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).
Main Authors: | , , , , , , , , , , |
---|---|
Format: | Digital revista |
Language: | English |
Published: |
Instituto de Medicina Tropical de São Paulo
2018
|
Online Access: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0036-46652018005000222 |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
id |
oai:scielo:S0036-46652018005000222 |
---|---|
record_format |
ojs |
spelling |
oai:scielo:S0036-466520180050002222018-07-25Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto ButantanMondini,GabriellaBraga,Patricia EmiliaLopes,Marta HeloisaSartori,Ana Marli ChristovamMiyaji,Karina TakesakiInfante,VanessaRandi,Bruno AzevedoTimenetsky,Maria do Carmo Sampaio TavaresFerreira,Juliana Caires de Oliveira AchiliSakita,Neusa KeicoPrecioso,Alexander Roberto Seasonal influenza vaccine Vaccine immunogenicity Vaccine safety Cohort studies Adults Elderly 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).info:eu-repo/semantics/openAccessInstituto de Medicina Tropical de São PauloRevista do Instituto de Medicina Tropical de São Paulo v.60 20182018-01-01info:eu-repo/semantics/articletext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0036-46652018005000222en10.1590/s1678-9946201860037 |
institution |
SCIELO |
collection |
OJS |
country |
Brasil |
countrycode |
BR |
component |
Revista |
access |
En linea |
databasecode |
rev-scielo-br |
tag |
revista |
region |
America del Sur |
libraryname |
SciELO |
language |
English |
format |
Digital |
author |
Mondini,Gabriella Braga,Patricia Emilia Lopes,Marta Heloisa Sartori,Ana Marli Christovam Miyaji,Karina Takesaki Infante,Vanessa Randi,Bruno Azevedo Timenetsky,Maria do Carmo Sampaio Tavares Ferreira,Juliana Caires de Oliveira Achili Sakita,Neusa Keico Precioso,Alexander Roberto |
spellingShingle |
Mondini,Gabriella Braga,Patricia Emilia Lopes,Marta Heloisa Sartori,Ana Marli Christovam Miyaji,Karina Takesaki Infante,Vanessa Randi,Bruno Azevedo Timenetsky,Maria do Carmo Sampaio Tavares Ferreira,Juliana Caires de Oliveira Achili Sakita,Neusa Keico Precioso,Alexander Roberto Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
author_facet |
Mondini,Gabriella Braga,Patricia Emilia Lopes,Marta Heloisa Sartori,Ana Marli Christovam Miyaji,Karina Takesaki Infante,Vanessa Randi,Bruno Azevedo Timenetsky,Maria do Carmo Sampaio Tavares Ferreira,Juliana Caires de Oliveira Achili Sakita,Neusa Keico Precioso,Alexander Roberto |
author_sort |
Mondini,Gabriella |
title |
Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
title_short |
Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
title_full |
Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
title_fullStr |
Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
title_full_unstemmed |
Prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by Instituto Butantan |
title_sort |
prospective cohort studies to evaluate the safety and immunogenicity of the 2013, 2014, and 2015 seasonal influenza vaccines produced by instituto butantan |
description |
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). |
publisher |
Instituto de Medicina Tropical de São Paulo |
publishDate |
2018 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0036-46652018005000222 |
work_keys_str_mv |
AT mondinigabriella prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT bragapatriciaemilia prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT lopesmartaheloisa prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT sartorianamarlichristovam prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT miyajikarinatakesaki prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT infantevanessa prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT randibrunoazevedo prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT timenetskymariadocarmosampaiotavares prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT ferreirajulianacairesdeoliveiraachili prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT sakitaneusakeico prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan AT preciosoalexanderroberto prospectivecohortstudiestoevaluatethesafetyandimmunogenicityofthe20132014and2015seasonalinfluenzavaccinesproducedbyinstitutobutantan |
_version_ |
1756379938137571328 |