Trials / Active Not Recruiting
Active Not RecruitingNCT06776055
Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women
A Multicenter, Open-label, Long-term Extension Study to Evaluate the Long-term Protective Efficacy and Immunogenic Persistence of the Bivalent Human Papillomavirus Vaccine (Pichia Pastoris) Administered to Healthy Females Aged 18-30 During the 311-HPV-1003 Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,372 (actual)
- Sponsor
- Shanghai Zerun Biotechnology Co.,Ltd · Industry
- Sex
- Female
- Age
- 18 Years – 30 Years
- Healthy volunteers
- Accepted
Summary
This extension study aims to evaluate the long-term protection and immune response of the bivalent HPV vaccine in women aged 18-30 who participated in a previous efficacy study (311-HPV-1003). Participants will be monitored over two years, with two visits at 96 and 120 months after their initial vaccination. No additional vaccine doses will be given. Cervical samples will be obtained for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. If applicable, participants meeting referral criteria for colposcopy will undergo the procedure during these visits, and tissue samples will be collected from those requiring a biopsy. Blood samples will be drawn from an immunology subset for antibody testing.The study includes data collection from multiple sites across China to assess the vaccine's long-term efficacy in preventing HPV-related cervical diseases and its durability over time.
Conditions
- Cervical Cancer
- Vulvar Cancer
- Vaginal Cancer
- CIN - Cervical Intraepithelial Neoplasia
- Human Papillomavirus Infection
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HPV-16/18 vaccine | Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) |
| BIOLOGICAL | Placebo | Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance. |
Timeline
- Start date
- 2023-03-27
- Primary completion
- 2025-06-01
- Completion
- 2026-06-01
- First posted
- 2025-01-15
- Last updated
- 2025-01-15
Locations
9 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06776055. Inclusion in this directory is not an endorsement.