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Title: Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women
Authors: Sternberg, Ángela María Ruiz
Moreira Junior, Edson Duarte
Restrepo, Jaime A.
Ponce, Eduardo Lazcano
Cabello, Robinson
Silva, Arnaldo
Andrade, Rosires
Revollo, Francisco
Uscanga, Santos
Victoria, Alejandro
Guevara, Ana María
Luna, Joaquín
Plata, Manuel
Dominguez, Claudia Nossa
Fedrizzi, Edison
Suarez, Eugenio
Reina, Julio C.
Ellison, Misoo C.
Moeller, Erin
Ritter, Michael
Shields, Christine
Cashat, Miguel
Perez, Gonzalo
Luxembourg, Alain
Affilliation: Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil.
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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.
Keywords: Human papillomavirus
Cervical cancer
Persistent infection
Issue Date: 2018
Publisher: Elsevier
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.
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
DOI: 10.1016/j.pvr.2017.12.004
ISSN: 2405-8521
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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