Dataset Information

Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan.

ABSTRACT: Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection followed by vaccination. On study days 1, 2 and 3 post-vaccination participants were contacted by the staff to evaluate the occurrence of solicited (local and systemic) and non-solicited adverse reactions. On study day 21 (+7) subjects returned to the clinical site for final safety assessments and blood collection to evaluate post-vaccination immunogenicity. The immunogenicity analyses were performed by means of hemagglutination inhibition (HI) assay. The immunogenicity endpoints were: seroprotection (SPR) and seroconversion (SCR) rates and the geometric mean HI antibody titer ratio (GMTR). The 2013 study was conducted at the Centro de Referência para Imunobiológicos Especiais (CRIE) and at the Centro de Pesquisa Clínica do Instituto da Criança, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo while the 2014 and 2015 studies were conducted at CRIE. The vaccine composition followed the WHO recommendation for the Southern hemisphere seasonal influenza vaccine. Forty-seven healthy adults and 13 elderly participated in the 2013 study, 60 healthy adults and 60 elderly in the 2014 study, and 62 healthy adults and 57 elderly in the 2015 study. In the 2013, 2014 and 2015 studies, pain was the most frequent local adverse reaction and headache the most frequent systemic adverse reaction. All observed adverse reactions were classified as mild or moderate and none as severe. SPR >70% and SPR >60% were observed in adults and elderly, respectively, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. SCR >40% was observed in adults, for the three vaccine viruses, only in the 2014 study and SCR >30% was observed in the elderly, for the three vaccine viruses, only in the 2013 and 2014 studies. GMTR >2.5 among adults, for the three vaccine viruses was only observed in the 2013 study and GMTR >2.0 was observed among elderly, for the three vaccine viruses, in the 2013, 2014 and 2015 studies. The 2013, 2014 and 2015 seasonal influenza vaccines produced by Instituto Butantan were safe and immunogenic according to the immunogenicity criteria defined by the European Medicines Agency (EMA).

SUBMITTER: Mondini G

PROVIDER: S-EPMC6069271 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan.

Mondini Gabriella G Braga Patricia Emilia PE Lopes Marta Heloisa MH Sartori Ana Marli Christovam AMC Miyaji Karina Takesaki KT Infante Vanessa V Randi Bruno Azevedo BA Timenetsky Maria do Carmo Sampaio Tavares MDCST Ferreira Juliana Caires de Oliveira Achili JCOA Sakita Neusa Keico NK Precioso Alexander Roberto AR

Revista do Instituto de Medicina Tropical de Sao Paulo 20180730

Annual vaccination is the most effective way to prevent seasonal influenza illness. Instituto Butantan (IB) performed clinical studies with its 2013, 2014 and 2015 seasonal trivalent influenza vaccines (inactivated split-virion). Prospective cohort studies were carried out to describe the safety and immunogenicity of Instituto Butantan influenza vaccines, in healthy adults and elderly, from 2013 to 2015. Immediately after the informed consent was signed, participants underwent blood collection f ...[more]

PMID: 30066805

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Project description:IntroductionActive pharmacovigilance studies are pivotal to better characterize vaccine safety.MethodsThese are multicenter prospective cohort studies to evaluate the safety of the 2017 and 2018 seasonal trivalent influenza vaccines (TIVs) manufactured by Instituto Butantan, by means of active pharmacovigilance practices. Elderly, children, healthcare workers, pregnant women, and women in the puerperium period were invited to participate in the study during the 2017 and 2018 Brazilian national seasonal influenza vaccination campaigns. Following immunization, participants were observed for 30 minutes and they received a participant card to register adverse events information. All safety information registered were checked at a clinical site visit 14 days after immunization and by a telephone contact 42 days after immunization for unsolicited Adverse Events (AE) and Guillain-Barré Syndrome (GBS).ResultsA total of 942 volunteers participated in the two studies: 305 elderly, 109 children, 108 pregnant women, 32 women in the postpartum period, and 388 health workers. Overall, the median number of AR per participant ranged from 1 to 4. The lowest median number of AR per participant was observed among healthcare workers (1 AR per participant) and the highest among pregnant women (4 AR per participant). Overall, local pain (46.6%) was the most frequent solicited local AR. The most frequent systemic ARs were: headache (22.5%) followed by fatigue (16.0%), and malaise (11.0%). The majority of solicited ARs (96%) were mild, Grades 1 or 2), only 3% were Grade 3, and 1% was Grade 4. No serious AEs, including Guillain-Barré Syndrome, were reported up to 42 days postvaccination.ConclusionThe results from the two studies confirmed that the 2017 and 2018 seasonal trivalent influenza vaccines produced by Instituto Butantan were safe and that active pharmacovigilance studies should be considered, when it is feasible, as an important initiative to monitor vaccine safety in the post-marketing period.

Project description:ObjectiveTo assess changes in engagement with online tobacco and electronic cigarette (e-cigarette) marketing (online tobacco marketing) among adolescents in the United States between 2013 and 2015.MethodsWe assessed the prevalence of six forms of engagement with online tobacco marketing, both overall and by brand, among adolescents sampled in Wave 1 (2013-2014; n = 13651) and Wave 2 (2014-2015; n = 12172) of the nationally representative Population Assessment for Tobacco and Health Study. Engagement was analyzed by tobacco use status: non-susceptible never tobacco users; susceptible never tobacco users; ever tobacco users, but not within the past year; and past-year tobacco users.ResultsAmong all adolescents, the estimated prevalence of engagement with at least one form of online tobacco marketing increased from 8.7% in 2013-2014 to 20.9% in 2014-2015. The estimated prevalence of engagement also increased over time across all tobacco use statuses (eg, from 10.5% to 26.6% among susceptible adolescents). Brand-specific engagement increased over time for cigarette, cigar, and e-cigarette brands.ConclusionEngagement with online tobacco marketing, both for tobacco and e-cigarettes, increased almost twofold over time. This increase emphasizes the dynamic nature of online tobacco marketing and its ability to reach youth. The Food and Drug Administration, in cooperation with social networking sites, should consider new approaches to regulate this novel form of marketing.ImplicationsThis is the first study to estimate the national prevalence of engagement with online tobacco marketing among adolescents over time. The estimated prevalence of this engagement approximately doubled between 2013-2014 and 2014-2015 among all adolescents and, notably, among adolescents at relatively low risk to initiate tobacco use. This increase in engagement could represent public health harm if it results in increased initiation and use of tobacco products. Stronger federal regulation of online tobacco marketing and tighter control of access to tobacco-related content by social media sites could reduce adolescents' exposure to and engagement with online tobacco marketing.

Dataset Information

Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan.

Publications

Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan.

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