| Author | Sternberg, Ángela María Ruiz | |
| Author | Moreira Junior, Edson Duarte | |
| Author | Restrepo, Jaime A. | |
| Author | Ponce, Eduardo Lazcano | |
| Author | Cabello, Robinson | |
| Author | Silva, Arnaldo | |
| Author | Andrade, Rosires | |
| Author | Revollo, Francisco | |
| Author | Uscanga, Santos | |
| Author | Victoria, Alejandro | |
| Author | Guevara, Ana María | |
| Author | Luna, Joaquín | |
| Author | Plata, Manuel | |
| Author | Dominguez, Claudia Nossa | |
| Author | Fedrizzi, Edison | |
| Author | Suarez, Eugenio | |
| Author | Reina, Julio C. | |
| Author | Ellison, Misoo C. | |
| Author | Moeller, Erin | |
| Author | Ritter, Michael | |
| Author | Shields, Christine | |
| Author | Cashat, Miguel | |
| Author | Perez, Gonzalo | |
| Author | Luxembourg, Alain | |
| Access date | 2018-05-15T12:46:02Z | |
| Available date | 2018-05-15T12:46:02Z | |
| Document date | 2018 | |
| Citation | STEMBERG, Ángela María Ruiz et al. Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women. Papillomavirus Research, v. 5, p. 1-12, 2018. | pt_BR |
| ISSN | 2405-8521 | pt_BR |
| URI | https://www.arca.fiocruz.br/handle/icict/26442 | |
| Description | Moreira Junior, Edson Duarte. Associação Obras Sociais Irmã Dulce / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil. a Clinical Research Group, Universidad del Rosario, Bogotá, Colombia
b Associação Obras Sociais Irmã Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil
c Foundation Clinical Research Center CIC, Medellín, Colombia
d Research Center on Public Health, National Institute of Public Health, Cuernavaca, Morelos, Mexico
e Via Libre Association, Lima, Peru
f Hospital Nacional Arzobispo Loayza, Lima, Peru
g Departamento de Tocoginecologia da Universidade Federal do Paraná, Curitiba, Brazil
h Centro de Investigaciones, Hospital Universitario San Ignacio, Bogotá, Colombia
i Arké Estudios Clínicos S.A. de C.V., Mexico City, Mexico
j Department of Obstetrics and Gynecology, Fundacion Valle del Lili, Cali, Colombia
k Research Unit, Pablo Tobon Uribe Hospital, Medellin, Colombia
l Departamento de Ginecología y Obstetricia Clínica Colsanitas, Fundación Universitaria Sanitas, Bogotá, Colombia
mDepartment of Gynecology, Fundación Cardioinfantil, Bogotá, Colombia
n CAFAM, Bogotá, Colombia
o Department of Gynecology and Obstetrics, University of Santa Catarina, Florianópolis, Santa Catarina, Brazil
p Gynecological Oncology Division Hospital Clinico San Borja Arriaran Universidad de Chile Campus Centro, Santiago, Chile
q Department of Pediatrics, Universidad del Valle and Centro Medico Imbanaco, Cali, Colombia
r Merck & Co., Inc., Kenilworth, NJ, USA | pt_BR |
| Sponsorship | Merck & Co., Inc., Kenilworth, NJ, USA | pt_BR |
| Language | eng | pt_BR |
| Publisher | Elsevier | pt_BR |
| Rights | open access | pt_BR |
| Title | Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1016/j.pvr.2017.12.004 | |
| Abstract | A 9-valent human papillomavirus (HPV6/11/16/18/31/33/45/52/58; 9vHPV) vaccine was developed to expand coverage of the previously developed quadrivalent (HPV6/11/16/18; qHPV) vaccine. Methods: Efficacy, immunogenicity, and safety outcomes were assessed in Latin American participants enrolled
in 2 international studies of the 9vHPV vaccine, including a randomized, double-blinded, controlled with qHPV
vaccine, efficacy, immunogenicity, and safety study in young women aged 16–26 years, and an immunogenicity
and safety study in girls and boys aged 9–15 years. Participants (N=5312) received vaccination at Day 1, Month
2, and Month 6. Gynecological swabs were collected regularly in young women for cytological and HPV DNA
testing. Serum was analyzed for HPV antibodies in all participants. Adverse events (AEs) were also monitored in
all participants.
Results: The 9vHPV vaccine prevented HPV 31-, 33-, 45-, 52-, and 58-related high-grade cervical, vulvar, and
vaginal dysplasia with 92.3% efficacy (95% confidence interval 54.4, 99.6). Anti-HPV6, 11, 16, and 18 geometric
mean titers at Month 7 were similar in the 9vHPV and qHPV vaccination groups. Anti-HPV antibody
responses following vaccination were higher among girls and boys than in young women. Most (> 99%) 9vHPV
vaccine recipients seroconverted for all 9 HPV types at Month 7. Antibody responses to the 9 HPV types persisted over 5 years. The most common AEs were injection-site related, mostly of mild to moderate intensity.
Conclusions: The 9vHPV vaccine is efficacious, immunogenic, and well tolerated in Latin American young
women, girls, and boys. These data support 9vHPV vaccination programs in Latin America, a region with
substantial cervical cancer burden. | pt_BR |
| Affilliation | Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil. | pt_BR |
| Affilliation | Múltipla - ver em Notas | pt_BR |
| Subject | Human papillomavirus | pt_BR |
| Subject | Vaccine | pt_BR |
| Subject | Cervical cancer | pt_BR |
| Subject | Persistent infection | pt_BR |
| Subject | 9vHPV | pt_BR |
| xmlui.metadata.dc.subject.ods | 03 Saúde e Bem-Estar | |
