Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/25793
Type
ArticleCopyright
Open access
Sustainable Development Goals
03 Saúde e Bem-EstarCollections
Metadata
Show full item record
IMPACT OF BASELINE COVARIATES ON THE IMMUNOGENICITY OF THE 9-VALENT HPV VACCINE - A COMBINED ANALYSIS OF FIVE PHASE III CLINICAL TRIALS
9v Vacina contra o HPV
Imunogenicidade
Ensaio clínico
Author
Petersen, Lone K
Restrepo, Jaime
Moreira Junior, Edson Duarte
Iversen, Ole-Erik
Pitisuttithum, Punnee
Van Damme, Pierre
Joura, Elmar A
Olsson, Sven-Erik
Ferris, Daron
Block, Stan
Giuliano, Anna R
Bosch, Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Bautista, Oliver M
Hyatt, Donna
Maansson, Roger
Moeller, Erin
Qi, Hong
Roberts, Christine
Luxembourg, Alain
Restrepo, Jaime
Moreira Junior, Edson Duarte
Iversen, Ole-Erik
Pitisuttithum, Punnee
Van Damme, Pierre
Joura, Elmar A
Olsson, Sven-Erik
Ferris, Daron
Block, Stan
Giuliano, Anna R
Bosch, Xavier
Pils, Sophie
Cuzick, Jack
Garland, Suzanne M
Huh, Warner
Kjaer, Susanne K
Bautista, Oliver M
Hyatt, Donna
Maansson, Roger
Moeller, Erin
Qi, Hong
Roberts, Christine
Luxembourg, Alain
Affilliation
Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Múltipla – ver em Notas
Múltipla – ver em Notas
Abstract
The immunogenicity profile of the 9-valent HPV (9vHPV) vaccine was evaluated across five phase III clinical studies conducted in girls and boys 9-15 years of age and young women 16-26 years of age. The effect of baseline characteristics of subjects on vaccine-induced HPV antibody responses was assessed. Methods: Immunogenicity data from 11,304 subjects who received ≥1 dose of 9vHPV vaccine in five Phase III
studies were analyzed. Vaccine was administered as a 3-dose regimen. HPV antibody titers were assessed
1 month after dose 3 using a competitive Luminex immunoassay and summarized as geometric mean
titers (GMTs). Covariates examined were age, gender, race, region of residence, and HPV serostatus and PCR
status at day 1.
Results: GMTs to all 9 vaccine HPV types decreased with age at vaccination initiation, and were
otherwise generally similar among the demographic subgroups defined by gender, race and region of residence.
For all subgroups defined by race or region of residence, GMTs were higher in girls and boys than in young
women. Vaccination of subjects who were seropositive at day 1 to a vaccine HPV type resulted in higher GMTs
to that type, compared with those in subjects who were seronegative for that type at day 1.
Conclusions: 9vHPV vaccine immunogenicity was robust among subjects with differing baseline characteristics.
It was generally comparable across subjects of different races and from different regions. Greater immunogenicity
in girls and boys versus young women (the population used to establish 9vHPV vaccine efficacy in
clinical studies) indicates that the anti-HPV responses generated by the vaccine in adolescents from all races or regions were sufficient to induce high-level protective efficacy. This immunogenicity profile supports a
widespread 9vHPV vaccination program and early vaccination.
Keywords in Portuguese
Vírus do papiloma humano9v Vacina contra o HPV
Imunogenicidade
Ensaio clínico
Share