A 9vHPV GCK 1026 dose formulation was selected in Phase II studies conducted in 16–26-year-old women based on the induction of non-inferior anti-HPV 6/11/16/18 antibody responses compared with qHPV vaccine [16]. This result was confirmed in Phase III studies in 16–26-year-old women and 9–15-year-old girls [10] and [15]. A similar analysis in 9–15-year-old boys was not deemed necessary because the immunogenicity of 9vHPV vaccine and qHPV vaccine are similar in 9–15-year-old boys and girls [17] and [18], and the two vaccines have similar immunogenicity in 9–15-year-old girls [15]. The current study demonstrates non-inferior anti-HPV 6/11/16/18 antibody responses in 16–26-year-old men. Collectively, these results support the conclusion that in males and females aged 9–26 years, 9vHPV vaccine and qHPV vaccine have similar immunogenicity profiles with respect to HPV 6/11/16/18.
Our study was conducted in heterosexual men (HM): the immunogenicity of HPV vaccines is lower in MSM than in HM [11] and [20]. Therefore, analyses of HPV vaccine immunogenicity should be conducted separately in HM and MSM. The immunogenicity of 9vHPV vaccine and qHPV vaccine in HM and MSM were extensively assessed in previous studies; the GMT ratios between HM and MSM were found to be similar with 9vHPV vaccine and qHPV vaccine [11] and [20]. Thus it was not deemed necessary to conduct an assessment of immunogenicity in MSM in this study.
Our study was conducted in heterosexual men (HM): the immunogenicity of HPV vaccines is lower in MSM than in HM [11] and [20]. Therefore, analyses of HPV vaccine immunogenicity should be conducted separately in HM and MSM. The immunogenicity of 9vHPV vaccine and qHPV vaccine in HM and MSM were extensively assessed in previous studies; the GMT ratios between HM and MSM were found to be similar with 9vHPV vaccine and qHPV vaccine [11] and [20]. Thus it was not deemed necessary to conduct an assessment of immunogenicity in MSM in this study.