Last data update: May 20, 2024. (Total: 46824 publications since 2009)
Records 1-21 (of 21 Records) |
Query Trace: Romero-Steiner S [original query] |
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A policy analysis of preparedness for hurricane evacuations in the United States, 1990 to 2019: Implementation in coastal states
Logan M , Bradley BM , Chen B , Kruger J , Van Meter J , Paetznick B , Smith MJ , Romero-Steiner S . Health Secur 2021 20 (1) 65-73 Hurricane or typhoon evacuations in the United States are typically managed by state, territorial, or tribal emergency management officials with federal, state, and local agency operational support. The evacuation process may involve issuing mandatory or "voluntary" evacuation orders to alert the community and mitigate loss of life and injury. We conducted an analysis of state and local hurricane evacuation policies identified through a literature review (January 1990 to June 2019) and key informant interviews with state public health and emergency management officials in Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, and Texas in October and November 2019. Findings from the literature review show that most gaps in hurricane evacuation preparedness-based on 44 policy-related publications identified in the review-could be categorized into 4 themes: shelters, evacuation decisionmaking, at-risk populations, and transportation. Findings from key informant interviews for 7 states revealed that coastal states have been able to address most of these gaps since Hurricane Katrina in 2005. However, an important remaining gap in preparedness is providing timely warnings to at-risk populations during hurricane evacuations. |
An innovative United States-Mexico community outreach initiative for Hispanic and Latino people in the United States: A collaborative public health network
Flynn MA , Rodriguez Lainz A , Lara J , Rosales C , Feldstein F , Dominguez K , Wolkin A , Sierra Medal IR , Tonda J , Romero-Steiner S , Dicent-Taillepierre J , Rangel Gómez MG . Public Health Rep 2021 136 (3) 287-294 Collaborative partnerships are a useful approach to improve health conditions of disadvantaged populations. The Ventanillas de Salud (VDS) ("Health Windows") and Mobile Health Units (MHUs) are a collaborative initiative of the Mexican government and US public health organizations that use mechanisms such as health fairs and mobile clinics to provide health information, screenings, preventive measures (eg, vaccines), and health services to Mexican people, other Hispanic people, and underserved populations (eg, American Indian/Alaska Native people, geographically isolated people, uninsured people) across the United States. From 2013 through 2019, the VDS served 10.5 million people (an average of 1.5 million people per year) at Mexican consulates in the United States, and MHUs served 115 461 people from 2016 through 2019. We describe 3 community outreach projects and their impact on improving the health of Hispanic people in the United States. The first project is an ongoing collaboration between VDS and the Centers for Disease Control and Prevention (CDC) to address occupational health inequities among Hispanic people. The second project was a collaboration between VDS and CDC to provide Hispanic people with information about Zika virus infection and health education. The third project is a collaboration between MHUs and the University of Arizona to provide basic health services to Hispanic communities in Pima and Maricopa counties, Arizona. The VDS/MHU model uses a collaborative approach that should be further assessed to better understand its impact on both the US-born and non-US-born Hispanic population and the public at large in locations where it is implemented. |
Hurricane evacuation laws in eight southern U.S. coastal states - December 2018
Kruger J , Smith MJ , Chen B , Paetznick B , Bradley BM , Abraha R , Logan M , Chang ER , Sunshine G , Romero-Steiner S . MMWR Morb Mortal Wkly Rep 2020 69 (36) 1233-1237 National Preparedness month is observed every September as a public service reminder of the importance of personal and community preparedness for all events; it coincides with the peak of the hurricane season in the United States. Severe storms and hurricanes can have long-lasting effects at all community levels. Persons who are prepared and well-informed are often better able to protect themselves and others (1). Major hurricanes can devastate low-lying coastal areas and cause injury and loss of life from storm surge, flooding, and high winds (2). State and local government entities play a significant role in preparing communities for hurricanes and by evacuating coastal communities before landfall to reduce loss of life from flooding, wind, and power outages (3). Laws can further improve planning and outreach for catastrophic events by ensuring explicit statutory authority over evacuations of communities at risk (4). State evacuation laws vary widely and might not adequately address information and communication flows to reach populations living in disaster-prone areas who are at risk. To understand the range of evacuation laws in coastal communities that historically have been affected by hurricanes, a systematic policy scan of the existing laws supporting hurricane evacuation in eight southern coastal states (Alabama, Florida, Georgia, Louisiana, Mississippi, North Carolina, South Carolina, and Texas) was conducted. After conducting a thematic analysis, this report found that all eight states have laws to execute evacuation orders, traffic control (egress/ingress), and evacuation to shelters. However, only four of the states have laws related to community outreach, delivery of public education programs, and public notice requirements. The findings in this report suggest a need for authorities in hurricane-prone states to review how to execute evacuation policies, particularly with respect to community outreach and communication to populations at risk. Implementation of state evacuation laws and policies that support hurricane evacuation management can help affected persons avoid harm and enhance community resiliency (5). Newly emerging and re-emerging infectious diseases, such as SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), have and will continue to additionally challenge hurricane evacuations. |
Evolution of the public health preparedness and response capability standards to support public health emergency management practices and processes
Martinez D , Talbert T , Romero-Steiner S , Kosmos C , Redd S . Health Secur 2019 17 (6) 430-438 In spring 2011, the Centers for Disease Control and Prevention (CDC) released Public Health Preparedness Capabilities: National Standards for State and Local Planning. The capability standards provide a framework that supports state, local, tribal, and territorial public health agency preparedness planning and response to public health threats and emergencies. In 2017, a project team at the CDC Division of State and Local Readiness incorporated input from subject matter experts, national partners, and stakeholders to update the 2011 capability standards. As a result, CDC released the updated capability standards in October 2018, which were amended in January 2019. The original structure of the 15 capability standards remained unchanged, but updates were made to capability functions, tasks, and resource elements to reflect advances in public health emergency preparedness and response practices since 2011. When the number of functions and tasks in the 2018 capability standards were compared to those in the 2011 capabilities, only 20% (3/15) of the capabilities had a decrease in function number. The majority of changes were at the task level (task numbers changed in 80%, or 12/15, capabilities) in the 2018 version. The capability standards provide public health agencies with a practical framework, informed by updated science and tools, which can guide prioritization of limited resources to strengthen public health agency emergency preparedness and response capacities. |
Serosurveillance of first-year military personnel for hepatitis A and B
Broderick M , Kamili S , Nelson NP , Le T , Faix D , Romero-Steiner S . Am J Public Health 2018 108 S204-s206 The US military utilizes a number of vaccines as strategic medical countermeasures, mandating immunizations in personnel against common infectious diseases, as well as special immunizations against rare and weaponized agents.1 Important among the former are the vaccines against hepatitis A and B, which the military requires of all military accessions into service. While the Advisory Committee on Immunization Practices (ACIP) does not explicitly recommend hepatitis A and B vaccination for military personnel, the military’s rationale for preexposure prophylaxis is based on the likelihood that active duty military personnel may encounter populations for which ACIP does recommend vaccination, and work in countries that have high or intermediate endemicity of hepatitis.2 |
School district crisis preparedness, response, and recovery plans - United States, 2012
Silverman B , Chen B , Brener N , Kruger J , Krishna N , Renard P Jr , Romero-Steiner S , Avchen RN . MMWR Morb Mortal Wkly Rep 2016 65 (36) 949-953 The unique characteristics of children dictate the need for school-based all-hazards response plans during natural disasters, emerging infectious diseases, and terrorism. Schools are a critical community institution serving a vulnerable population that must be accounted for in public health preparedness plans; prepared schools are adopting policies and plans for crisis preparedness, response, and recovery. The importance of having such plans in place is underscored by the development of a new Healthy People 2020 objective (PREP-5) to "increase the percentage of school districts that require schools to include specific topics in their crisis preparedness, response, and recovery plans". Because decisions about such plans are usually made at the school district level, it is important to examine district-level policies and practices. Although previous reports have provided national estimates of the percentage of districts with policies and practices in place, these estimates have not been analyzed by U.S. Census region* and urbanicity.dagger Using data from the 2012 School Health Policies and Practices Study (SHPPS), this report examines policies and practices related to school district preparedness, response, and recovery. In general, districts in the Midwest were less likely to require schools to include specific topics in their crisis preparedness plans than districts in the Northeast and South. Urban districts tended to be more likely than nonurban districts to require specific topics in school preparedness plans. Southern districts tended to be more likely than districts in other regions to engage with partners when developing plans. No differences in district collaboration (with the exception of local fire department engagement) were observed by level of urbanicity. School-based preparedness planning needs to be coordinated with interdisciplinary community partners to achieve Healthy People 2020 PREP-5 objectives for this vulnerable population. |
Immune Responses in U.S. Military Personnel Who Received Meningococcal Conjugate Vaccine (MenACWY) Concomitantly with Other Vaccines Were Higher than in Personnel Who Received MenACWY Alone
Broderick MP , Romero-Steiner S , Rajam G , Johnson SE , Milton A , Kim E , Choi LJ , Radin JM , Schmidt DS , Carlone GM , Messonnier N , Faix DJ . Clin Vaccine Immunol 2016 23 (8) 672-80 Immunological responses to vaccination can differ depending on whether the vaccine is given alone or with other vaccines. This study was a retrospective evaluation of the immunogenicity of a tetravalent meningococcal conjugate vaccine (MenACWY) administered alone (n = 41) or concomitantly with other vaccines (n = 279) to United States military personnel (mean age = 21.6 years) entering the military between 2006 and 2008. Concomitant vaccines included tetanus/diphtheria (Td), inactivated polio vaccine (IPV), hepatitis vaccines, various influenza vaccines, among others; two vaccine groups excluded Tdap and IPV. Immune responses were evaluated in baseline and post-vaccination sera for Neisseria meningitidis serogroups C and Y 1-12 months (mean = 4.96) following vaccination. Functional antibodies were measured by using a serum bactericidal antibody assay with rabbit complement (rSBA) and by measurement of serogroup-specific immunoglobulin G (IgG) antibodies. The percentage of vaccinees reaching threshold levels (IgG ≥2 mug/mL; rSBA titer ≥8) corresponding to an immunologic response was higher post-vaccination than at baseline (p < 0.001). Administration of MenACWY along with other vaccines was associated with higher geometric means of IgG concentrations and rSBA titers than those measured 4.60 months after a single dose of MenACWY. In addition, higher percentages of vaccinees reached the immunological threshold (odds ratios [ORs] range = 1.5 to 21.7) and more of them seroconverted (ORs range = 1.8 to 4.8) when MenACWY was administered with any other vaccine than when administered alone. Additional prospective randomized clinical trials are needed to confirm the observed differences among groups in the immune response to MenACWY when given concomitantly with other vaccines to United States military personnel. |
Naturally acquired antibodies against Haemophilus influenzae type a in Aboriginal adults, Canada
Nix EB , Williams K , Cox AD , St Michael F , Romero-Steiner S , Schmidt DS , McCready WG , Ulanova M . Emerg Infect Dis 2015 21 (2) 273-9 In the post-Haemophilus influenzae type b (Hib) vaccine era that began in the 1980's, H. influenzae type a (Hia) emerged as a prominent cause of invasive disease in North American Aboriginal populations. To test whether a lack of naturally acquired antibodies may underlie increased rates of invasive Hia disease, we compared serum bactericidal activity against Hia and Hib and IgG and IgM against capsular polysaccharide between Canadian Aboriginal and non-Aboriginal healthy and immunocompromised adults. Both healthy and immunocompromised Aboriginal adults exhibited significantly higher bactericidal antibody titers against Hia than did non-Aboriginal adults (p = 0.042 and 0.045 respectively), with no difference in functional antibody activity against Hib. IgM concentrations against Hia were higher than IgG in most study groups; the inverse was true for antibody concentrations against Hib. Our results indicate that Aboriginal adults possess substantial serum bactericidal activity against Hia that is mostly due to IgM antibodies. The presence of sustained IgM against Hia suggests recent Hia exposure. |
Effect of multiple, simultaneous vaccines on polio seroresponse and associated health outcomes
Broderick MP , Oberste MS , Moore D , Romero-Steiner S , Hansen CJ , Faix DJ . Vaccine 2014 33 (24) 2842-8 BACKGROUND: Administration of multiple simultaneous vaccines to infants, children, and military recruits is not uncommon. However, little research exists to examine associated serological and health effects, especially in adults. METHOD: We retrospectively examined 416 paired serum specimens from U.S. military subjects who had received the inactivated polio vaccine (IPV) alone or in combination with either 1 other vaccine (<3 group) or 4 other vaccines (>4 group). Each of the 2 groups was subdivided into 2 subgroups in which Tdap was present or absent. RESULTS: The >4 group was associated with a higher proportion of polio seroconversions than the <3 group (95% vs. 58%, respectively, p<0.01). Analysis of the <3 subgroup that excluded Tdap vs. the >4 subgroup that excluded Tdap showed no difference between them (p>0.1). However, the >4 subgroup that included Tdap had significantly more seroconversions than either the <3 subgroup that excluded Tdap or the >4 subgroup that excluded Tdap (p<0.01). Overall, at least 98% of subjects were at or above the putative level of seroprotection both pre- and post-vaccination, yet at least 81% of subjects seroconverted. In an analysis of 400 of the subjects in which clinic in- and outpatient encounters were counted over the course of 1 year following vaccinations, there was no significant difference between the 2 groups (p>0.1). CONCLUSION: A combination of >4 vaccines including IPV appeared to have an immunopotentiation effect on polio seroconversion, and Tdap in particular was a strong candidate for an important role. The dose of IPV we studied in our subjects, who already had a high level of seroprotection, acted as a booster. In addition, there appear to be no negative health consequences from receiving few versus more multiple simultaneous vaccinations. |
Persistence of serogroup C antibody responses following quadrivalent meningococcal conjugate vaccination in United States military personnel
Patel M , Romero-Steiner S , Broderick MP , Thomas CG , Plikaytis BD , Schmidt DS , Johnson SE , Milton AS , Carlone GM , Clark TA , Messonnier NE , Cohn AC , Faix DJ . Vaccine 2014 32 (30) 3805-9 Serogroup C meningococcal (MenC) disease accounts for one-third of all meningococcal cases and causes meningococcal outbreaks in the U.S. Quadrivalent meningococcal vaccine conjugated to diphtheria toxoid (MenACYWD) was recommended in 2005 for adolescents and high risk groups such as military recruits. We evaluated anti-MenC antibody persistence in U.S. military personnel vaccinated with either MenACYWD or meningococcal polysaccharide vaccine (MPSV4). Twelve hundred subjects vaccinated with MenACYWD from 2006 to 2008 or MPSV4 from 2002 to 2004 were randomly selected from the Defense Medical Surveillance System. Baseline serologic responses to MenC were assessed in all subjects; 100 subjects per vaccine group were tested during one of the following six post-vaccination time-points: 5-7, 11-13, 17-19, 23-25, 29-31, or 35-37 months. Anti-MenC geometric mean titers (GMT) were measured by rabbit complement serum bactericidal assay (rSBA) and geometric mean concentrations (GMC) by enzyme-linked immunosorbent assay (ELISA). Continuous variables were compared using the Wilcoxon rank sum test and the proportion of subjects with an rSBA titer ≥8 by chi-square. Pre-vaccination rSBA GMT was <8 for the MenACWYD group. rSBA GMT increased to 703 at 5-7 months post-vaccination and decreased by 94% to 43 at 3 years post-vaccination. GMT was significantly lower in the MenACWYD group at 5-7 months post-vaccination compared to the MPSV4 group. The percentage of MenACWYD recipients achieving an rSBA titer of ≥8 decreased from 87% at 5-7 months to 54% at 3 years. There were no significant differences between vaccine groups in the proportion of subjects with a titer of ≥8 at any time-point. GMC for the MenACWYD group was 0.14mug/mL at baseline, 1.07mug/mL at 5-7 months, and 0.66mug/mL at 3 years, and significantly lower than the MPSV4 group at all time-points. Anti-MenC responses wane following vaccination with MenACYWD; a booster dose is needed to maintain protective levels of circulating antibody. |
Molecular signatures of antibody responses derived from a systems biology study of five human vaccines.
Li S , Rouphael N , Duraisingham S , Romero-Steiner S , Presnell S , Davis C , Schmidt DS , Johnson SE , Milton A , Rajam G , Kasturi S , Carlone GM , Quinn C , Chaussabel D , Palucka AK , Mulligan MJ , Ahmed R , Stephens DS , Nakaya HI , Pulendran B . Nat Immunol 2013 15 (2) 195-204 Many vaccines induce protective immunity via antibodies. Systems biology approaches have been used to determine signatures that can be used to predict vaccine-induced immunity in humans, but whether there is a 'universal signature' that can be used to predict antibody responses to any vaccine is unknown. Here we did systems analyses of immune responses to the polysaccharide and conjugate vaccines against meningococcus in healthy adults, in the broader context of published studies of vaccines against yellow fever virus and influenza virus. To achieve this, we did a large-scale network integration of publicly available human blood transcriptomes and systems-scale databases in specific biological contexts and deduced a set of transcription modules in blood. Those modules revealed distinct transcriptional signatures of antibody responses to different classes of vaccines, which provided key insights into primary viral, protein recall and anti-polysaccharide responses. Our results elucidate the early transcriptional programs that orchestrate vaccine immunity in humans and demonstrate the power of integrative network modeling. |
Absence of high molecular weight proteins 1 and/or 2 is associated with decreased adherence among non-typeable Haemophilus influenzae clinical isolates
Vuong J , Wang X , Theodore JM , Whitmon J , Gomez de Leon P , Mayer LW , Carlone GM , Romero-Steiner S . J Med Microbiol 2013 62 1649-56 High molecular weight (Hmw) proteins 1 and 2, type IV pilin protein (PilA), outer-membrane protein P5 (OmpP5), Haemophilus protein D (Hpd) and Haemophilus adhesive protein (Hap) are surface proteins involved in the adherence of non-typeable Haemophilus influenzae. One hundred clinical isolates were evaluated for the presence of the genes encoding these proteins by PCR and for their adherence capacity (AC) to Detroit 562 nasopharyngeal cells (D562). The majority of isolates were from blood (77/100); other sites were also represented. Confluent D562 monolayers (1.2x10(5) cells per well) were inoculated with standardized minimal infective doses (m.o.i.) of 10(2), 10(3) or 10(4) c.f.u. per well. The AC was categorized as low (<10 %) or high (≥10 %) depending on the percentage of c.f.u. adhering per well. All the isolates evaluated showed adherence: 69/100 (69 %) demonstrated high adherence, while 31/100 (31 %) showed low adherence. Of all the genes evaluated, hmw1A and/or hmw2A were detected in 69/100 (69 %) of isolates. The presence of hmw1A and/or hmw2A was associated with increased adherence to D562 cells (P≤0.001). Dot immunoblots were performed to detect protein expression using mAbs 3D6, AD6 and 10C5. Among the high-adherence isolates (n = 69), 72 % reacted with 3D6 and 21 % with 10C5. Our data indicate that the absence of Hmw1 and/or Hmw2 was associated with decreased adherence to D562 cells. |
Phenotypic, genomic, and transcriptional characterization of Streptococcus pneumoniae interacting with human pharyngeal cells.
Kimaro Mlacha SZ , Romero-Steiner S , Hotopp JC , Kumar N , Ishmael N , Riley DR , Farooq U , Creasy TH , Tallon LJ , Liu X , Goldsmith CS , Sampson J , Carlone GM , Hollingshead SK , Scott JA , Tettelin H . BMC Genomics 2013 14 383 BACKGROUND: Streptococcus pneumoniae is a leading cause of childhood morbidity and mortality worldwide, despite the availability of effective pneumococcal vaccines. Understanding the molecular interactions between the bacterium and the host will contribute to the control and prevention of pneumococcal disease. RESULTS: We used a combination of adherence assays, mutagenesis and functional genomics to identify novel factors involved in adherence. By contrasting these processes in two pneumococcal strains, TIGR4 and G54, we showed that adherence and invasion capacities vary markedly by strain. Electron microscopy showed more adherent bacteria in association with membranous pseudopodia in the TIGR4 strain. Operons for cell wall phosphorylcholine incorporation (lic), manganese transport (psa) and phosphate utilization (phn) were up-regulated in both strains on exposure to epithelial cells. Pneumolysin, pili, stress protection genes (adhC-czcD) and genes of the type II fatty acid synthesis pathway were highly expressed in the naturally more invasive strain, TIGR4. Deletion mutagenesis of five gene regions identified as regulated in this study revealed attenuation in adherence. Most strikingly, SP_1922 which was predicted to contain a B-cell epitope and revealed significant attenuation in adherence, appeared to be expressed as a part of an operon that includes the gene encoding the cytoplasmic pore-forming toxin and vaccine candidate, pneumolysin. CONCLUSION: This work identifies a list of novel potential pneumococcal adherence determinants. |
Measurement of Haemophilus influenzae type a capsular polysaccharide antibodies in cord blood sera
Schmidt DS , Bieging KT , Gomez-de-Leon P , Villasenor-Sierra A , Inostroza J , Robbins JB , Schneerson R , Carlone GM , Romero-Steiner S . Pediatr Infect Dis J 2012 31 (8) 876-8 We measured anti-Hia capsular polysaccharide serum immunoglobulin G (IgG) antibodies in cord blood sera from Mexican (n=68) and Chilean mothers (n=72) by ELISA. Measurable antibodies were found in 79.3% of samples. IgG antibodies correlated with serum bactericidal activity (r=0.66). This ELISA can be used for the evaluation of adaptive immune responses to Hia and sero-surveillance studies in populations at risk. |
Establishment of a new human pneumococcal standard reference serum, 007sp
Goldblatt D , Plikaytis BD , Akkoyunlu M , Antonello J , Ashton L , Blake M , Burton R , Care R , Durant N , Feavers I , Fernsten P , Fievet F , Giardina P , Jansen K , Katz L , Kierstead L , Lee L , Lin J , Maisonneuve J , Nahm MH , Raab J , Romero-Steiner S , Rose C , Schmidt D , Stapleton J , Carlone GM . Clin Vaccine Immunol 2011 18 (10) 1728-36 Lot 89SF has been the reference standard serum pool used in pneumococcal enzyme-linked immunosorbent assays (ELISAs) since 1990. In 2005, it was estimated that there remained between 2 and 5 years' supply of lot 89SF. Since lot 89SF was the reference standard used in the evaluation of the seven-valent pneumococcal conjugate vaccine Prevnar (PCV7), the link to clinical efficacy would be severed if stocks became completely depleted. Furthermore, demonstration of immune responses comparable to those elicited by PCV7 is a licensure approach used for new pneumococcal conjugate vaccines, so a replacement reference standard was required. A total of 278 volunteers were immunized with the 23-valent unconjugated polysaccharide vaccine Pneumovax II, and a unit of blood was obtained twice within 120 days following immunization. Plasma was prepared, pooled, and confirmed to be free from hepatitis B virus (HBV), hepatitis C virus (HCV), and HIV. The pooled serum was poured at 6 ml per vial into 15,333 vials and lyophilized. Immunological bridging of 007sp to 89SF was used to establish equivalent reference values for 13 pneumococcal capsular serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) by five independent laboratories. Antibody concentrations in 007sp were established relative to the lot 89SF reference preparation using the WHO reference ELISA. Subsequently, 12 existing WHO calibration sera had concentrations reassigned for 13 pneumococcal serotypes using new serum 007sp as the reference, and these were compared to concentrations relative to the original reference serum. Agreement was excellent for the 12 WHO calibration sera. The 007sp preparation has replaced 89SF as the pneumococcal reference standard. Sufficient quantity of this new preparation is available such that, with judicious use, it should be available for at least 25 years. |
Repeat revaccination with 23-valent pneumococcal polysaccharide vaccine among adults aged 55-74 years living in Alaska: no evidence of hyporesponsiveness
Hammitt LL , Bulkow LR , Singleton RJ , Nuorti JP , Hummel KB , Miernyk KM , Zanis C , Whaley M , Romero-Steiner S , Butler JC , Rudolph K , Hennessy TW . Vaccine 2011 29 (12) 2287-95 BACKGROUND: Older adults are at highest risk of invasive pneumococcal disease (IPD) and are recommended to receive vaccination with 23-valent pneumococcal polysaccharide vaccine (PPV23). Antibody concentrations decline following vaccination. We evaluated the immunogenicity and reactogenicity of revaccination and repeat revaccination. METHODS: Adults aged 55-74 years were vaccinated with a 1st to 4th dose of PPV23. Participants were eligible for revaccination if a minimum of 6 years had passed since their last dose of PPV23. Blood collected on the day of vaccination and 30 days later was analyzed by ELISA for IgG to five serotypes. Functional antibody activity was measured using an opsonophagocytic killing (OPK) assay. Reactions to vaccination were documented. RESULTS: Subjects were vaccinated with a 1st dose (n=123), 2nd dose (n=121), or 3rd or 4th dose (n=71) of PPV23. The post-vaccination IgG geometric mean concentrations (GMCs) were similar among first-time vaccinees and re-vaccinees for all serotypes with the exception of a lower GMC for serotype 1 in re-vaccinees. The post-vaccination OPK geometric mean titers (GMTs) were similar among first-time vaccinees and re-vaccinees with the exception of a higher GMT for serotype 6B in re-vaccinees. Compared to first-time vaccinees, re-vaccinees reported more joint pain (p=0.003), fatigue (p=0.027), headache (p=0.011), swelling (p=0.009), and moderate limitation in arm movement (p=0.015). CONCLUSIONS: Repeat revaccination with PPV23, administered 6 or more years after the prior dose, was immunogenic and generally well tolerated. |
Evaluation of serum bactericidal antibody assays for Haemophilus influenzae serotype a
Rouphael NG , Satola S , Farley MM , Rudolph K , Schmidt DS , Gomez-de-Leon P , Robbins JB , Schneerson R , Carlone GM , Romero-Steiner S . Clin Vaccine Immunol 2010 18 (2) 243-7 Haemophilus influenzae type a (Hia) is an important pathogen for some American Indian, Alaskan natives and Northern Canada aboriginal populations. Assays to measure serum bactericidal activity (SBA) to Hia have not been developed or validated. Here we describe two methods for the measurement of SBA: SBA with a viability end-point (CFU counts) and SBA with a fluorometric end-point using alamarBlue as metabolic indicator. Both SBA assays measure Hia-specific functional antibody and correlate with anti-Hia IgG ELISA concentration of naturally-acquired antibodies. |
Multilaboratory comparison of Streptococcus pneumoniae opsonophagocytic killing assays and their level of agreement for the determination of functional antibody activity in human reference sera
Rose CE , Romero-Steiner S , Burton RL , Carlone GM , Goldblatt D , Nahm MH , Ashton L , Haston M , Ekstrom N , Haikala R , Kayhty H , Henckaerts I , Durant N , Poolman JT , Fernsten P , Yu X , Hu BT , Jansen KU , Blake M , Simonetti E , Hermans PW , Plikaytis BD . Clin Vaccine Immunol 2010 18 (1) 135-42 Antibody mediated killing of Streptococcus pneumoniae (pneumococcus) by phagocytes is an important mechanism of protection of the human host against pneumococcal infections. Measurement of opsonophagocytic antibodies using a standardized opsonophagocytic assay (OPA) is important for the evaluation of candidate vaccines and a requirement for the licensure of new pneumococcal conjugate vaccine formulations. We assessed agreement among six laboratories that used their own optimized OPAs on a panel of 16 human reference sera for 13 pneumococcal serotypes. Consensus titers, estimated using an analysis of variance (ANOVA) mixed-effects model, provided a common reference to assess agreement among these laboratories. Agreement was evaluated using assay accuracy, reproducibility, repeatability, precision and bias. We also reviewed four acceptance criteria intervals for assessing the comparability of protocols when assaying the same reference sera. The precision, accuracy and concordance results among laboratories and the consensus titers revealed acceptable agreement. Results of this study indicate that the bioassays evaluated in this study are robust and the resultant OPA values are reproducible for the determination of functional antibody titers specific to 13 pneumococcal serotypes when performed by laboratories using highly standardized but not identical assays. The statistical methodologies employed in this study may serve as a template to evaluate future multilaboratory studies. |
Concomitant administration of recombinant PsaA and PCV7 reduces Streptococcus pneumoniae serotype 19A colonization in a murine model
Whaley MJ , Sampson JS , Johnson SE , Rajam G , Stinson-Parks A , Holder P , Mauro E , Romero-Steiner S , Carlone GM , Ades EW . Vaccine 2010 28 (18) 3071-5 A murine colonization model was used to determine the effect of co-administering 7-valent polysaccharide-protein conjugate vaccine and pneumococcal surface adhesin A. Mice were challenged intranasally with either PCV7 serotypes, 4 or 14, or a non-PCV7 serotype, 19A. Post-challenge samples were evaluated for IgG antibody levels, opsonophagocytic activity, and nasopharyngeal colonization. No interference was observed between immune responses from the concomitant and individual immunizations. Concomitant immunizations reduced carriage for tested serotypes; largest reduction was observed for 19A. From these mouse studies, co-administering pneumococcal antigens appear to expand coverage and reduce colonization against a non-PCV7 serotype without inhibiting immunogenicity to other serotypes. |
An interlaboratory comparison of three multiplexed bead-based immunoassays for measuring serum antibodies to pneumococcal polysaccharides
Whaley MJ , Rose C , Martinez J , Laher G , Sammons DL , Smith JP , Snawder JE , Borrow R , Biagini RE , Plikaytis B , Carlone GM , Romero-Steiner S . Clin Vaccine Immunol 2010 17 (5) 862-9 Serotype-specific IgG, as quantified by a standardized WHO ELISA, is a serologic end-point used to evaluate pneumococcal polysaccharide-based vaccine immunogenicity. Antibodies to each vaccine polysaccharide in licensed multivalent vaccines are quantified separately; this is laborious and consumes serum. We compared three bead-based immunoassays, a commercial assay (xMAP(R)Pneumo14, Luminex) and two in-house assays (Health Protection Agency [HPA] and Centers for Disease Control and Prevention [CDC]) using WHO recommended standard reference and reference sera (n=11) from vaccinated adults. Multiple comparisons of the IgG concentrations for seven conjugate vaccine serotypes were performed by sample (percent error), serotype (equivalency testing), and laboratory (concordance correlation coefficient [CCC]). When comparing concentrations by sample, bead-based immunoassays generally yielded higher antibody concentrations than ELISA and had higher variability for serotypes 6B, 18C, and 23F. None of the three assays met the current WHO recommendation of 75% of sera falling within +/-40% of the assigned antibody concentrations for all seven serotypes. When compared by serotype, CDC and HPA were equivalent for 5 of 7 serotypes, whereas Luminex was equivalent for 4 of 7 serotypes. When overall mean IgG concentrations were compared by laboratories, a higher level of agreement, CCC close to 1, was found among bead-based immunoassays than between the assays and WHO assignments. When compared to WHO assignments, the HPA assay out performed (r = 0.920, rc = 0.894, Ca = 0.972) the other assays. Additional testing with sera from immunogenicity studies should demonstrate the applicability of this methodology for vaccine evaluation. |
Revaccination with a 23-valent pneumococcal polysaccharide vaccine induces elevated and persistent functional antibody responses in adults aged 65 > or = years
Manoff SB , Liss C , Caulfield MJ , Marchese RD , Silber J , Boslego J , Romero-Steiner S , Rajam G , Glass NE , Whitney CG , Carlone GM . J Infect Dis 2010 201 (4) 525-33 BACKGROUND: Older adults are at high risk of developing invasive pneumococcal disease, but the optimal timing and number of vaccine doses needed to prevent disease among this group are unknown. We compared revaccination with 23-valent pneumococcal polysaccharide vaccine (PN23) with primary vaccination for eliciting initial and persistent functional antibody responses. METHODS: Subjects aged > or = 65 years were enrolled. Functional (opsonic) and total immunoglobulin (Ig) G antibody levels were measured following either PN23 primary vaccination (n = 60) or revaccination 3-5 years after receiving a first PN23 vaccination (n = 60). Antibody against vaccine serotypes 4, 14, and 23F was measured at prevaccination (day 0), 30 days after vaccination, and 5 years after vaccination. RESULTS: By day 30, both primary vaccination and revaccination induced significant increases in opsonic and IgG antibody levels. Day 30 levels following revaccination were slightly lower but not significantly different than those after primary vaccination. Year 5 levels were similar in both groups and remained significantly higher than prevaccination levels for primary vaccination subjects. There was good agreement between postvaccination opsonic and IgG antibody levels. CONCLUSIONS: Revaccination of older adults with PN23 was comparable to primary vaccination for inducing elevated and persistent functional and IgG antibody responses. |
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