The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age

Chao Zhao; Yun Zhao; Jingran Li; Mingzhu Li; Yanyan Su; Xin Mi; Su Yi La Tu; Danhua Shen; Lihua Ren; Yanyan Li; Linhong Wang; Lihui Wei

doi:10.1080/21645515.2022.2052700

The eight-year long-term follow-up on the effectiveness of the quadrivalent human papillomavirus vaccine in Chinese women 20-45 years of age

Hum Vaccin Immunother. 2022 Nov 30;18(5):2052700. doi: 10.1080/21645515.2022.2052700. Epub 2022 Mar 31.

Authors

Chao Zhao¹, Yun Zhao¹, Jingran Li¹, Mingzhu Li¹, Yanyan Su², Xin Mi², Su Yi La Tu³, Danhua Shen¹, Lihua Ren¹, Yanyan Li¹, Linhong Wang⁴, Lihui Wei¹

Affiliations

¹ Department of Obstetrics and Gynecology, Peking University People's Hospital, Beijing, China.
² Department of Obstetrics and Gynecology, Shunyi Maternity and Child Health Hospital, Beijing, China.
³ Department of Obstetrics and Gynecology, Xilinguolemeng Xianghuangqi Maternity and Child Health Hospital, Inner Mongolia Autonomous Region, China.
⁴ National Center for Women and Children's Health, Chinese Center for Disease Control and Prevention, Beijing, China.

Abstract

The quadrivalent human papillomavirus (4vHPV) vaccine has shown confirmative effectiveness in preventing HPV-related diseases among women and men around the globe. The phase III, randomized, double-blind efficacy study (Base study, NCT00834106) conducted in China showed 100% efficacy against HPV 16/18-related cervical intraepithelial neoplasia and efficacy against HPV persistent infection for 78 months. Participants aged 20-45 years who received three doses of 4vHPV vaccine or placebo during the base study were selected and invited for this long-term follow-up (LTFU) study to assess the long-term effectiveness of the 4vHPV vaccine in preventing HPV-related diseases. A total of 368 participants were included in this LTFU study with a median follow-up of 94 months. Among 27 participants (Vaccine vs. Placebo: 8 vs. 19) who underwent colposcopy and biopsy due to cervical cytological abnormalities or HPV infection, no HPV-16/18-related cases of cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), or vaginal intraepithelial neoplasia (VaIN) was observed in the vaccine group while two HPV-16-related cases (CIN1/VaIN) were observed in the placebo group. There were another two HPV-related cases (non-vaccine HPV types) found in the placebo group. Consistent with the findings from global studies that suggested long-term efficacy of 4vHPV vaccine, our study showed continued protective effect of 4vHPV vaccine against HPV-related precancerous diseases through a median follow-up time of 94 months with the longest follow-up time of 125 months after completing three doses of vaccination among Chinese women 20-45 years of age.

Keywords: Human papillomavirus vaccine; effectiveness; long-term follow-up.

Publication types

Clinical Trial, Phase III
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
China
Double-Blind Method
Female
Follow-Up Studies
Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18* / administration & dosage
Human papillomavirus 16
Human papillomavirus 18
Humans
Immunization Schedule
Middle Aged
Papillomaviridae
Papillomavirus Infections* / prevention & control
Uterine Cervical Dysplasia* / prevention & control
Uterine Cervical Dysplasia* / virology
Vaccine Efficacy
Young Adult

Substances

Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18

Grants and funding

We thank the funding from Association for Maternal and Child Health Studies [2018AMCHS008, 2018AMCHS00803] and Project of Development center for medical science & technology, NHC.