Long-term Follow-up of Bivalent Human Papillomavirus (HPV) Vaccine Study in Women

NCT ID: NCT06776055

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 5372 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2026-06-30

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

HPV-2 vaccine group

Participants received the bivalent HPV vaccine (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study .

HPV-16/18 vaccine

Intervention Type: BIOLOGICAL

Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)

Placebo group

Participants received the placebo (0.5 mL in a 3-dose regimen) in the base study (NCT02733068). No study vaccination will be administered in long-term follow-up study .

Placebo

Intervention Type: BIOLOGICAL

Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.

Interventions

HPV-16/18 vaccine

Recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast)

Intervention Type: BIOLOGICAL

Placebo

Placebo containing the same formulation as the active vaccine (Type 16 and 18 L1 proteins, Yeast) but without the active substance.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Have the ability to understand and provide informed consent by signing the informed consent form (non-illiterate).
• Have the ability to comply with protocol requirements, such as attending scheduled visits and responding to follow-up phone calls.
• Prior enrollment in the 311-HPV-1003 study, with at least one dose of the study vaccine administered.
• At least one documented gynecological visit between 6 and 48 months during the previous 311-HPV-1003 study.
• Refrain from vaginal intercourse for 48 hours and avoid behaviors such as vaginal douching or using vaginal medications that could interfere with gynecological examinations or sample collection for 72 hours prior to each gynecological visit.

Exclusion Criteria

• Participants who received another HPV vaccine during the prior 311-HPV-1003 study or between the end of that study and enrollment in this extension study.
• Participants diagnosed with HPV 16- or 18-related CIN2+ by an independent pathology expert panel during the prior 311-HPV-1003 study, or who were definitively diagnosed with HPV 16- or 18-related CIN2+ through external testing after the prior study ended.
• Participants who, at baseline in the 311-HPV-1003 study, tested positive for both HPV 16 and 18 antibodies, or were positive for both HPV 16 and 18 (by Cobas 4800), or whose cytology was not normal or of low-grade changes.
• Participants who are pregnant at the time of gynecological visits or within three months prior to the visit.
• Participants with any other factors deemed unsuitable for participation in the clinical trial, as determined by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Yuxi Zerun Biotechnology Co., Ltd.

UNKNOWN

Sponsor Role: collaborator

Shanghai Zerun Biotechnology Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Lingchuan Center for Disease Control and Prevention

Lingchuan, Guangxi, China

Quanzhou Center for Disease Control and Prevention

Quanzhou, Guangxi, China

Xing'an Center for Disease Control and Prevention

Xing’an, Guangxi, China

Daming Center for Disease Control and Prevention

Daming, Hebei, China

Dingxing Center for Disease Control and Prevention

Dingxing, Hebei, China

Zhengding Center for Disease Control and Prevention

Zhengding, Hebei, China

Puyang Center for Disease Control and Prevention

Puyang, Henan, China

Wenxian Center for Disease Control and Prevention

Wenquan, Henan, China

Xiangfen County People's Hospital

Xincheng, Shanxi, China

Countries

China

Other Identifiers

311-HPV-1003-EXTEND

Identifier Type: OTHER

Identifier Source: secondary_id

311-HPV-1003-EXTEND

Identifier Type: -

Identifier Source: org_study_id