Department of Obstetrics & Gynaecology, Fundación Santa Fe de Bogotá, Bogotá, Colombia.
Department of Gynaecology, Fundación Cardioinfantil, Bogotá, Colombia.
Hum Vaccin Immunother. 2022 Nov 30;18(5):2078626. doi: 10.1080/21645515.2022.2078626. Epub 2022 Jul 19.
Among women aged 27-45 years, the quadrivalent human papillomavirus (qHPV; HPV6/11/16/18) vaccine was generally well tolerated, efficacious, and immunogenic in the placebo-controlled FUTURE III study (NCT00090220; n = 3253). The qHPV vaccine was also generally well tolerated and highly immunogenic in men aged 27-45 years who participated in the single-cohort mid-adult male (MAM) study (NCT01432574; n = 150). Here, we report results of a long-term follow up (LTFU) extension of FUTURE III with up to 10 years follow-up. To understand the relevance of the mid-adult women LTFU study in the context of mid-adult men vaccination, we report results from post-hoc, cross-study immunogenicity analyses conducted to compare immunogenicity (geometric mean titers; GMTs) at 1-month post-qHPV vaccine dose 3 in women and men aged 27-45 years versus women and men aged 16-26 years from prior efficacy studies. The qHPV vaccine demonstrated durable protection against the combined endpoint of HPV6/11/16/18-related high-grade cervical dysplasia and genital warts up to 10 years (median 8.9) post-dose 3 and sustained HPV6/11/16/18 antibody responses through approximately 10 years in women aged 27-45 years. Efficacy of qHPV vaccine in men aged 27-45 years was inferred based on the cross-study analysis of qHPV vaccine immunogenicity demonstrating non-inferior HPV6/11/16/18 antibody responses in men aged 27-45 years versus 16-26 years. In conclusion, durable effectiveness of the qHPV vaccine was demonstrated in women 27-45 years of age, and vaccine efficacy was inferred in men 27-45 years of age based on the serological results.
在 27-45 岁的女性中，四价人乳头瘤病毒（qHPV；HPV6/11/16/18）疫苗在安慰剂对照的 FUTURE III 研究（NCT00090220；n=3253）中总体具有良好的耐受性、疗效和免疫原性。在参加单队列中年男性（MAM）研究（NCT01432574；n=150）的 27-45 岁男性中，qHPV 疫苗也具有良好的耐受性和高度的免疫原性。在这里，我们报告了 FUTURE III 的长期随访（LTFU）扩展的结果，随访时间长达 10 年。为了了解中年女性 LTFU 研究在中年男性接种疫苗方面的相关性，我们报告了事后、跨研究免疫原性分析的结果，该分析旨在比较 27-45 岁女性和男性与 16-26 岁女性和男性在接受 qHPV 疫苗第 3 剂后 1 个月的免疫原性（几何平均滴度；GMTs）。qHPV 疫苗在接受第 3 剂 qHPV 疫苗后长达 10 年（中位 8.9 年）时，对 HPV6/11/16/18 相关高级别宫颈发育不良和生殖器疣的联合终点提供了持久的保护，并且在 27-45 岁的女性中，HPV6/11/16/18 抗体反应可持续至约 10 年。27-45 岁男性的 qHPV 疫苗疗效是基于对 qHPV 疫苗免疫原性的跨研究分析推断得出的，该分析表明，27-45 岁男性与 16-26 岁男性的 HPV6/11/16/18 抗体反应无差异。总之，qHPV 疫苗在 27-45 岁的女性中表现出持久的有效性，并且基于血清学结果，在 27-45 岁的男性中推断出了疫苗的疗效。
