury and steatosis in mother-child pairs
India-Aldana S , Midya V , Betanzos-Robledo L , Yao M , Alcalá C , Andra SS , Arora M , Calafat AM , Chu J , Deierlein A , Estrada-Gutierrez G , Jagani R , Just AC , Kloog I , Landero J , Oulhote Y , Walker RW , Yelamanchili S , Baccarelli AA , Wright RO , Téllez Rojo MM , Colicino E , Cantoral A , Valvi D . J Hepatol 2024 ![]() BACKGROUND AND AIMS: Scarce knowledge about the impact of metabolism-disrupting chemicals (MDCs) on steatotic liver disease limits opportunities for intervention. We evaluated pregnancy MDC-mixture associations with liver outcomes, and effect modification by folic acid (FA) supplementation in mother-child pairs. METHODS: We studied ∼200 mother-child pairs from the Mexican PROGRESS cohort, with measured 43 MDCs during pregnancy (estimated air pollutants, blood/urine metals or metalloids, urine high- and low-molecular-weight phthalate [HMWPs, LMWPs] and organophosphate-pesticide [OP] metabolites), and serum liver enzymes (ALT, AST) at ∼9 years post-parturition. Outcomes included elevated liver enzymes in children and established clinical scores for steatosis and fibrosis in mothers (i.e. , AST: ALT, FLI, HSI, FIB-4). Bayesian Weighted Quantile Sum regression assessed MDC-mixture associations with liver outcomes. We further examined chemical-chemical interactions and effect modification by self-reported FA supplementation. RESULTS: In children, many MDC-mixtures were associated with liver injury. Per quartile HMWP-mixture increase, ALT increased by 10.1% (95%CI: 1.67%, 19.4%) and AST by 5.27% (95% CI: 0.80%, 10.1%). LMWP-mixtures and air pollutant-mixtures were associated with higher AST and ALT, respectively. Air pollutant and non-essential metal/element associations with liver enzymes were attenuated by maternal cobalt blood concentrations (p-interactions<0.05). In mothers, only the LMWP-mixture was associated with odds for steatosis [OR=1.53 (95%CI: 1.01, 2.28) for HSI>36, and OR=1.62 (95%CI: 1.05, 2.49) for AST:ALT<1]. In mothers and children, most associations were attenuated (null) at FA supplementation≥600mcg/day (p-interactions<0.05). CONCLUSIONS: Pregnancy MDC exposures may increase risk for liver injury and steatosis, particularly in children. Adequate FA supplementation and maternal cobalt levels may attenuate these associations. IMPACT AND IMPLICATIONS: The effects of environmental chemical exposures on steatotic liver diseases are not well understood. In a parallel investigation of mothers and children, we found that pregnancy exposures to metabolism-disrupting chemicals may increase the risk for liver injury and steatosis, especially in the child, and that these associations could be attenuated by higher folic acid and/or cobalt levels. These findings can inform policies to decrease environmental chemical pollution and contribute to the design of clinical interventions addressing the MASLD epidemic. |
Infectious etiology of intussusception in Indian children less than 2 years old: a matched case-control analysis
Praharaj I , Reddy SN , Nair NP , Tate JE , Giri S , Thiyagarajan V , Mohan VR , Revathi R , Maheshwari K , Hemavathy P , Kumar N , Gupte MD , Arora R , Senthamizh S , Mekala S , Goru KB , Pamu P , Badur M , Pradhan S , Dash M , Mohakud NK , Ray RK , Gathwala G , Gupta M , Kanojia R , Gupta R , Goyal S , Sharma P , Mathew MA , Kochukaleekal Jacob TJ , Sundaram B , Girish Kumar CP , Dorairaj P , Pitchumani R , Maniam R , Kumaravel S , Jain H , Goswami JK , Wakhlu A , Gupta V , Liu J , Houpt ER , Parashar UD , Kang G . Gut Pathog 2024 16 (1) 61 BACKGROUND: Enteric infections are hypothesized to be associated with intussusception in children. A small increase in intussusception following rotavirus vaccination has been seen in some settings. We conducted post-marketing surveillance for intussusception following rotavirus vaccine, Rotavac introduction in India and evaluated association of intussusception with enteric pathogens. METHODS: In a case-control study nested within a large sentinel hospital-based surveillance program in India, stool samples from 272 children aged less than 2 years admitted for intussusception and 272 age-, gender- and location-matched controls were evaluated with Taqman array card based molecular assays to detect enteric viruses, bacterial enteropathogens and parasites. Matched case-control analysis with conditional logistic regression evaluated association of enteropathogens with intussusception. Population attributable fractions (PAF) were calculated for enteropathogens significantly associated with intussusception. RESULTS: The most prevalent enteropathogens in cases and controls were enteroaggregative Escherichia coli, adenovirus 40/41, adenovirus C serotypes and enteroviruses. Children with intussusception were more likely to harbor adenovirus C serotypes (adjusted odds-ratio (aOR) = 1.74; 95% confidence interval (CI) 1.06-2.87) and enteroviruses (aOR = 1.77; 95% CI 1.05-2.97) than controls. Rotavirus was not associated with increased intussusception risk. Adenovirus C (PAF = 16.9%; 95% CI 4.7% - 27.6%) and enteroviruses (PAF = 14.7%; 95% CI 4.2% - 24.1%) had the highest population attributable fraction for intussusception. CONCLUSION: Adenovirus C serotypes and enteroviruses were significantly associated with intussusception in Indian children. Rotavirus was not associated with risk of intussusception. |
Xpert MTB/RIF Ultra versus mycobacterial growth indicator tube liquid culture for detection of Mycobacterium tuberculosis in symptomatic adults: a diagnostic accuracy study
Xie YL , Eichberg C , Hapeela N , Nakabugo E , Anyango I , Arora K , Korte JE , Odero R , van Heerden J , Zemanay W , Kennedy S , Nabeta P , Hanif M , Rodrigues C , Skrahina A , Stevens W , Dietze R , Liu X , Ellner JJ , Alland D , Joloba ML , Schumacher SG , McCarthy KD , Nakiyingi L , Dorman SE . Lancet Microbe 2024 ![]() BACKGROUND: Xpert MTB/RIF Ultra (Ultra) is an automated molecular test for the detection of Mycobacterium tuberculosis in sputum. We compared the sensitivity of Ultra to that of mycobacterial growth indicator tube (MGIT) liquid culture, considered the most sensitive assay in routine clinical use. METHODS: In this prospective, multicentre, cross-sectional diagnostic accuracy study, we used a non-inferiority design to assess whether the sensitivity of a single Ultra test was non-inferior to that of a single liquid culture for detection of M tuberculosis in sputum. We enrolled adults (age ≥18 years) with pulmonary tuberculosis symptoms in 11 countries and each adult provided three sputum specimens with a minimum volume of 2 mL over 2 days. Ultra was done directly on sputum 1, and Ultra and MGIT liquid culture were done on resuspended pellet from sputum 2. Results of MGIT and solid media cultures done on sputum 3 were considered the reference standard. The pre-defined non-inferiority margin was 5·0%. FINDINGS: Between Feb 18, 2016, and Dec 4, 2019, we enrolled 2906 participants. 2600 (89%) participants were analysed, including 639 (25%) of 2600 who were positive for tuberculosis by the reference standard. Of the 2357 included in the non-inferiority analysis, 877 (37%) were HIV-positive and 984 (42%) were female. Sensitivity of Ultra performed directly on sputum 1 was non-inferior to that of sputum 2 MGIT culture (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; 95% CI -2·8 to 1·1). Sensitivity of Ultra performed on sputum 2 pellet was also non-inferior to that of sputum 2 MGIT (MGIT 91·1% vs Ultra 91·9%; difference -0·8 percentage points; -2·7 to 1·0). INTERPRETATION: For the detection of M tuberculosis in sputum from adults with respiratory symptoms, there was no difference in sensitivity of a single Ultra test to that of a single MGIT culture. Highly sensitive, rapid molecular approaches for M tuberculosis detection, combined with advances in genotypic methods for drug resistance detection, have potential to replace culture. FUNDING: US National Institute of Allergy and Infectious Diseases. |
Characteristics of decedents with COVID-19-related mortality in Kentucky, July 1-August 13, 2021
Cavanaugh AM , Raparti L , Bhurgri M , Herrington A , Holladay C , Arora V , Spicer KB , Thoroughman DA , Winter K . Public Health Rep 2023 333549231155867 OBJECTIVE: Although vaccination reduces the risk of severe COVID-19, fatal COVID-19 cases after vaccination can occur. We examined the characteristics of decedents with COVID-19-related mortality to help inform discussions about vaccination, boosters, and mitigation strategies. METHODS: We examined COVID-19-related deaths in Kentucky resulting from infections occurring from July 1 through August 13, 2021. We used records from case investigations, medical records, the Kentucky Health Information Exchange, and the Kentucky Immunization Registry to determine demographic information, vaccination status, and underlying health conditions, including calculation of the Charlson Comorbidity Index (CCI). We calculated mortality incidence rates by vaccination status by using data for unvaccinated and fully vaccinated populations in Kentucky as of July 1, 2021. RESULTS: In total, 777 COVID-19-related deaths occurred in Kentucky during the study period; 592 (76.2%) occurred among unvaccinated people. Compared with unvaccinated decedents, fully vaccinated decedents were older (median age, 77 vs 65 years; P < .001), had higher comorbidity levels (median CCI, 3 vs 1; P < .001), and were more likely to have immunocompromised health status (26.4% vs 16.0%; P = .003). Diabetes, hypertension, heart disease, and chronic lung disease were more common among vaccinated decedents than among unvaccinated decedents. Unvaccinated adults had a significantly higher risk of death than fully vaccinated adults (incidence rate ratio for age 20-49 years: 20.5 [95% CI, 6.5-64.8]; 50-64 years: 14.6 [95% CI, 9.4-22.7]; ≥65 years: 10.2 [95% CI, 8.3-12.4]). CONCLUSIONS: Immunocompromised health status, older age, and higher comorbidity were prevalent among fully vaccinated decedents, suggesting adults with these characteristics may benefit from additional protection strategies. Further understanding of the protection of additional and booster doses is needed. |
Treatment of hepatitis C in primary health care in the country of Georgia
Dolmazashvili E , Sharvadze L , Abutidze A , Chkhartishvili N , Todua M , Adamia E , Gabunia T , Shadaker S , Gvinjilia L , Arora S , Thornton K , Armstrong PA , Tsertsvadze T . Clin Liver Dis (Hoboken) 2022 20 (5) 175-178 Content available: Audio Recording. |
Lessons from the pandemic: Responding to emerging zoonotic viral diseases-a Keystone Symposia report
Cable J , Fauci A , Dowling WE , Günther S , Bente DA , Yadav PD , Madoff LC , Wang LF , Arora RK , Van Kerkhove M , Chu MC , Jaenisch T , Epstein JH , Frost SDW , Bausch DG , Hensley LE , Bergeron É , Sitaras I , Gunn MD , Geisbert TW , Muñoz-Fontela C , Krammer F , de Wit E , Nordenfelt P , Saphire EO , Gilbert SC , Corbett KS , Branco LM , Baize S , van Doremalen N , Krieger MA , Clemens SAC , Hesselink R , Hartman D . Ann N Y Acad Sci 2022 1518 (1) 209-225 The COVID-19 pandemic caught the world largely unprepared, including scientific and policy communities. On April 10-13, 2022, researchers across academia, industry, government, and nonprofit organizations met at the Keystone symposium "Lessons from the Pandemic: Responding to Emerging Zoonotic Viral Diseases" to discuss the successes and challenges of the COVID-19 pandemic and what lessons can be applied moving forward. Speakers focused on experiences not only from the COVID-19 pandemic but also from outbreaks of other pathogens, including the Ebola virus, Lassa virus, and Nipah virus. A general consensus was that investments made during the COVID-19 pandemic in infrastructure, collaborations, laboratory and manufacturing capacity, diagnostics, clinical trial networks, and regulatory enhancements-notably, in low-to-middle income countries-must be maintained and strengthened to enable quick, concerted responses to future threats, especially to zoonotic pathogens. |
Rapid diagnostic testing for response to the monkeypox outbreak - Laboratory Response Network, United States, May 17-June 30, 2022
Aden TA , Blevins P , York SW , Rager S , Balachandran D , Hutson CL , Lowe D , Mangal CN , Wolford T , Matheny A , Davidson W , Wilkins K , Cook R , Roulo RM , White MK , Berman L , Murray J , Laurance J , Francis D , Green NM , Berumen RA3rd , Gonzalez A , Evans S , Hudziec M , Noel D , Adjei M , Hovan G , Lee P , Tate L , Gose RB , Voermans R , Crew J , Adam PR , Haydel D , Lukula S , Matluk N , Shah S , Featherston J , Ware D , Pettit D , McCutchen E , Acheampong E , Buttery E , Gorzalski A , Perry M , Fowler R , Lee RB , Nickla R , Huard R , Moore A , Jones K , Johnson R , Swaney E , Jaramillo J , Reinoso Webb C , Guin B , Yost J , Atkinson A , Griffin-Thomas L , Chenette J , Gant J , Sterkel A , Ghuman HK , Lute J , Smole SC , Arora V , Demontigny CK , Bielby M , Geeter E , Newman KAM , Glazier M , Lutkemeier W , Nelson M , Martinez R , Chaitram J , Honein MA , Villanueva JM . MMWR Morb Mortal Wkly Rep 2022 71 (28) 904-907 As part of public health preparedness for infectious disease threats, CDC collaborates with other U.S. public health officials to ensure that the Laboratory Response Network (LRN) has diagnostic tools to detect Orthopoxviruses, the genus that includes Variola virus, the causative agent of smallpox. LRN is a network of state and local public health, federal, U.S. Department of Defense (DOD), veterinary, food, and environmental testing laboratories. CDC developed, and the Food and Drug Administration (FDA) granted 510(k) clearance* for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (non-variola Orthopoxvirus [NVO] assay), a polymerase chain reaction (PCR) diagnostic test to detect NVO. On May 17, 2022, CDC was contacted by the Massachusetts Department of Public Health (DPH) regarding a suspected case of monkeypox, a disease caused by the Orthopoxvirus Monkeypox virus. Specimens were collected and tested by the Massachusetts DPH public health laboratory with LRN testing capability using the NVO assay. Nationwide, 68 LRN laboratories had capacity to test approximately 8,000 NVO tests per week during June. During May 17-June 30, LRN laboratories tested 2,009 specimens from suspected monkeypox cases. Among those, 730 (36.3%) specimens from 395 patients were positive for NVO. NVO-positive specimens from 159 persons were confirmed by CDC to be monkeypox; final characterization is pending for 236. Prompt identification of persons with infection allowed rapid response to the outbreak, including isolation and treatment of patients, administration of vaccines, and other public health action. To further facilitate access to testing and increase convenience for providers and patients by using existing provider-laboratory relationships, CDC and LRN are supporting five large commercial laboratories with a national footprint (Aegis Science, LabCorp, Mayo Clinic Laboratories, Quest Diagnostics, and Sonic Healthcare) to establish NVO testing capacity of 10,000 specimens per week per laboratory. On July 6, 2022, the first commercial laboratory began accepting specimens for NVO testing based on clinician orders. |
Notes from the Field: SARS-CoV-2 Omicron Variant Infection in 10 Persons Within 90 Days of Previous SARS-CoV-2 Delta Variant Infection - Four States, October 2021-January 2022.
Roskosky M , Borah BF , DeJonge PM , Donovan CV , Blevins LZ , Lafferty AG , Pringle JC , Kelso P , Temte JL , Temte E , Barlow S , Goss M , Uzicanin A , Bateman A , Florek K , Kawakami V , Lewis J , Loughran J , Pogosjans S , Kay M , Duchin J , Lunn S , Schnitzler H , Arora S , Tate J , Ricaldi J , Kirking H . MMWR Morb Mortal Wkly Rep 2022 71 (14) 524-526 ![]() Vaccination protects against infection with SARS-CoV-2 (the virus that causes COVID-19) and related hospitalizations (1,2), and surviving a previous infection protects against B.1.1.7 (Alpha) and B.1.617.2 (Delta) variant reinfections† (2). Since the SARS-CoV-2 B.1.1.529 (Omicron) variant became predominant in the United States in late December 2021, reported reinfections have increased§ (3). Early reinfections (those occurring within 90 days of previous infection) are not well understood (4). Because some persons have prolonged detection of viral RNA after infection,¶ repeat positive nucleic acid amplification test (NAAT) results within 90 days could reflect prolonged shedding from earlier infection, presenting technical challenges to documenting and characterizing early reinfections. This report describes 10 patients from four states, with whole genome sequencing (WGS)–confirmed Omicron variant infections within 90 days of a previous Delta infection. This activity was reviewed by CDC, approved by respective institutional review boards, and was conducted consistent with applicable federal law and CDC policy.** |
COVID-19 Incidence and Death Rates Among Unvaccinated and Fully Vaccinated Adults with and Without Booster Doses During Periods of Delta and Omicron Variant Emergence - 25 U.S. Jurisdictions, April 4-December 25, 2021.
Johnson AG , Amin AB , Ali AR , Hoots B , Cadwell BL , Arora S , Avoundjian T , Awofeso AO , Barnes J , Bayoumi NS , Busen K , Chang C , Cima M , Crockett M , Cronquist A , Davidson S , Davis E , Delgadillo J , Dorabawila V , Drenzek C , Eisenstein L , Fast HE , Gent A , Hand J , Hoefer D , Holtzman C , Jara A , Jones A , Kamal-Ahmed I , Kangas S , Kanishka F , Kaur R , Khan S , King J , Kirkendall S , Klioueva A , Kocharian A , Kwon FY , Logan J , Lyons BC , Lyons S , May A , McCormick D , Mendoza E , Milroy L , O'Donnell A , Pike M , Pogosjans S , Saupe A , Sell J , Smith E , Sosin DM , Stanislawski E , Steele MK , Stephenson M , Stout A , Strand K , Tilakaratne BP , Turner K , Vest H , Warner S , Wiedeman C , Zaldivar A , Silk BJ , Scobie HM . MMWR Morb Mortal Wkly Rep 2022 71 (4) 132-138 Previous reports of COVID-19 case, hospitalization, and death rates by vaccination status() indicate that vaccine protection against infection, as well as serious COVID-19 illness for some groups, declined with the emergence of the B.1.617.2 (Delta) variant of SARS-CoV-2, the virus that causes COVID-19, and waning of vaccine-induced immunity (1-4). During August-November 2021, CDC recommended() additional primary COVID-19 vaccine doses among immunocompromised persons and booster doses among persons aged 18 years (5). The SARS-CoV-2 B.1.1.529 (Omicron) variant emerged in the United States during December 2021 (6) and by December 25 accounted for 72% of sequenced lineages (7). To assess the impact of full vaccination with additional and booster doses (booster doses),() case and death rates and incidence rate ratios (IRRs) were estimated among unvaccinated and fully vaccinated adults by receipt of booster doses during pre-Delta (April-May 2021), Delta emergence (June 2021), Delta predominance (July-November 2021), and Omicron emergence (December 2021) periods in the United States. During 2021, averaged weekly, age-standardized case IRRs among unvaccinated persons compared with fully vaccinated persons decreased from 13.9 pre-Delta to 8.7 as Delta emerged, and to 5.1 during the period of Delta predominance. During October-November, unvaccinated persons had 13.9 and 53.2 times the risks for infection and COVID-19-associated death, respectively, compared with fully vaccinated persons who received booster doses, and 4.0 and 12.7 times the risks compared with fully vaccinated persons without booster doses. When the Omicron variant emerged during December 2021, case IRRs decreased to 4.9 for fully vaccinated persons with booster doses and 2.8 for those without booster doses, relative to October-November 2021. The highest impact of booster doses against infection and death compared with full vaccination without booster doses was recorded among persons aged 50-64 and 65 years. Eligible persons should stay up to date with COVID-19 vaccinations. |
Climate Change and Human Health ECHO: Global Telementoring for Health Professionals
Katzman JG , Herring D , Schramm P , Tomedi L , Maury JM , Kalishman S , Kazhe-Dominguez B , Liu J , Martin C , Arora S . J Med Educ Curric Dev 2021 8 23821205211061019 OBJECTIVE: To increase the knowledge and communication skills of health professionals related to climate change and human health (CCHH). METHODS: From February to April 2021, Project ECHO (Extension for Community Healthcare Outcomes) created an 8-week, synchronous and virtual, CCHH ECHO telementoring series for health professionals. Didactics, simulated cases, and climate change tools were used to educate the interprofessional group of participants. RESULTS: During this CCHH ECHO pilot series, 625 unique participants represented 45 US states and 25 countries. The participants reported that they increased their knowledge, skills, and communication techniques regarding climate change and health. CONCLUSIONS: The human health effects of climate change is an emerging field, and increasing knowledge and communication skills among health practitioners is of critical importance. The CCHH ECHO is one potential platform that may reach a diverse community of health professionals globally due to the diffusion and demonopolization of knowledge. |
Building a Virtual Global Knowledge Network during COVID-19: The Infection Prevention and Control Global Webinar Series.
Wilson K , Dennison C , Struminger B , Armistad A , Osuka H , Montoya E , Padoveze MC , Arora S , Park B , Lessa FC . Clin Infect Dis 2021 73 S98-S105 INTRODUCTION: The 2019 coronavirus (COVID-19) pandemic has been an unprecedented global health challenge. Traditional modes of knowledge dissemination have not been feasible. A rapid solution was needed to share guidance and implementation examples among the global Infection Prevention and Control (IPC) community. We designed the IPC Global Webinar Series to bring together subject matter experts and IPC professionals in the fight against COVID-19. METHODS: The Extension for Community Healthcare Outcomes (ECHO) model was adapted to create an interactive global knowledge network. Speakers and panelists provided presentations and answers to questions from participants. The webinars were simultaneously interpreted to five languages and recorded for later access. RESULTS: Thirteen webinar sessions were completed from May 14 through August 6, 2020. On average, 634 participants attended each session (range: 393 - 1,181). Each session was represented by participants from an average of over 100 countries; sessions 1-3 had participation from approximate 120 countries, and sessions 6 and 12 had participation from approximately 80 countries. DISCUSSION: The IPC Global Webinar Series shared critical information and promoted peer-to-peer learning during the COVID-19 pandemic response. The webinar sessions reached a broader audience than many in-person events. The webinar series was rapidly scaled and can be rapidly re-activated as needed. Our lessons learned in designing and implementing the series can inform design of other global health virtual knowledge networks. The continued and expanded use of adapted virtual communities of practice and other learning networks for the IPC community can serve as a valuable tool for addressing COVID-19 and other infectious disease threats. |
COVID-19 Outbreak Associated with a SARS-CoV-2 R.1 Lineage Variant in a Skilled Nursing Facility After Vaccination Program - Kentucky, March 2021.
Cavanaugh AM , Fortier S , Lewis P , Arora V , Johnson M , George K , Tobias J , Lunn S , Miller T , Thoroughman D , Spicer KB . MMWR Morb Mortal Wkly Rep 2021 70 (17) 639-643 ![]() ![]() Although COVID-19 mRNA vaccines demonstrated high efficacy in clinical trials (1), they were not 100% efficacious. Thus, some infections postvaccination are expected. Limited data are available on effectiveness in skilled nursing facilities (SNFs) and against emerging variants. The Kentucky Department for Public Health (KDPH) and a local health department investigated a COVID-19 outbreak in a SNF that occurred after all residents and health care personnel (HCP) had been offered vaccination. Among 83 residents and 116 HCP, 75 (90.4%) and 61 (52.6%), respectively, received 2 vaccine doses. Twenty-six residents and 20 HCP received positive test results for SARS-CoV-2, the virus that causes COVID-19, including 18 residents and four HCP who had received their second vaccine dose >14 days before the outbreak began. An R.1 lineage variant was detected with whole genome sequencing (WGS). Although the R.1 variant has multiple spike protein mutations, vaccinated residents and HCP were 87% less likely to have symptomatic COVID-19 compared with those who were unvaccinated. Vaccination of SNF populations, including HCP, is critical to reduce the risk for SARS-CoV-2 introduction, transmission, and severe outcomes in SNFs. An ongoing focus on infection prevention and control practices is also essential. |
Rotavirus Strain Distribution before and after Introducing Rotavirus Vaccine in India.
Varghese T , Alokit Khakha S , Giri S , Nair NP , Badur M , Gathwala G , Chaudhury S , Kaushik S , Dash M , Mohakud NK , Ray RK , Mohanty P , Kumar CPG , Venkatasubramanian S , Arora R , Raghava Mohan V , Tate JE , Parashar UD , Kang G . Pathogens 2021 10 (4) ![]() ![]() In April 2016, an indigenous monovalent rotavirus vaccine (Rotavac) was introduced to the National Immunization Program in India. Hospital-based surveillance for acute gastroenteritis was conducted in five sentinel sites from 2012 to 2020 to monitor the vaccine impact on various genotypes and the reduction in rotavirus positivity at each site. Stool samples collected from children under 5 years of age hospitalized with diarrhea were tested for group A rotavirus using a commercial enzyme immunoassay, and rotavirus strains were characterized by RT-PCR. The proportion of diarrhea hospitalizations attributable to rotavirus at the five sites declined from a range of 56-29.4% in pre-vaccine years to 34-12% in post-vaccine years. G1P[8] was the predominant strain in the pre-vaccination period, and G3P[8] was the most common in the post-vaccination period. Circulating patterns varied throughout the study period, and increased proportions of mixed genotypes were detected in the post-vaccination phase. Continuous long-term surveillance is essential to understand the diversity and immuno-epidemiological effects of rotavirus vaccination. |
Risk of intussusception after monovalent rotavirus vaccine (Rotavac) in Indian infants: A self-controlled case series analysis
Das MK , Arora NK , Poluru R , Tate JE , Gupta B , Sharan A , Aggarwal MK , Haldar P , Parashar UD , Zuber PLF , Bonhoeffer J , Ray A , Wakhlu A , Vyas BR , Iqbal Bhat J , Goswami JK , Mathai J , Kameswari K , Bharadia L , Sankhe L , Ajayakumar MK , Mohan N , Jena PK , Sarangi R , Shad R , Debbarma SK , Shyamala J , Ratan SK , Sarkar S , Kumar V , Maure CG , Dubey AP , Gupta A , Sam CJ , Mufti GN , Trivedi H , Shad J , Lahiri K , R K , Luthra M , Behera N , P P , Rajamani G , Kumar R , Sarkar R , Santosh Kumar A , Sahoo SK , Ghosh SK , Mane S , Dash A , Charoo BA , Tripathy BB , Rajendra Prasad G , S HK , K J , Sarkar NR , Arunachalam P , Mohapatra SSG , Garge S . Vaccine 2021 39 (1) 78-84 BACKGROUND: An association between rotavirus vaccination and intussusception has been documented in post-licensure studies in some countries. We evaluated the risk of intussusception associated with monovalent rotavirus vaccine (Rotavac) administered at 6, 10 and 14 weeks of age in India. METHODS: Active prospective surveillance for intussusception was conducted at 22 hospitals across 16 states from April 2016 through September 2017. Data on demography, clinical features and vaccination were documented. Age-adjusted relative incidence for 1-7, 8-21, and 1-21 days after rotavirus vaccination in children aged 28-364 days at intussusception onset was estimated using the self-controlled case-series (SCCS) method. Only Brighton Collaboration level 1 cases were included. RESULTS: Out of 670 children aged 2-23 months with intussusception, 311 (46.4%) children were aged 28-364 days with confirmed vaccination status. Out of these, 52 intussusception cases with confirmed receipt of RVV were included in the SCCS analysis. No intussusception case was observed within 21 days of dose 1. Only one case occurred during 8-21 days after the dose 2. Post-dose 3, two cases in 1-7 days and 7 cases during 8-21 days period were observed. There was no increased risk of intussusception during 1-7 days after the doses 1 and 2 (zero cases observed) or dose 3 (relative incidence [RI], 1.71 [95% confidence interval {CI} 0.0-5.11]). Similarly, no increased risk during 8-21 days after the dose 1 (zero cases observed), dose 2 (RI, 0.71 [95% CI, 0.0-3.28]) or dose 3 (RI, 2.52 [95% CI, 0.78-5.61]). The results were similar for 1-21 day periods after the doses separately or pooled. CONCLUSIONS: The risk of intussusception during the first 21 days after any dose of rotavirus vaccine (Rotavac) was not higher among the Indian infants than the background risk, based on limited SCCS analysis of 52 children. |
Intussusception after rotavirus vaccine introduction in India
Reddy SN , Nair NP , Tate JE , Thiyagarajan V , Giri S , Praharaj I , Mohan VR , Babji S , Gupte MD , Arora R , Bidari S , Senthamizh S , Mekala S , Goru KB , Reddy B , Pamu P , Gorthi RP , Badur M , Mohan V , Sathpathy S , Mohanty H , Dash M , Mohakud NK , Ray RK , Mohanty P , Gathwala G , Chawla S , Gupta M , Gupta R , Goyal S , Sharma P , Mathew MA , Jacob TJK , Sundaram B , Purushothaman GKC , Dorairaj P , Jagannatham M , Murugiah K , Boopathy H , Maniam R , Gurusamy R , Kumaravel S , Shenoy A , Jain H , Goswami JK , Wakhlu A , Gupta V , Vinayagamurthy G , Parashar UD , Kang G . N Engl J Med 2020 383 (20) 1932-1940 BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.). |
Implementation and evaluation of a Project ECHO telementoring program for the Namibian HIV workforce
Bikinesi L , O'Bryan G , Roscoe C , Mekonen T , Shoopala N , Mengistu AT , Sawadogo S , Agolory S , Mutandi G , Garises V , Pati R , Tison L , Igboh L , Johnson C , Rodriguez EM , Ellerbrock T , Menzies H , Baughman AL , Brandt L , Forster N , Scott J , Wood B , Unruh KT , Arora S , Iandiorio M , Kalishman S , Zalud-Cerrato S , Lehmer J , Lee S , Mahdi MA , Spedoske S , Zuber A , Reilley B , Ramers CB , Hamunime N , O'Malley G , Struminger B . Hum Resour Health 2020 18 (1) 61 BACKGROUND: The Namibian Ministry of Health and Social Services (MoHSS) piloted the first HIV Project ECHO (Extension for Community Health Outcomes) in Africa at 10 clinical sites between 2015 and 2016. Goals of Project ECHO implementation included strengthening clinical capacity, improving professional satisfaction, and reducing isolation while addressing HIV service challenges during decentralization of antiretroviral therapy. METHODS: MoHSS conducted a mixed-methods evaluation to assess the pilot. Methods included pre/post program assessments of healthcare worker knowledge, self-efficacy, and professional satisfaction; assessment of continuing professional development (CPD) credit acquisition; and focus group discussions and in-depth interviews. Analysis compared the differences between pre/post scores descriptively. Qualitative transcripts were analyzed to extract themes and representative quotes. RESULTS: Knowledge of clinical HIV improved 17.8% overall (95% confidence interval 12.2-23.5%) and 22.3% (95% confidence interval 13.2-31.5%) for nurses. Professional satisfaction increased 30 percentage points. Most participants experienced reduced professional isolation (66%) and improved CPD credit access (57%). Qualitative findings reinforced quantitative results. Following the pilot, the Namibia MoHSS Project ECHO expanded to over 40 clinical sites by May 2019 serving more than 140 000 people living with HIV. CONCLUSIONS: Similar to other Project ECHO evaluation results in the United States of America, Namibia's Project ECHO led to the development of ongoing virtual communities of practice. The evaluation demonstrated the ability of the Namibia HIV Project ECHO to improve healthcare worker knowledge and satisfaction and decrease professional isolation. |
Global vaccine action plan lessons learned I: Recommendations for the next decade
MacDonald N , Mohsni E , Al-Mazrou Y , Kim Andrus J , Arora N , Elden S , Madrid MY , Martin R , Mahmoud Mustafa A , Rees H , Salisbury D , Zhao Q , Jones I , Steffen CA , Hombach J , O'Brien KL , Cravioto A . Vaccine 2020 38 (33) 5364-5371 The Global Vaccine Action Plan 2011-2020 (GVAP) was developed to realize the ambitions of the Decade of Vaccines - that all individuals and communities enjoy lives free from vaccine-preventable diseases. It included a comprehensive monitoring and evaluation/accountability framework to assess progress towards global targets with recommendations for corrective actions. While many of the GVAP targets are very unlikely to be met by the end of 2020, substantial progress has nevertheless been made, establishing a strong foundation for a successor global immunization strategy, the Immunization Agenda 2030 (IA2030). The Strategic Advisory Group of Experts on immunization has made a series of recommendations to ensure that the lessons learned from GVAP inform the development and implementation of IA2030. |
The science of vaccine safety: Summary of meeting at Wellcome Trust
Plotkin SA , Offit PA , DeStefano F , Larson HJ , Arora NK , Zuber PLF , Fombonne E , Sejvar J , Lambert PH , Hviid A , Halsey N , Garcon N , Peden K , Pollard AJ , Markowitz LE , Glanz J . Vaccine 2020 38 (8) 1869-1880 Vaccines are everywhere hugely successful but are also under attack. The reason for the latter is the perception by some people that vaccines are unsafe. However that may be, vaccine safety, life any other scientific subject, must be constantly studied. It was from this point of view that a meeting was organized at the Wellcome Trust in London in May 2019 to assess some aspects of vaccine safety as subjects for scientific study. The objective of the meeting was to assess what is known beyond reasonable doubt and conversely what areas need additional studies. Although the meeting could not cover all aspects of vaccine safety science, many of the most important issues were addressed by a group of about 30 experts to determine what is already known and what additional studies are merited to assess the safety of the vaccines currently in use. The meeting began with reviews of the current situation in different parts of the world, followed by reviews of specific controversial areas, including the incidence of certain conditions after vaccination and the safety of certain vaccine components. Lastly, information about the human papillomavirus vaccine was considered because its safety has been particularly challenged by vaccine opponents. The following is a summary of the meeting findings. In addition to this summary, the meeting organizers will explore opportunities to perform studies that would enlarge knowledge of vaccine safety. |
Lessons on causality assessment and communications from the 2019 South-East Asia Regional (SEAR) workshop on inter-country expert review of selected Adverse Events Following Immunization (AEFI) cases
MacDonald NE , Guichard S , Arora N , Menning L , Wilhelm E . Vaccine 2019 38 (32) 4924-4932 BACKGROUND: Surveillance of AEFI is fundamental for improving safety and maintaining public support for vaccination. In SEAR, billions of doses of vaccine are given annually. The objective of the 2019 SEAR AEFI training workshop was to further strengthen in-country vaccine safety, assess capacity compared to 2014 and to better integrate communication into the AEFI causality assessment program. METHODS: A 3 (1/2) day workshop with AEFI experts from all 11 SEAR countries. Participants outlined each county's AEFI data, critiqued their AEFI program, reviewed and critiqued causality assessment of 23 anonymized serious AEFI cases and proposed communication plans for each. RESULTS: Between 2016 and 2018, over 2.9 billion doses of vaccine were given in SEAR. Compared to 2014, AEFI detection and causality assessment skills had improved. AEFI experts' communication planning skills markedly improved during the workshop. Good concordance was found between country causality assessment findings and the workshop critiques. A list of targeted recommendations (country, regional and global levels) arose from the workshop. CONCLUSIONS: SEAR countries have much improved their AEFI detection and causality assessment expertise since 2014. Given the high volume of doses administered and the AEFI technical expertise, SEAR countries can well monitor safety of regionally produced vaccines. Integration of AEFI communication into AEFI causality assessment can help mitigate potential negative impacts of serious AEFIs. |
Three years of progress towards achieving hepatitis C elimination in the country of Georgia, April 2015 - March 2018
Tsertsvadze T , Gamkrelidze A , Chkhartishvili N , Abutidze A , Sharvadze L , Kerashvili V , Butsashvili M , Metreveli D , Gvinjilia L , Shadaker S , Nasrullah M , Adamia E , Zeuzem S , Afdhal N , Arora S , Thornton K , Skaggs B , Kuchuloria T , Lagvilava M , Sergeenko D , Averhoff F . Clin Infect Dis 2019 71 (5) 1263-1268 BACKGROUND: In April 2015, in collaboration with U.S. CDC and Gilead Sciences, Georgia embarked on the world's first hepatitis C elimination program. We aimed to assess progress towards elimination targets after three years since the beginning of the elimination program. METHODS: We constructed an HCV care cascade for adults in Georgia, based on the estimated 150,000 persons age >/= 18 years with active HCV infection. All patients who were screened or entered the treatment program during April 2015 - March 2018 were included in the analysis. Data on the number of persons screened for HCV was extracted from the national HCV screening database. For treatment component we utilized data from the Georgia National HCV treatment program database. Available treatment options included sofosbuvir (SOF) and ledipasvir/sofosbuvir (LDV/SOF) based regimens. RESULTS: Since April 2015, a cumulative 974,817 adults were screened for HCV antibodies, 86,624 persons tested positive, of which 61,925 underwent HCV confirmatory testing. Among estimated 150,000 adults living with chronic hepatitis C in Georgia, 52,856 (35.1%) were diagnosed, 45,334 (30.2%) initiated treatment with DAA, and 29,090 (19.4%) achieved sustained virologic response (SVR). Overall 37,256 persons were eligible for SVR assessment, of these only 29,620 (79.5%) returned for evaluation. In the per-protocol analysis, SVR rate achieved was 98.2% (29,090/29,620), and 78.1% (29,090/37,256) in the intent-to-treat analysis. CONCLUSIONS: Georgia has made substantial progress in the path towards eliminating hepatitis C. Scaling-up testing and diagnosis, along with effective linkage to treatment services are needed to achieve the goal of elimination. |
Rotavirus vaccine impact assessment surveillance in India: protocol and methods
Nair NP , Reddy NS , Giri S , Mohan VR , Parashar U , Tate J , Shah MP , Arora R , Gupte M , Mehendale SM , Kang G . BMJ Open 2019 9 (4) e024840 INTRODUCTION: Rotavirus infection accounts for 39% of under-five diarrhoeal deaths globally and 22% of these deaths occur in India. Introduction of rotavirus vaccine in a national immunisation programme is considered to be the most effective intervention in preventing severe rotavirus disease. In 2016, India introduced an indigenous rotavirus vaccine (Rotavac) into the Universal Immunisation Programme in a phased manner. This paper describes the protocol for surveillance to monitor the performance of rotavirus vaccine following its introduction into the routine childhood immunisation programme. METHODS: An active surveillance system was established to identify acute gastroenteritis cases among children less than 5 years of age. For all children enrolled at sentinel sites, case reporting forms are completed and a copy of vaccination record and a stool specimen obtained. The forms and specimens are sent to the referral laboratory for data entry, analysis, testing and storage. Data from sentinel sites in states that have introduced rotavirus vaccine into their routine immunisation schedule will be used to determine rotavirus vaccine impact and effectiveness. ETHICS AND DISSEMINATION: The Institutional Review Board of Christian Medical College, Vellore, and all the site institutional ethics committees approved the project. Results will be disseminated in peer-reviewed journals and with stakeholders of the universal immunisation programme in India. |
Long-term survivorship care after cancer treatment - summary of a 2017 National Cancer Policy Forum Workshop
Kline RM , Arora NK , Bradley CJ , Brauer ER , Graves DL , Lunsford NB , McCabe MS , Nasso SF , Nekhlyudov L , Rowland JH , Schear RM , Ganz PA . J Natl Cancer Inst 2018 110 (12) 1300-1310 The National Cancer Policy Forum of the National Academies of Sciences, Engineering and Medicine sponsored a workshop on July 24 and 25, 2017 on Long-Term Survivorship after Cancer Treatment. The workshop brought together diverse stakeholders (patients, advocates, academicians, clinicians, research funders, and policymakers) to review progress and ongoing challenges since the Institute of Medicine (IOM)'s seminal report on the subject of adult cancer survivors published in 2006. This commentary profiles the content of the meeting sessions and concludes with recommendations that stem from the workshop discussions. Although there has been progress over the past decade, many of the recommendations from the 2006 report have not been fully implemented. Obstacles related to the routine delivery of standardized physical and psychosocial care services to cancer survivors are substantial, with important gaps in care for patients and caregivers. Innovative care models for cancer survivors have emerged, and changes in accreditation requirements such as the Commission on Cancer's (CoC) requirement for survivorship care planning have put cancer survivorship on the radar. The Center for Medicare & Medicaid Innovation's Oncology Care Model (OCM), which requires psychosocial services and the creation of survivorship care plans for its beneficiary participants, has placed increased emphasis on this service. The OCM, in conjunction with the CoC requirement, is encouraging electronic health record vendors to incorporate survivorship care planning functionality into updated versions of their products. As new models of care emerge, coordination and communication among survivors and their clinicians will be required to implement patient- and community-centered strategies. |
Safety monitoring of ROTAVAC vaccine and etiological investigation of intussusception in India: study protocol
Reddy S , Nair NP , Giri S , Mohan VR , Tate JE , Parashar UD , Gupte MD , Arora R , Kang G . BMC Public Health 2018 18 (1) 898 BACKGROUND: ROTAVAC, an indigenous rotavirus vaccine, was introduced in the universal immunization program of India in four states in 2016 and expanded to five more states in 2017. The clinical trial on efficacy of ROTAVAC did not detect an increased risk of intussusception, but the trial was not large enough to detect a small risk. This protocol paper describes the establishment and implementation of a surveillance system to monitor the safety of rotavirus vaccine and investigate the potential infectious etiologies of intussusception. METHODS: This is a multi-centric hospital-based active surveillance being conducted at 28 hospitals in nine states of India. Data gathered from surveillance will be used to assess the risk of intussusception after ROTAVAC administration and to determine the infectious etiologies of intussusception. For safety assessment of ROTAVAC vaccine, children aged less than two years with intussusception admitted at the sentinel hospitals are enrolled into surveillance, a case report form completed, and a copy of the vaccination card obtained. The risk of intussusception following rotavirus vaccination will be assessed using a self-controlled case-series design. The investigation for potential infectious etiologies of intussusception is through a matched case-control design. Children enrolled for the safety assessment serve as cases and for each case, an age, gender and location matched control is enrolled within 30 days of case enrollment. Stool specimens are obtained from cases and controls. All forms and specimens are sent to the referral laboratory for data entry, analysis, multiplexed molecular testing, and storage. DISCUSSION: Anticipated public health benefits of this surveillance include the generation of information useful to national government on safety of vaccine and to make future decisions on vaccine use through risk-benefit analysis. Investigating infectious agents may help to determine the potential infectious etiologies of intussusception. |
Building virtual communities of practice for health
Struminger B , Arora S , Zalud-Cerrato S , Lowrance D , Ellerbrock T . Lancet 2017 390 (10095) 632-634 Advances in medical research and innovation mean little if they do not reach the patients who need them. Too often, specialised medical knowledge remains within the walls of academic and tertiary care centres in capitals and major cities, inaccessible to much of the world’s population due to geographical distance and economic disparity. To “ensure healthy lives and promote well-being for all at all ages”, UN Sustainable Development Goal 3, a more efficient and equitable way to disseminate new scientific knowledge and evidence-based expertise is needed. | During the past two decades, technology-enhanced communication and collaborative learning initiatives have converged to produce innovative and powerful learning platforms. The rise of Internet-based communication has spurred a revolution in online education and knowledge sharing, from massive open online courses (MOOCs), such as Coursera, to online learning platforms (eg, Khan Academy) and continuing education resources (eg, the University of Washington’s HIV Web Study). Collaborative learning in health care has evolved rapidly; the Institute for Healthcare Improvement’s collaborative learning model offers one leading example.1 Telemedicine also allows long-distance training for health-care professionals,2 an effective method to deliver patient-centred, contextual medical curricula,3 and supportive supervision. Additionally, online social networking enables communities of practice4 that “offer the potential to bring together temporally and geographically dispersed actors to work towards a common purpose”.5 Through technology, communities of practice are being implemented across health-care areas, such as integrated care,6 pain management,7 health visiting services,8 and nurse education.9 These virtual communities enable collaborative learning that transcends geography.10 |
The influence of "westernization" on nutrition and physical activity behaviors of adolescents in New Delhi, India: are we exporting an epidemic of obesity?
Harrell M , Ussery E , Greene-Cramer B , Ranjit N , Sharma SV , Arora M . J Appl Res Child 2015 6 (2) Purpose. To examine the relationships between “westernization” and nutrition and physical activity behaviors among older adolescents in Delhi, India. These relations have not been explored, despite increasingly strong and pervasive socio-cultural influences from the West. | Methods. Students (n=1818) in 8th and 10th grades in 4 Private (higher SES) and 4 Government (lower SES) schools in Delhi, India participated in a cross-sectional study. Height and weight were measured to determine weight status. Information on “westernization” and nutrition, physical activity, sedentary, and dieting behaviors was collected in a survey. The measure of “westernization” assessed 4 domains of culture on a bi-dimensional scale that focused on these young people’s identification with Indian (α=0.86) and Western (α=0.81) ways of living. Mixed-effects regression models were used to investigate the association between “westernization,” weight status, and health behaviors. Gender, school type (SES), and grade were evaluated as effect modifiers. Results. “Westernization” was not directly associated with weight status or BMI (p>0.500). However, adolescents’ identification with Western ways of living was consistently related to both unhealthy (e.g., fast food consumption, pppConclusions. The influence of “westernization” on nutrition and physical activity behaviors of older adolescents in Delhi, India is complex and not wholly negative, as might be hypothesized. |
Gene integrated set profile analysis: a context-based approach for inferring biological endpoints.
Kowalski J , Dwivedi B , Newman S , Switchenko JM , Pauly R , Gutman DA , Arora J , Gandhi K , Ainslie K , Doho G , Qin Z , Moreno CS , Rossi MR , Vertino PM , Lonial S , Bernal-Mizrachi L , Boise LH . Nucleic Acids Res 2016 44 (7) e69 ![]() The identification of genes with specific patterns of change (e.g. down-regulated and methylated) as phenotype drivers or samples with similar profiles for a given gene set as drivers of clinical outcome, requires the integration of several genomic data types for which an 'integrate by intersection' (IBI) approach is often applied. In this approach, results from separate analyses of each data type are intersected, which has the limitation of a smaller intersection with more data types. We introduce a new method, GISPA (Gene Integrated Set Profile Analysis) for integrated genomic analysis and its variation, SISPA (Sample Integrated Set Profile Analysis) for defining respective genes and samples with the context of similar, a priori specified molecular profiles. With GISPA, the user defines a molecular profile that is compared among several classes and obtains ranked gene sets that satisfy the profile as drivers of each class. With SISPA, the user defines a gene set that satisfies a profile and obtains sample groups of profile activity. Our results from applying GISPA to human multiple myeloma (MM) cell lines contained genes of known profiles and importance, along with several novel targets, and their further SISPA application to MM coMMpass trial data showed clinical relevance. |
Rotavirus vaccines at the threshold of implementation in India
Tate JE , Arora R , Kang G , Parashar UD . Natl Med J India 2014 27 (5) 245-8 India is poised to introduce rotavirus vaccines into its routine childhood immunization programme. Substantial data ara available on disease and economic burden of rotavirus gastroenteritis and on circulating strains in India, which highlight the public health need for a rotavirus vaccine. A locally manufactured oral rotavirus vaccine has been licensed in India and it has been shown to be effective against severe rotavirus gastroenteritis in Indian children. The Government of India has announced that the vaccine will be included in the universal immunization n programme. Careful planning and preparation for post-licensure impact and safety evaluations will ensure that additional high quality benefit-risk data will be available for India. |
Insights from global data for use of rotavirus vaccines in India
Rao TS , Arora R , Khera A , Tate JE , Parashar U , Kang G . Vaccine 2014 32S1 A171-A178 Rotavirus vaccines are being introduced in several low- and middle-income countries across the world with and without support from the GAVI Alliance. India has the highest disease burden of rotavirus based on morbidity and mortality estimates and several indigenous vaccine manufacturers are developing rotavirus vaccines. One candidate has undergone phase III testing and others have completed evaluation in phase II. Global data on licensed vaccine performance in terms of impact on disease, strain diversity, safety and cost-effectiveness has been reviewed to provide a framework for decision making in India. |
Rotavirus disease and vaccines in India: A tremendous public health opportunity
Tate JE , Arora R , Bhan MK , Yewale V , Parashar UD , Kang G . Vaccine 2014 32 Suppl 1 vii-xii In March 2014, The Lancet reported the successful results of the efficacy and safety trial of 116E, the first Indian-manufactured rotavirus vaccine to complete phase 3 clinical testing [1]. In a multicenter study conducted in three geographically and culturally diverse cities of India – Delhi, Pune, and Vellore – despite intensive health care provision which may have modified the severity of disease, the 116E vaccine showed efficacy comparable to that of two internationally licensed rotavirus vaccines manufactured by Merck and Co. and GlaxoSmithKline. Several other indigenously manufactured rotavirus vaccines are in development in India, some of which are in late stages of clinical testing. With an effective, indigenously produced rotavirus vaccine on the near-term horizon, India, which singularly accounts for almost one fifth of the world's burden of rotavirus deaths in children [2], is poised to have a new tool in the arsenal of interventions to reduced morbidity and mortality from childhood diarrhea. To help assess the public health value of the vaccine, understanding the current rotavirus disease burden and epidemiology, circulating strains, and economic burden of rotavirus in India is important. This supplement contains papers summarizing the most up-to-date data on these issues. In addition, the supplement addresses areas relevant for post-introduction monitoring of rotavirus vaccine, including potential safety concerns associated with other rotavirus vaccines such as intussusception, a condition in which one portion of the bowel telescopes into another causing a blockage. Finally, this supplement contains papers looking at the performance of rotavirus vaccines, both the indigenous and internationally available vaccines, in India and explores strategies to improve vaccine performance. This collection of papers will help provide a complete picture of rotavirus disease in India and the potential for a rotavirus vaccination program, and also set the platform to assess the impact of vaccines post-introduction. |
Diversity of circulating rotavirus strains in children hospitalized with diarrhea in India, 2005-2009
Kang G , Desai R , Arora R , Chitamabar S , Naik TN , Krishnan T , Deshpande J , Gupte MD , Venkatasubramaniam S , Gentsch JR , Parashar UD . Vaccine 2013 31 (27) 2879-2883 ![]() BACKGROUND: India accounts for 22% of the 453,000 global rotavirus deaths among children <5 years annually. The Indian Rotavirus Strain Surveillance Network provides clinicians and public health partners with valuable rotavirus disease surveillance data. Our analysis offers policy-makers an update on rotavirus disease burden with emphasis on regional shifts in rotavirus strain epidemiology in India. METHODS: Children <5 years requiring hospitalization for acute gastroenteritis were selected from 10 representative hospitals in 7 cities throughout India between November 2005 through June 2009. We used a modified World Health Organization protocol for rotavirus surveillance; stool specimens were collected and tested for rotavirus using enzyme immunoassay and reverse-transcription polymerase chain reaction. RESULTS: A total of 7285 stool specimens collected were tested for rotavirus, among which 2899 (40%) were positive for rotavirus. Among the 2899 rotavirus detections, a G-type could not be determined for 662 (23%) and more than one G type was detected in 240 (8%). Of 1997 (69%) patients with only one G-type, the common types were G1 (25%), G2 (21%), G9 (13%), and G12 (10%). The proportion of rotavirus infections attributed to G12 infections rose from 8% to 39% in the Northern region and from 8% to 24% in the Western region. CONCLUSIONS: This study highlights the large, ongoing burden of rotavirus disease in India, as well as interesting regional shifts in rotavirus strain epidemiology, including an increasing detection of G12 rotavirus strains in some regions. While broad heterotypic protection from rotavirus vaccination is expected based on pre- and post-licensure data from other settings, effectiveness assessments and rotavirus strain monitoring after vaccine introduction will be important. |
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