Efficacy of the AS04-adjuvanted HPV-16/18 vaccine in young Chinese women with oncogenic HPV infection at baseline: post-hoc analysis of a randomized controlled trial

• Published in: Human vaccines & immunotherapeutics 2021-04, Vol.17 (4), p.955-964
• Main Authors: Hu, Shangying, Xu, Xiaoqian, Zhu, Fengcai, Hong, Ying, Hu, Yuemei, Zhang, Xun, Pan, Qinjing, Zhang, Wenhua, Zhang, Chengfu, Yang, Xiaoping, Yu, Jiaxi, Zhu, Jiahong, Zhu, Yejiang, Chen, Feng, Zhao, Shuang, Karkada, Naveen, Tang, Haiwen, Bi, Dan, Struyf, Frank, Zhao, Fanghui
• Format: Article
• Language: English
• Subjects: cervical cancer; China; clinical trial; efficacy; Human papillomavirus; infection; prevention; Research Paper; vaccines
• ISSN: 2164-5515; 2164-554X
• DOI: 10.1080/21645515.2020.1829411

Human papillomavirus (HPV) vaccines are efficacious against HPV infections and associated lesions in women HPV-naïve at vaccination. However, vaccine efficacy (VE) against oncogenic, high-risk HPV (HR-HPV) types in women infected with any other HR-HPV type at first vaccination (baseline) remains unclear. This post-hoc analysis of a phase II/III study (NCT00779766) evaluated AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) VE against HR-HPV type infection in 871 Chinese women aged 18-25 years over a 72-month follow-up period. Study participants were DNA-negative at baseline to HR-HPV type(s) considered for VE and DNA-positive to any other HR-HPV type. Initial serostatus was not considered. Baseline DNA prevalence was 14.6% for any HR-HPV type and 10.6% excluding HPV-16/18. In the total vaccinated cohort for efficacy, VE against 6-month and 12-month HPV-16/18 persistent infections (PIs) in women DNA-negative to HPV-16/18 but DNA-positive to any other HR-HPV type at baseline was 100.0% (95% Confidence Interval [CI]: 79.8-100.0) and 100.0% (95%CI: 47.2-100.0), respectively. VE against HPV-16/18 incident infections in women DNA-positive to one vaccine type but DNA-negative to the other one at baseline was 66.8% (95%CI: −18.9-92.5). VE against HPV-31/33/45 incident infections, in women DNA-positive to HPV-16/18 and DNA-negative to the considered HPV type at baseline was 71.0% (95%CI: 27.3-89.8). No HPV-16/18 PIs were observed in vaccinated women with non-vaccine HPV A7/A9 species cervical infection at baseline. These findings indicated that women with existing HR-HPV infection at vaccination might still benefit from the AS04-HPV-16/18 vaccine. However, this potential benefit needs further demonstration in the future. What is the context? Women who are human papillomavirus (HPV) naïve can be protected through HPV vaccines against infections and precancerous lesions caused by oncogenic HPV types. In China unvaccinated adult women may seed vaccination services on a user-pay basis. These women are more likely to be sexually active and may have ongoing HPV infection at vaccination. Public health agencies and healthcare professionals need more evidence on HPV vaccines benefit in the population already infected with oncogenic HPV type. What is new? We observed high vaccine efficacy of the AS04-HPV-16/18 vaccine against vaccine type HPV-16 and /or -18 infections in 18- to 25-year-old women infected with any other oncogenic HPV type at vaccination. Some cress-protection agains