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Association between Vaginal Infection and Cervical Non-HPV16/18 Infection in Women after Bivalent HPV Vaccination

Association between Vaginal Infection and Cervical Non-HPV16/18 Infection in Women after Bivalent HPV Vaccination

Fanghui Zhao

Cancer Hospital, Chinese Academy of Medical Sciences

28 February 2020

Human papillomavirus (HPV) is one of the most common sexually transmitted diseases. More than 40 HPV genotypes could be spread through sexual contact and infect the anus and genitals. Those HPV types fall into two groups, high risk and low risk. Persistent High-risk HPV infection can cause almost all cervical cancer cases. There are about 14 high-risk HPV types. Two of these, HPV16 and HPV18, are responsible for about 70% of cervical cancers. While, low-risk HPVs can cause genital warts. However, only a small percentage of cervical HPV infections persists and even progresses to invasive cervical cancer due to the differences in immune responses to HPV and exogenous cofactors, such as smoking, oral contraceptive, parity and other sexual transmitted infections. Currently, the role of vaginal infection (the most common types are bacterial vaginosis, Candida spp. and Trichomonas vaginalis) as a cofactor in cervical carcinogenesis is not well established, and existing epidemiological studies typically use cross-sectional or case-control study approaches and have shown inconsistent results.Moreover, HPV16/18 vaccines have the potential to vastly reduce the incidence of HPV16/18 infections and related cervical cancers. Yet, among HPV vaccinated women, the proportion of cervical cancer caused by non-vaccine HPV types will eventually dominate after a duration of widespread implementation of HPV vaccination. Furthermore, non-HPV16/18 types may need a much stronger push from cofactors to remain persistent infection status since they are the less carcinogenic types compared to HPV16/18. Thus, we propose to perform a post-hoc analysis using data from GSK-107638 to assess the association between vaginal infection and non-HPV16/18 infection (including incident and 6-month persistent HPV infections) from a prospective aspect.

[{ "PostingID": 2794, "Title": "GSK-107638", "Description": "Efficacy, immunogenicity and safety of GlaxoSmithKline Biologicals’ HPV GSK 580299 vaccine in healthy Chinese female subjects" }]

Statistical Analysis Plan

Shang-Ying Hu, Sabrina H Tsang, Feng Chen, Qin-Jing Pan, Wen-Hua Zhang, Ying Hong, Joshua N Sampson, Allan Hildesheim, Fang-Hui Zhao, Aimée R Kreimer, Association Between Common Vaginal Infections and Cervical Non-Human Papillomavirus (HPV) 16/18 Infection in HPV-Vaccinated Women, The Journal of Infectious Diseases, Volume 223, Issue 3, 1 February 2021, Pages 445-451