Trials in vaccinologyPub Date : 2013-01-01Epub Date: 2013-04-20DOI: 10.1016/j.trivac.2013.03.001
Geert Leroux-Roels , Simon Dobson , David I. Bernstein , Sandra Fowler , Barbara Romanowski , Isabel Leroux-Roels , Brigitte Cheuvart , Thomas Heineman , Gary Dubin
{"title":"Clinical evaluation to confirm the manufacturing consistency of three lots of an adjuvanted glycoprotein D genital herpes vaccine in healthy seronegative pre-teen and adolescent girls: A phase III multi-center double-blind randomized trial","authors":"Geert Leroux-Roels , Simon Dobson , David I. Bernstein , Sandra Fowler , Barbara Romanowski , Isabel Leroux-Roels , Brigitte Cheuvart , Thomas Heineman , Gary Dubin","doi":"10.1016/j.trivac.2013.03.001","DOIUrl":"10.1016/j.trivac.2013.03.001","url":null,"abstract":"<div><h3>Objective</h3><p>To evaluate the consistency of three commercial scale lots of candidate herpes simplex virus (HSV) type 2 (HSV-2) vaccine in adolescent girls.</p></div><div><h3>Methods</h3><p>A total of 554 healthy girls aged 10–17 years, from Belgium, Canada, and United States, were enrolled and randomized to receive one of the three manufacturing lots of the candidate glycoprotein D2 vaccine (gD2-AS04, GlaxoSmithKline Vaccines) according to a 0, 1 and 6-month schedule. Consistency was based on anti-gD geometric mean titers (GMTs) 1 month post-dose 3 among HSV seronegative subjects complying to study procedures (<em>N</em> = 312): two-sided 90% confidence interval (CI) for the GMT ratio between each pair of vaccine lots had to be within the [0.67; 1.5] consistency interval.</p></div><div><h3>Results</h3><p>Pre-specified consistency criteria were reached. At month 2 (1 month after the second vaccine dose) anti-gD antibodies were detected in all study participants, while the proportion of subjects with HSV-2 neutralizing antibodies ranged from 93% to 96.2%, remaining >90% throughout the study (between 93.7% and 96.1% for the three vaccine lot groups at month 12). The three vaccine lots had similar reactogenicity profiles. The incidence of grade 3 solicited or unsolicited adverse events (AEs) ranged from 17.9% to 22.2% of subjects.</p></div><div><h3>Conclusions</h3><p>This study demonstrated the lot-to-lot consistency of three commercial scale production lots of herpes simplex candidate vaccine. The vaccine was immunogenic and had a clinically acceptable safety profile when administered in HSV type 1 and HSV-2 seronegative girls aged 10–17 years. The study was registered at <span>clinicaltrials.gov</span><svg><path></path></svg> (identifier <span>NCT00224471</span><svg><path></path></svg>).</p></div>","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"2 ","pages":"Pages 10-18"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2013.03.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638918","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2013-01-01Epub Date: 2013-09-23DOI: 10.1016/j.trivac.2013.08.001
Charbell M.H. Kury, Marcus M.H. Kury, Raquel M.H. Silva, Francisco A.S. Oliveira, José C. de Moraes, Juliana G.S.A. De Moraes, Christiane C.R. Pereira, Bianca S. Vieira
{"title":"Implementation of the quadrivalent vaccine against HPV in the Municipality of Campos dos Goytacazes, Brazil – A combination of strategies to increase immunization coverage and early reduction of genital warts","authors":"Charbell M.H. Kury, Marcus M.H. Kury, Raquel M.H. Silva, Francisco A.S. Oliveira, José C. de Moraes, Juliana G.S.A. De Moraes, Christiane C.R. Pereira, Bianca S. Vieira","doi":"10.1016/j.trivac.2013.08.001","DOIUrl":"10.1016/j.trivac.2013.08.001","url":null,"abstract":"<div><h3>Introduction</h3><p>Among the more than 100 types of human papillomavirus (HPV), about 90% of genital warts are caused by HPV types 6 and 11; types 16 and 18 cause 70% of cases of cervical cancer. Tracking through Pap associated with condom use are strategies in preventing this condition. Vaccination against HPV has been added to the portfolio of protection. In September 13, 2010, the quadrivalent vaccine against HPV was made available for resident girls between 11 and 15 years of age in the municipality of Campos dos Goytacazes, Rio de Janeiro, Brazil using a hybrid strategy of vaccination.</p></div><div><h3>Objectives</h3><p>Assess vaccination coverage in that municipality after adopting several strategies for active search and missed opportunities for vaccination against HPV. Evaluate acceptance for the vaccine and reasons for refusal the HPV vaccine. Evaluate the frequency and occurrence of adverse events to that vaccine. A survey of reduction of genital warts was also conducted.</p></div><div><h3>Methods</h3><p>A survey of vaccination coverage for the chosen age group was carried out. By previous appointment, schools received vaccination on site; two “D-Days” for municipal vaccination were set along side with the creation of the project “Holidays HPV-free”. The vaccine was also offered in two public permanent sites on a daily basis; Vaccine adverse events were assessed in 1000 adolescents after 96 h of vaccine administration A survey on reduction of genital warts was studied 3 years before and 2 years after introduction of vaccine.</p></div><div><h3>Results</h3><p>The 1st vaccine dose reached about 53%, 90.1% and 87.9% of coverage, respectively in 2010, 2011 and 2012. By using the same model, the complete scheme with 3rd dose reached 0%, 65.1% and 66.2% of coverage status. There were observed a total of 430 local and systemic events in 360 subjects (36% of 1000 girls), stratified by each dose received. No serious adverse events or any hospitalization were reported; We also observed a reduction of about 55% in the incidence of genital warts in women under 21 years old.</p></div><div><h3>Conclusion</h3><p>A hybrid strategy for HPV proved to be effective in vaccinating adolescents in this municipality. HPV vaccine was safe and effective in reducing genital warts, as demonstrated by international studies.</p></div>","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"2 ","pages":"Pages 19-24"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2013.08.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"WITHDRAWN: Generation of high-titer of neutralizing polyclonal antibodies against heat-stable enterotoxin (STa) of enterotoxigenic scherichia coli","authors":"N. Aref, A. Saeed","doi":"10.1016/J.TRIVAC.2012.01.002","DOIUrl":"https://doi.org/10.1016/J.TRIVAC.2012.01.002","url":null,"abstract":"","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2012-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.TRIVAC.2012.01.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-04-14DOI: 10.1016/j.trivac.2012.01.003
Johanna N. Spaans , Jean-Pierre Routy , Cécile Tremblay , Joel Singer , Nicole Bernard , Sanjay Gurunathan , Rafick-Pierre Sékaly , Jonathan B. Angel
{"title":"Optimizing the efficiency of therapeutic HIV vaccine trials: A case for CTN 173","authors":"Johanna N. Spaans , Jean-Pierre Routy , Cécile Tremblay , Joel Singer , Nicole Bernard , Sanjay Gurunathan , Rafick-Pierre Sékaly , Jonathan B. Angel","doi":"10.1016/j.trivac.2012.01.003","DOIUrl":"10.1016/j.trivac.2012.01.003","url":null,"abstract":"<div><h3>Background</h3><p>The introduction of highly active antiretroviral therapy (HAART) has enabled the dramatic reduction in viral replication and the partial restoration of host immune function, albeit at the expense of drug toxicity. Strategies to enhance HIV-specific immunity are required in order to limit ART exposure. Therapeutic vaccination is a promising new approach to enhance immunogenicity and anti-viral activity in people infected with HIV.</p></div><div><h3>Purpose</h3><p>Efficient clinical trial designs are required to optimize therapeutic HIV vaccination strategies. Herein, we describe unique design features and investigational procedures that were applied to a prime-boost therapeutic vaccine trial (CTN 173) to enhance HIV immunity.</p></div><div><h3>Methods</h3><p>CTN 173 was a multicentre, randomized, 3-arm, double-blind placebo controlled trial to evaluate anti-viral activity of therapeutic vaccination with ALVAC<!--> <!-->±<!--> <!-->Remune in chronically infected individuals on HAART. CTN 173 was developed with the specific aim to better characterize patient factors and immunologic parameters associated with vaccine response. This paper discusses the relevance of choice of primary endpoint and statistical approach used in this trial, in relation to vaccine response, patient safety and the identification of optimal target populations for future vaccine trials.</p></div><div><h3>Results</h3><p>Time to event surrogate endpoints of viral response and frequent immunologic monitoring allow for a better characterization of immunologic correlates of vaccine response.</p></div><div><h3>Limitations</h3><p>The clinical implications of delayed viral rebound associated with therapeutic vaccination with ALVAC<!--> <!-->+<!--> <!-->Remune are not yet known and will need to be evaluated on long-term follow-up.</p></div><div><h3>Conclusions</h3><p>Randomized controlled trials such as CTN 173, with well-defined surrogate endpoints and frequent immunologic and virologic monitoring, are necessary to streamline the approach to effective vaccine discovery and to ensure patient safety.</p></div>","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 21-26"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2012.01.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-11-05DOI: 10.1016/j.trivac.2012.10.001
S.V. van de Witte , J. Nauta , K.M. Giezeman-Smits , J.M. de Voogd
{"title":"Trivalent inactivated subunit influenza vaccine Influvac®: 30-year experience of safety and immunogenicity","authors":"S.V. van de Witte , J. Nauta , K.M. Giezeman-Smits , J.M. de Voogd","doi":"10.1016/j.trivac.2012.10.001","DOIUrl":"10.1016/j.trivac.2012.10.001","url":null,"abstract":"<div><h3>Background/objectives</h3><p>Between 1982 and 2011, 84 clinical studies were performed by the manufacturers of Influvac®, including the annual update studies required for licensing in Europe. This paper presents data from a 30-year evaluation of clinical experience with Influvac®.</p></div><div><h3>Subjects and methods</h3><p>In all, 8776 subjects were vaccinated with Influvac®, including healthy adults, healthy elderly subjects, adult and elderly at-risk subjects, and healthy and at-risk children. All subjects received the trivalent inactivated subunit influenza vaccine Influvac® (Abbott, Weesp, The Netherlands). Subjects recorded solicited local and systemic reactions for 3–7<!--> <!-->days after vaccination. Inconvenience was scored in some studies. Unsolicited reports of adverse events were collected up to 21<!--> <!-->days after vaccination. Haemagglutination inhibition (HI) antibody titres were determined before and up to 45<!--> <!-->weeks after vaccination with Influvac®. The immunogenicity of Influvac® was assessed using the criteria of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. Post marketing surveillance data were also analyzed.</p></div><div><h3>Results</h3><p>Treatment-emergent adverse events up to 21<!--> <!-->days after vaccination were reported by 583 of 4746 subjects (12.3%), most commonly headache. Overall, 2318 of 6825 subjects (34.0%) recorded local reactions (most commonly tenderness and pain on slightest pressure) and 1229 of 6825 subjects (18.2%) recorded systemic reactions (most commonly headache and fatigue). All local and systemic reactions were mild or moderate and resolved in 1–2<!--> <!-->days. Most subjects in each population group reported inconvenience as none-to-mild. Post marketing surveillance data collected from 1982 to 2012 indicated an overall reporting rate of 24.5 events/million doses. The age-specific CHMP serological criteria for immunogenicity were generally met in all the adult and elderly populations and the HI antibody titres and derived serological parameters in children were similar to those in adults. The CHMP requirement for immunogenicity for annual re-licensing for both healthy adults and elderly subjects was consistently met over the 30-year period. One study in elderly subjects demonstrated that HI antibody titres were maintained at relatively high levels for at least 6<!--> <!-->months, providing coverage throughout the influenza season, but by 1<!--> <!-->year after vaccination antibody titres had declined to low enough levels to necessitate revaccination.</p></div><div><h3>Conclusions</h3><p>This review of the 30-year clinical experience with Influvac® found that the overall benefit-to-risk ratio is positive for all age groups from 6<!--> <!-->months upwards. The currently available evidence from the many clinical trials that have been performed confirms that Influvac® remains an effective and safe vaccine for preventing seasonal inf","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 42-48"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2012.10.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638820","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-08-25DOI: 10.1016/j.trivac.2012.07.001
Rosalind Rowland , Nathaniel Brittain , Ian D Poulton , Angela M Minassian , Clare Sander , David W Porter , Nicola Williams , Iman Satti , Ansar A Pathan , Alison M Lawrie , Helen McShane
{"title":"A review of the tolerability of the candidate TB vaccine, MVA85A compared with BCG and Yellow Fever vaccines, and correlation between MVA85A vaccine reactogenicity and cellular immunogenicity","authors":"Rosalind Rowland , Nathaniel Brittain , Ian D Poulton , Angela M Minassian , Clare Sander , David W Porter , Nicola Williams , Iman Satti , Ansar A Pathan , Alison M Lawrie , Helen McShane","doi":"10.1016/j.trivac.2012.07.001","DOIUrl":"10.1016/j.trivac.2012.07.001","url":null,"abstract":"<div><h3>Background</h3><p>The development of a new, more effective vaccine against tuberculosis (TB) for use in healthy and HIV-infected adults, children and infants, remains a global health priority. MVA85A is a candidate tuberculosis vaccine designed to enhance immunity to the existing vaccine, Bacillus Calmette-Guerin (BCG). MVA85A entered clinical trials in 2002 and has now progressed to Phase IIb proof-of-concept efficacy trials in infants and HIV-infected adults in Africa.</p></div><div><h3>Methods</h3><p>A detailed analysis was conducted of the cumulative safety data of intradermal delivery of MVA85A in 112 healthy adult subjects in a series of open label, single arm, non-controlled, Phase I safety and immunogenicity clinical trials in the UK. The trials differed with respect to previous mycobacterial exposure, vaccine regime and dose. Objective safety measures (local reaction size and body temperature) were evaluated for correlations with adaptive antigen-specific immune responses.</p></div><div><h3>Results</h3><p>All subjects in the combined mid-dose group developed a local reaction, of which 92% were mild, 8% were moderate and no reactions were severe. Around 90% of subjects in each group reported at least one systemic adverse event, most commonly headache, myalgia, malaise, feeling feverish, fatigue and arthralgia. Of all systemic adverse events in the combined mid-dose group, 96% were mild, 3% were moderate and 1% were severe (but none of these were judged to be vaccine-related). Pre-vaccination mycobacterial exposure did not affect the adverse event profile. The size of local reaction and frequency of systemic adverse events increased with MVA85A vaccine dose. There were no documented fevers in the low-dose group, whilst 3% of subjects in the combined mid-dose group and 21% in the high-dose group had documented fevers. Peak local reactions were larger after a second poxvirus vaccination, but other local and systemic adverse events were comparable to a single MVA85A vaccination. No severe systemic AEs or serious adverse events in any group were judged to be vaccine-related. Local AEs compared favourably to BCG vaccine-induced local AE and systemic AEs after MVA85A vaccination were comparable to those after the live viral Yellow Fever vaccine in similar populations. There were no correlations found between local reaction size or body temperature and adaptive immune responses (measured by <em>ex vivo</em> interferon gamma Enzyme Linked Immunospot).</p></div><div><h3>Conclusions</h3><p>The candidate TB vaccine, MVA85A has been safely administered to over 100 healthy adults in the UK. Intradermal vaccination with MVA85A induced a transient, superficial reaction local to the injection site and mild short-lived viral symptoms. The local and systemic AE profile of MVA85A vaccination was comparable to published data of other intradermal vaccines and live viral vaccines respectively. Local reaction sizes and body temperature measurements did ","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 27-35"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2012.07.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638751","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-08-25DOI: 10.1016/j.trivac.2012.07.002
Alexandre C. Linhares , Mercedes Macias-Parra , Xavier Sáez-Llorens , Rodrigo Vergara , Elias Jimenez , F. Raúl Velázquez , Yolanda Cervantes , Héctor José Abate , Luis Rivera , Ricardo Ruttimann , Doris Maribel Rivera-Medina , Belén Salinas , Eduardo Ortega-Barria , Pilar Rubio , Thomas B. Breuer
{"title":"Rotavirus gastroenteritis in Latin America: A hospital-based study in children under 3 years of age","authors":"Alexandre C. Linhares , Mercedes Macias-Parra , Xavier Sáez-Llorens , Rodrigo Vergara , Elias Jimenez , F. Raúl Velázquez , Yolanda Cervantes , Héctor José Abate , Luis Rivera , Ricardo Ruttimann , Doris Maribel Rivera-Medina , Belén Salinas , Eduardo Ortega-Barria , Pilar Rubio , Thomas B. Breuer","doi":"10.1016/j.trivac.2012.07.002","DOIUrl":"10.1016/j.trivac.2012.07.002","url":null,"abstract":"<div><p>Rotavirus is the leading cause of severe diarrheal disease and dehydration in infants in both developed and developing countries. Vaccines have recently been developed, but detailed epidemiological information, which is needed for decisions about how and where to introduce vaccination, was lacking for many Latin American countries. The primary objective of this study was to measure the incidence and disease burden of rotavirus in young children presenting to Latin American hospitals with gastroenteritis. In addition it allowed to setting up the methodology to further conduct a large phase III trial with a rotavirus vaccine in the region. This was a prospective, multi-center surveillance study of gastroenteritis in children <3<!--> <!-->years old presenting to hospitals in 11 Latin American countries. Questionnaires and stool samples were collected from 6521 of 8031 enrolled cases (73% inpatients). Among these, 3122 (49%) were rotavirus positive. Of the rotavirus-positive cases, 12% were <6<!--> <!-->months, 48% <1<!--> <!-->year and 87% <2<!--> <!-->years old; 23% received antibiotics before diagnosis. Median hospital stay was 2<!--> <!-->days, 78% received intravenous rehydration. Overall strain distribution was G1 (59%), G2 (1%), G3 (12%), G4 (20%), G9 (6%), G12 (1%), untypable (7%) with large local variations. The direct economic impact on families was considerable: 48% of caregivers lost time from paid work and 69% of families were financially affected by their child's illness. This study confirms the high disease burden of rotavirus gastroenteritis among children in Latin America, which might be reduced by the use of effective vaccines.</p></div>","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 36-41"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2012.07.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638792","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-03-22DOI: 10.1016/j.trivac.2011.12.001
Ray Spier (Editor-in-chief, Trials in Vaccinology)
{"title":"Welcome Editorial to Trials in Vaccinology","authors":"Ray Spier (Editor-in-chief, Trials in Vaccinology)","doi":"10.1016/j.trivac.2011.12.001","DOIUrl":"10.1016/j.trivac.2011.12.001","url":null,"abstract":"","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 2-3"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2011.12.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"94603124","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Trials in vaccinologyPub Date : 2012-01-01Epub Date: 2012-03-22DOI: 10.1016/j.trivac.2011.12.002
Alessilva Oliveira , Joana D’Arc P. Mascarenhas , Luana S. Soares , Sylvia F.S. Guerra , Yvone B. Gabbay , Nervo Sánchez , Romulo E. Colindres , Maria Cleonice A. Justino , Alexandre C. Linhares
{"title":"Rotavirus serotype distribution in northern Brazil trends over a 27 year period pre and post national vaccine introduction","authors":"Alessilva Oliveira , Joana D’Arc P. Mascarenhas , Luana S. Soares , Sylvia F.S. Guerra , Yvone B. Gabbay , Nervo Sánchez , Romulo E. Colindres , Maria Cleonice A. Justino , Alexandre C. Linhares","doi":"10.1016/j.trivac.2011.12.002","DOIUrl":"10.1016/j.trivac.2011.12.002","url":null,"abstract":"<div><p>In Brazil, a rotavirus vaccine was included in the public sector in March 2006. In order to identify a possible effect of vaccination on rotavirus strains we evaluated the distribution of serotypes/genotypes in northern Brazil during pre (1981–2005) and early post (2006–2008) national rotavirus vaccine introduction periods. Of 1286 rotavirus strains, 993 (77.2%) were successfully G typed. G1 strains were detected throughout the years, accounting for the majority of typed isolates (<em>n</em> <!-->=<!--> <!-->426; 42.9%). G2 rotaviruses displayed a cyclic pattern of occurrence over time, re-emerging recently in early 2006, with detection rates as high as 91%, and remained the predominant circulating strain through 2008. G9 rotaviruses appeared during 1990–1992, re-emerged from 1998 to 2000 and rose to 43% in a gastroenteritis outbreak in north-western Brazil in 2005. The most common combinations overall were G2P[4] (55.1%; 136/247), and G1P[8] (24.7%; 61/247). Although our data show the predominance of G2P[4] early after vaccine introduction, there is a need for continuous, long-term surveillance of circulating strains to better assess a possible effect of rotavirus vaccination on the strain ecology.</p></div>","PeriodicalId":90075,"journal":{"name":"Trials in vaccinology","volume":"1 ","pages":"Pages 4-9"},"PeriodicalIF":0.0,"publicationDate":"2012-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.trivac.2011.12.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"55638605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}