The 9-valent HPV vaccine (9vHPV vaccine) is comprised of VLPs of the 4 HPV types (Type 6, 11, 16, and 18) contained in the quadrivalent HPV (qHPV) vaccine, and VLPs of 5 additional oncogenic HPV types (Type 31, 33, 45, 52, and 58). In men, qHPV vaccine is indicated for the prevention of high grade anal-intrapithelial lesions, anal cancers and genital warts related to vaccine types.The objective of this study is to extend the efficacy findings observed with qHPV vaccine to 9vHPV vaccine by demonstrating that 9vHPV vaccine elicits non-inferior antibody responses compared to qHPV vaccine for HPV types 6/11/16/18 in men 16 to 26 years of age.
500 boys/men aged 16-26 years were randomized 1:1 to receive 9vHPV vaccine or qHPV vaccine, at Day 1, Month 2 and Month 6 (3 doses). Antibody responses were evaluated at Month 7 by competitive Luminex Immunoassay. Immunogenicity analyses were performed in the per-protocol population. Safety data were collected from Day 1 to Month 7.
The HPV 6/11/16/18 immune responses elicited by the 9vHPV and the qHPV vaccines were comparable and the non-inferiority of the 9vHPV vaccine compared to qHPV vaccine was demonstrated for all 4 types (lower bound of the two-sided 95% confidence interval around post-dose 3 GMT ratio (9vHPV/qHPV vaccine) greater than 0.5). All participants receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles.
The 9vHPV vaccine is well tolerated and elicits anti-HPV 6/11/16/18 that are non-inferior to those generated by the qHPV vaccine in 16-26 year-old men. These results support extending the efficacy findings with qHPV vaccine to 9vHPV vaccine in this population.