Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study

Vaccine
Hiroshige MikamoYoshiyuki Tanaka

Abstract

The quadrivalent (q) human papillomavirus (HPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, and 18. We report efficacy, immunogenicity, and safety of qHPV vaccine in a Phase 3 study in Japanese men. In this randomized, double-blind trial (NCT01862874), Japanese men (aged 16-26 years) were randomized in a 1:1 ratio to receive three doses of qHPV vaccine or placebo (Day 1, Month 2, Month 6). The primary efficacy endpoint was the combined incidence of HPV6/11/16/18-related persistent anogenital infection (detected at ≥2 consecutive visits ≥6 months apart), assessed in the per-protocol population of men who received all three vaccinations, and were seronegative at Day 1 and PCR negative from Day 1 to Month 7 to the relevant HPV type. Results are from the interim and final analyses. In total, 1124 participants were randomized. The vaccine demonstrated 83.3% (95% confidence interval: 24.9, 98.2; p = 0.007) and 85.9% (95% confidence interval: 52.7, 97.3; p < 0.001) efficacy against HPV6/11/16/18-related persistent infection in the interim and final analyses, respectively. Two cases of HPV6/11/16/18-related external genital lesions (condyloma and PIN 1) were observed in the placebo group and none in t...Continue Reading

Citations

May 18, 2019·The Journal of Infectious Diseases·Petra J WoestenbergUNKNOWN Medical Microbiological Laboratories and the Public Health Services
Dec 21, 2019·Revista Do Instituto De Medicina Tropical De São Paulo·Miriam da Silva WanderleyNathália Regina Cardoso Aragão
May 29, 2020·BMC Public Health·Anita LukácsAndrea Szabó
Oct 2, 2021·Experimental and Therapeutic Medicine·Arsenie Dan SpînuDan Liviu Dorel Mischianu

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