Lancet Sub-Publication: Gender Equality - HPV Vaccination for Women Can Prevent Cancer, Men Are No Exception!

2021-12-07 Original by Dr. Apathy MedSci

The quadrivalent HPV vaccine provides durable protection against anogenital disease associated with HPV6, 11, 16 and 18. The results support the use of quadrivalent HPV vaccine in men, including catch-up vaccines.

To quantify the early impact of the immunization programme on cervical cancer and cervical carcinoma in situ, cervical intraepithelial neoplasia grade 3 (CIN3) registration, experts from the Cancer Prevention Group, King's College London, School of Cancer and Pharmaceutical Sciences, conducted research. , results showed that the introduction of the HPV immunisation programme in England almost eliminated cervical cancer in women born since 1 September 1995.

To assess the incidence of genital warts associated with HPV6 or 11, as well as genital lesions and anal cancer associated with HPV6, 11, 16, or 18, at 10 years of follow-up, from the Icahn School of Medicine at Mount Sinai in New York. Experts carried out the study and the results were published in the journal Lancet Infectious Disease.

The 3-year initial follow-up study was an international, multicenter, double-blind, randomized, placebo-controlled trial conducted at 71 sites in 18 countries. Eligible participants were heterosexual men (16-23 years) or men who had sex with men (MSM; 16-26 years). Eligible participants were randomly assigned (1:1) to receive three doses of the quadrivalent HPV vaccine or placebo on days 1, 2, and 6.

A 7-year, open-label, long-term follow-up extension study followed, conducted at 46 centers in 16 countries. Participants who received one or more doses of the quadrivalent HPV vaccine in the basic study were eligible for inclusion in the long-term follow-up study (early vaccination group). Placebo subjects received three doses of the quadrivalent HPV vaccine at the end of the basic study; those who received one or more doses of the quadrivalent HPV vaccine were eligible to enroll in the long-term follow-up study (revaccination group). The primary efficacy endpoints were the incidence of HPV6 or 11-related external genital warts and HPV6, 11, 16 or 18-related external genital warts in all participants, and HPV6, 11, 16 or 18 in MSM only. 18. Incidence of associated anal intraepithelial neoplasia (including anal warts and flat lesions) or anal cancer.

Between August 10, 2010, and April 3, 2017, 1803 participants were enrolled in the long-term follow-up study, of which 936 (827 heterosexual men and 109 MSM) were enrolled in the early vaccination group, and 867 (739 MSM) were enrolled in the early vaccination group. 128 heterosexual men and 128 MSM) were included in the reseeding group. During long-term follow-up, the incidence of external genital warts was 0.0 vs 137.3 per 10,000 person-years in the vaccine and placebo groups, and 20.5 vs 906.2 per 10,000 person-years for external genital lesions or anal intraepithelial neoplasia/anal cancer.

Participants in the catch-up vaccine group had no new reported cases of HPV6 or 11-related external genital warts during long-term follow-up compared with the basic study period (ie, before quadrivalent HPV vaccination) 0.0 vs 149.6/10,000 person-years , 0.0 vs 155/10,000 person-years for external genital lesions, and 101.3 vs 583.9/10,000 person-years for anal intraepithelial neoplasia or anal cancer, respectively.

In conclusion, the quadrivalent HPV vaccine provided durable protection against anogenital diseases associated with HPV6, 11, 16 and 18. The results support the use of quadrivalent HPV vaccine in men, including catch-up vaccines.

Reference：

Efficacy, immunogenicity, and safety of a quadrivalent HPV vaccine in men: results of an open-label, long-term extension of a randomised, placebo-controlled, phase 3 trial. https://doi.org/10.1016/S1473-3099(21)00327-3

The Human Papillomavirus Real Time PCR Kit is an in-vitro diagnostic (IVD) kit, based on real-time PCR technology, for the detection of 18 HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, 73, 53, 82, and 26) in cervical exfoliated cells in one reaction well. The kit identifies HPV16, HPV18, other HPV types and internal control (β-globin) using fluorescence channels: FAM, VIC, ROX and CY5. This kit contains primers and probes that are designed to target the L1, L2, and E1 genes of 18 HPV types. The amplicon length of each HPV type does not exceed 200 bp. A PCR fluorescence detection system is used to record the change in fluorescence emitted by the fluorescent probe at each PCR cycle during PCR amplification, which directly reflects the change in the PCR amplification yield.