Efficacy, immunogenicity, and safety of a 9-valent human papillomavirus vaccine in Latin American girls, boys, and young women

Abstract

BackgroundA 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.MethodsEfficacy, 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.ResultsThe 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.ConclusionsThe 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.

Long intervals between two doses of HPV vaccines and magnitude of the immune response: a post hoc analysis of two clinical trials

“…One month post second dose of HPV9 of immunogenicity of 4vHPV and 9vHPV vaccine in Latin American young females, which show higher anti-HPV18 GMTs in subjects who received the 9vHPV when compared to 4vHPV vaccine. 14 The higher antibody titers after 9vHPV vaccine but similar fold increase post second dose in our studies suggest a stronger priming to HPV18 is induced by the first dose of this vaccine when compared to 4vHPV. The anti-HPV16 GMTs were slightly higher in subjects who received two different vaccines (all p > .05).…”

The burden of 14 hr-HPV genotypes in women attending routine cervical cancer screening in 20 states of Mexico: a cross-sectional study

“…However, these genotypes are not included in the current vaccines available in the country (Cevarix and Gardasil4). Recently, a nine-valent vaccine (Gardasil9) which immunizes against HPV 6/11/16/18/31/33/45/52/58 has been tested to assess their safety and efficacy to reduce precancerous lesions 41–43 and has been approved for use in Europe, Canada, Australia, and the US 44 . This vaccine immunizes against the most prevalent carcinogenic genotypes found in this work and other previous studies in the country, so that could be suitable for vaccination in Mexico.…”

Advances in Designing and Developing Vaccines, Drugs and Therapeutic Approaches to Counter Human Papilloma Virus

“…These HPV vaccine-related adverse effects (AEs) usually occur from day 1 to day 15 after vaccination and mostly are mild; the vaccines are believed to be well tolerated in girls, boys and young women ( 234 ). Nevertheless, serious HPV vaccine related AEs that required hospitalization occurred in vaccinees of 9-valent HPV vaccine including asthmatic attack in a 10-year-old boy who had experienced seasonal allergy and bronchial asthma; high fever (>38°C), body pain, headache, and malaise in a 26-year-old woman; and occipital headache with photophobia, nausia and chill in a 23-year-old woman ( 234 ). In a large cohort study of >2 million young girls (aged 13–16 years) between 2008 and 2012 in France of which 37% received HPV vaccine, autoimmune diseases (AID) occurred in 4,096 subjects during the follow-up time (mean of 33 months).…”