58) in healthy Chinese women aged 20-45 years: a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial.

2025-11-14
Frontiers in immunology 16
- Mingwei Wei
- Hongyan Liu
- Hongyang Yu
- Hongxing Pan
- Hong Tao
- Jing Zhang
- Weiwei Han
- Dan Wu
- Wenjuan Wang
- Jingxin Li

PubMed: 41322412
DOI: 10.3389/fimmu.2025.1706662

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 780
Population: healthy women aged 20-45 years
Methods: single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial; participants randomly assigned (1:1:1) to receive 270 ug 9vHPV, 360 ug 9vHPV, or the control vaccine (Gardasil) with a 0-2-6-month schedule; serum samples collected at day 0 and month 7
Blinding: Single-blind
Duration: 0-2-6-month schedule

Large Human Trial

Background

Vaccination with prophylactic human papillomavirus (HPV) vaccines is one of the most effective measures to prevent cervical cancer and other related diseases. Here we aimed to evaluate the immunogenicity and safety of an Escherichia coli-produced 9-valent human papillomavirus (9vHPV) vaccine.

Method

We did a single-center, randomized, observer-blinded, positive controlled phase 2 clinical trial in healthy women aged 20-45 years. All eligible participants were randomly assigned (1:1:1) to receive 270 ug 9vHPV, 360 ug 9vHPV, or the control vaccine (Gardasil) with a 0-2-6-month schedule. Serum samples were collected at day 0 and month 7 to assess IgG and neutralizing antibodies (nAbs). For HPV 6/HPV 11/HPV 16/HPV 18, non-inferiority was identified for the lower limit of the 95% CI of the geometric mean titer (GMT) ratio at a margin of 0.5 and a seroconversion rate (SCR) difference at a margin of -5%. For HPV 31/HPV 33/HPV 45/HPV 52/HPV 58, superiority was demonstrated if the lower limit of the 95% CI for GMT ratio is greater than 1.

Results

A total of 780 participants aged 20-45 years were enrolled, among whom 770 completed the three-dose immunization schedule. The incidences of ARs within 7 days in the 270 μg, 360 μg, and positive control groups were 38.85%, 41.92%, and 22.69%, respectively (P < 0.001). The GMTs of nAbs and IgG antibodies for nine HPV types in both 270 ug and 360 ug groups showed an obvious rise at month 7. For HPV 31/HPV 33/HPV 45/HPV 52/HPV 58, the GMTs of nAbs in both 270 μg and 360 μg groups were higher than those in the positive control group, with the 95% CI lower bounds of GMT ratios all greater than 1. Compared to the positive control group, HPV 6 and HPV 18 achieved non-inferiority criteria for GMT in both dose groups. However, the GMT ratio of HPV 16 in the 270 μg group was 0.46 (0.38-0.55), and HPV 16 and HPV 11 in the 360 μg group were 0.48 (0.40-0.58) and 0.53 (0.46-0.60), respectively. The SCRs of nAbs for HPV 6/HPV 11/HPV 16/HPV 18 in the three groups were 100%, with the 95% CI lower bound for SCR differences ranging from -2.55% to -1.64%.

Conclusion

The candidate 9vHPV vaccine was well tolerated and immunogenic, supporting further evaluation for efficacy and safety in larger populations.

Clinical trial registration

https://clinicaltrials.gov, identifier NCT05694728.