Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Query Trace: Sisay Z[original query] |
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Head-to-head comparison of the immunogenicity of RotaTeq and Rotarix rotavirus vaccines and factors associated with seroresponse in infants in Bangladesh: a randomised, controlled, open-label, parallel, phase 4 trial
Velasquez-Portocarrero DE , Wang X , Cortese MM , Snider CJ , Anand A , Costantini VP , Yunus M , Aziz AB , Haque W , Parashar U , Sisay Z , Soeters HM , Hyde TB , Jiang B , Zaman K . Lancet Infect Dis 2022 22 (11) 1606-1616 BACKGROUND: A head-to-head comparison of the most widely used oral rotavirus vaccines has not previously been done, particularly in a high child mortality setting. We therefore aimed to compare the immunogenicity of RotaTeq (Merck, Kenilworth, NJ, USA) and Rotarix (GlaxoSmithKline, Rixensart, Belgium) rotavirus vaccines in the same population and examined risk factors for low seroresponse. METHODS: We did a randomised, controlled, open-label, parallel, phase 4 trial in urban slums within Mirpur and Mohakahli (Dhaka, Bangladesh). We enrolled eligible participants who were healthy infants aged 6 weeks and full-term (ie, >37 weeks' gestation). We randomly assigned participants (1:1), using block randomisation via a computer-generated electronic allocation with block sizes of 8, 16, 24, and 32, to receive either three RotaTeq vaccine doses at ages 6, 10, and 14 weeks or two Rotarix doses at ages 6 and 10 weeks without oral poliovirus vaccine. Coprimary outcomes were the rotavirus-specific IgA seroconversion in both vaccines, and the comparison of the rotavirus IgA seroconversion by salivary secretor phenotype in each vaccine arm. Seroconversion at age 18 weeks in the RotaTeq arm and age of 14 weeks in the Rotarix arm was used to compare the complete series of each vaccine. Seroconversion at age 14 weeks was used to compare two RotaTeq doses versus two Rotarix doses. Seroconversion at age 22 weeks was used to compare the immunogenicity at the same age after receiving the full vaccine series. Safety was assessed for the duration of study participation. This study is registered with ClinicalTrials.gov, NCT02847026. FINDINGS: Between Sept 1 and Dec 8, 2016, a total of 1144 infants were randomly assigned to either the RotaTeq arm (n=571) or Rotarix arm (n=573); 1080 infants (531 in the RotaTeq arm and 549 in the Rotarix arm) completed the study. Rotavirus IgA seroconversion 4 weeks after the full series occurred in 390 (73%) of 531 infants age 18 weeks in the RotaTeq arm and 354 (64%) of 549 infants age 14 weeks in the Rotarix arm (p=0·01). At age 14 weeks, 4 weeks after two doses, RotaTeq recipients had lower seroconversion than Rotarix recipients (268 [50%] of 531 vs 354 [64%] of 549; p<0·0001). However, at age 22 weeks, RotaTeq recipients had higher seroconversion than Rotarix recipients (394 [74%] of 531 vs 278 [51%] of 549; p<0·0001). Among RotaTeq recipients, seroconversion 4 weeks after the third dose was higher than after the second dose (390 [73%] of 531 vs 268 [50%] of 531; p<0·0001]. In the RotaTeq arm, rotavirus IgA seroconversion was lower in non-secretors than in secretors at ages 14 weeks (p=0·08), 18 weeks (p=0·01), and 22 weeks (p=0·02). Similarly, in the Rotarix arm, rotavirus IgA seroconversion was lower in non-secretors than in secretors at ages 14 weeks (p=0·02) and 22 weeks (p=0·01). 65 (11%) of 571 infants had adverse events in the RotaTeq arm compared with 63 (11%) of 573 infants in the Rotarix arm; no adverse events were attributed to the use of either vaccine. One death due to aspiration occurred in the RotaTeq arm, which was not related to the vaccine. INTERPRETATION: RotaTeq induced a higher magnitude and longer duration of rotavirus IgA response than Rotarix in this high child mortality setting. Additional vaccination strategies should be evaluated to overcome the suboptimal performance of current oral rotavirus vaccines in these settings. FUNDING: US Centers for Disease Control and Prevention. |
The effect of long-lasting insecticidal nets (LLINs) physical integrity on utilization
Hiruy HN , Zewde A , Irish SR , Abdelmenan S , Woyessa A , Wuletaw Y , Solomon H , Haile M , Sisay A , Chibsa S , Worku A , Yukich J , Berhane Y , Keating J . Malar J 2021 20 (1) 468 BACKGROUND: In Ethiopia, despite improvements in coverage and access, utilization of long-lasting insecticidal nets (LLINs) remains a challenge. Different household-level factors have been identified as associated with LLIN use. However, the contribution of LLIN physical integrity to their utilization is not well investigated and documented. This study aimed to assess the association between the physical integrity of LLINs and their use. METHODS: This study employed a nested case-control design using secondary data from the Ethiopian LLIN durability monitoring study conducted from May 2015 to June 2018. LLINs not used the night before the survey were identified as cases, while those used the previous night were categorized as controls. The physical integrity of LLINs was classified as no holes, good, acceptable, and torn using the proportionate hole index (pHI). A Generalized Estimating Equation (GEE) model was used to assess and quantify the association between LLIN physical integrity and use. The model specifications included binomial probabilistic distribution, logit link, exchangeable correlation matrix structure, and robust standard errors. The factors included in the model were selected first by fitting binary regression, and then by including all factors that showed statistical significance at P-value less than 0.25 and conceptually relevant variables into the multivariate regression model. RESULTS: A total of 5277 observations fulfilled the inclusion criteria. Out of these 1767 observations were cases while the remaining 3510 were controls. LLINs that were in torn physical condition had higher odds (AOR [95% CI] = 1.76 [1.41, 2.19]) of not being used compared to LLINs with no holes. Other factors that showed significant association included the age of the LLIN, sleeping place type, washing status of LLINs, perceptions towards net care and repair, LLIN to people ratio, economic status, and study site. CONCLUSION AND RECOMMENDATION: LLINs that have some level of physical damage have a relatively higher likelihood of not being used. Community members need to be educated about proper care and prevention of LLIN damage to delay the development of holes as long as possible and use available LLINs regularly. |
The haematological consequences of Plasmodium vivax malaria after chloroquine treatment with and without primaquine: a WorldWide Antimalarial Resistance Network systematic review and individual patient data meta-analysis.
Commons RJ , Simpson JA , Thriemer K , Chu CS , Douglas NM , Abreha T , Alemu SG , Anez A , Anstey NM , Aseffa A , Assefa A , Awab GR , Baird JK , Barber BE , Borghini-Fuhrer I , D'Alessandro U , Dahal P , Daher A , de Vries PJ , Erhart A , Gomes MSM , Grigg MJ , Hwang J , Kager PA , Ketema T , Khan WA , Lacerda MVG , Leslie T , Ley B , Lidia K , Monteiro WM , Pereira DB , Phan GT , Phyo AP , Rowland M , Saravu K , Sibley CH , Siqueira AM , Stepniewska K , Taylor WRJ , Thwaites G , Tran BQ , Hien TT , Vieira JLF , Wangchuk S , Watson J , William T , Woodrow CJ , Nosten F , Guerin PJ , White NJ , Price RN . BMC Med 2019 17 (1) 151 BACKGROUND: Malaria causes a reduction in haemoglobin that is compounded by primaquine, particularly in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency. The aim of this study was to determine the relative contributions to red cell loss of malaria and primaquine in patients with uncomplicated Plasmodium vivax. METHODS: A systematic review identified P. vivax efficacy studies of chloroquine with or without primaquine published between January 2000 and March 2017. Individual patient data were pooled using standardised methodology, and the haematological response versus time was quantified using a multivariable linear mixed effects model with non-linear terms for time. Mean differences in haemoglobin between treatment groups at day of nadir and day 42 were estimated from this model. RESULTS: In total, 3421 patients from 29 studies were included: 1692 (49.5%) with normal G6PD status, 1701 (49.7%) with unknown status and 28 (0.8%) deficient or borderline individuals. Of 1975 patients treated with chloroquine alone, the mean haemoglobin fell from 12.22 g/dL [95% CI 11.93, 12.50] on day 0 to a nadir of 11.64 g/dL [11.36, 11.93] on day 2, before rising to 12.88 g/dL [12.60, 13.17] on day 42. In comparison to chloroquine alone, the mean haemoglobin in 1446 patients treated with chloroquine plus primaquine was - 0.13 g/dL [- 0.27, 0.01] lower at day of nadir (p = 0.072), but 0.49 g/dL [0.28, 0.69] higher by day 42 (p < 0.001). On day 42, patients with recurrent parasitaemia had a mean haemoglobin concentration - 0.72 g/dL [- 0.90, - 0.54] lower than patients without recurrence (p < 0.001). Seven days after starting primaquine, G6PD normal patients had a 0.3% (1/389) risk of clinically significant haemolysis (fall in haemoglobin > 25% to < 7 g/dL) and a 1% (4/389) risk of a fall in haemoglobin > 5 g/dL. CONCLUSIONS: Primaquine has the potential to reduce malaria-related anaemia at day 42 and beyond by preventing recurrent parasitaemia. Its widespread implementation will require accurate diagnosis of G6PD deficiency to reduce the risk of drug-induced haemolysis in vulnerable individuals. TRIAL REGISTRATION: This trial was registered with PROSPERO: CRD42016053312. The date of the first registration was 23 December 2016. |
Injury-related gaining momentum as external causes of deaths in Ethiopian health and demographic surveillance sites: evidence from verbal autopsy study
Gelaye KA , Tessema F , Tariku B , Abera SF , Gebru AA , Assefa N , Zelalem D , Dedefo M , Kondal M , Kote M , Sisay MM , Mekonnen W , Terefe MW , Biks GA , Eshetu F , Abera M , Fekadu Y , Hailu GB , Tilahun E , Lakew Y . Glob Health Action 2018 11 (1) 1430669 BACKGROUND: In Ethiopia, though all kinds of mortality due to external causes are an important component of overall mortality often not counted or documented on an individual basis. OBJECTIVE: The aim of this study was to describe the patterns of mortality from external causes using verbal autopsy (VA) method at the Ethiopian HDSS Network sites. METHODS: All deaths at Ethiopian HDSS sites were routinely registered and followed up with VA interviews. The VA forms comprised deaths up to 28 days, between four weeks and 14 years and 15 years and above. The cause of a death was ascertained based on an interview with next of families or other caregivers using a standardized questionnaire that draws information on signs, symptoms, medical history and circumstances preceding death after 45 days mourning period. Two physician assigned probable causes of death as underlying, immediate and contributing factors independently using information in VA forms based on the WHO ICD-10 and VA code system. Disagreed cases sent to third physician for independent review and diagnosis. The final cause of death considered when two of the three physicians assigned underlying cause of death; otherwise, labeled as undetermined. RESULTS: In the period from 2009 to 2013, a total of 9719 deaths were registered. Of the total deaths, 623 (6.4%) were from external causes. Of these, accidental drowning and submersion, 136 (21.8%), accidental fall, 113 (18.1%) and transport-related accidents, 112 (18.0%) were the topmost three leading external causes of deaths. About 436 (70.0%) of deaths were from the age group above 15 years old. Drowning and submersion and transport-related accidents were high in age group between 5 and 14 years old. CONCLUSION: In this study, external causes of death are significant public health problems and require attention as one of prior health agenda. |
The Global Trachoma Mapping Project: methodology of a 34-country population-based study
Solomon AW , Pavluck AL , Courtright P , Aboe A , Adamu L , Alemayehu W , Alemu M , Alexander ND , Kello AB , Bero B , Brooker SJ , Chu BK , Dejene M , Emerson PM , Flueckiger RM , Gadisa S , Gass K , Gebre T , Habtamu Z , Harvey E , Haslam D , King JD , Mesurier RL , Lewallen S , Lietman TM , MacArthur C , Mariotti SP , Massey A , Mathieu E , Mekasha A , Millar T , Mpyet C , Muñoz BE , Ngondi J , Ogden S , Pearce J , Sarah V , Sisay A , Smith JL , Taylor HR , Thomson J , West SK , Willis R , Bush S , Haddad D , Foster A . Ophthalmic Epidemiol 2015 22 (3) 214-25 PURPOSE: To complete the baseline trachoma map worldwide by conducting population-based surveys in an estimated 1238 suspected endemic districts of 34 countries. METHODS: A series of national and sub-national projects owned, managed and staffed by ministries of health, conduct house-to-house cluster random sample surveys in evaluation units, which generally correspond to "health district" size: populations of 100,000-250,000 people. In each evaluation unit, we invite all residents aged 1 year and older from h households in each of c clusters to be examined for clinical signs of trachoma, where h is the number of households that can be seen by 1 team in 1 day, and the product h x c is calculated to facilitate recruitment of 1019 children aged 1-9 years. In addition to individual-level demographic and clinical data, household-level water, sanitation and hygiene data are entered into the purpose-built LINKS application on Android smartphones, transmitted to the Cloud, and cleaned, analyzed and ministry-of-health-approved via a secure web-based portal. The main outcome measures are the evaluation unit-level prevalence of follicular trachoma in children aged 1-9 years, prevalence of trachomatous trichiasis in adults aged 15 + years, percentage of households using safe methods for disposal of human feces, and percentage of households with proximate access to water for personal hygiene purposes. RESULTS: In the first year of fieldwork, 347 field teams commenced work in 21 projects in 7 countries. CONCLUSION: With an approach that is innovative in design and scale, we aim to complete baseline mapping of trachoma throughout the world in 2015. |
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