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

NCT06776055 | Active Not Recruiting

• 1 other identifier: 311-HPV-1003-EXTEND
• Study Type: observational
• Target: 5,372
• Locations: 1 country
• Sites: 9

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

Keywords

Bivalent HPV vaccine; Long-term protective efficacy

Outcome Measures

Primary Outcomes (1)

• Cumulative Protective Efficacy Against HPV-16 and/or HPV-18-Related Cervical Intraepithelial Neoplasia (CIN) Grade 2 or Higher (CIN2+), Adenocarcinoma In Situ (AIS), and Cervical Cancer

  Up to 96 months and 120 months after initial vaccination in base study.

Secondary Outcomes (3)

• Cumulative protective efficacy against cytological HPV-16 and/or HPV-18 infection

  Up to 96 months and 120 months after initial vaccination in base study.

• Cumulative protective efficacy against HPV-16 and/or HPV-18-related CIN1+

  Up to 96 months and 120 months after initial vaccination in base study.

• HPV 16/18 neutralizing antibody GMT and seropositivity rates

  At 96 months and 120 months after initial vaccination in base study.

Study Arms (2)

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 .

Biological: HPV-16/18 vaccine

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 .

Biological: Placebo

Interventions

HPV-16/18 vaccine BIOLOGICAL

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

HPV-2 vaccine group

Placebo BIOLOGICAL

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Participants in this long-term follow-up study were originally enrolled in the 311-HPV-1003 study and are drawn from multiple clinical sites across four provinces in China, including Guangxi, Hebei, Henan, and Shanxi. These participants represent a community-based sample of healthy women who received at least one dose of the Bivalent HPV vaccine or Placebo during the original study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zerun Biotechnology Co.,Ltd: lead
• Yuxi Zerun Biotechnology Co., Ltd.: collaborator

Study Sites (9)

Lingchuan Center for Disease Control and Prevention

Lingchuan, Guangxi, China

Location

Quanzhou Center for Disease Control and Prevention

Quanzhou, Guangxi, China

Location

Xing'an Center for Disease Control and Prevention

Xing’an, Guangxi, China

Location

Daming Center for Disease Control and Prevention

Daming, Hebei, China

Location

Dingxing Center for Disease Control and Prevention

Dingxing, Hebei, China

Location

Zhengding Center for Disease Control and Prevention

Zhengding, Hebei, China

Location

Puyang Center for Disease Control and Prevention

Puyang, Henan, China

Location

Wenxian Center for Disease Control and Prevention

Wenquan, Henan, China

Location

Xiangfen County People's Hospital

Xincheng, Shanxi, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

1. Cervical Samples: Cervical exfoliated cells collected at the 96-month and 120-month visits for ThinPrep Cytologic Testing (TCT) and HPV DNA typing. 2. Biopsy Samples: Tissue samples collected during colposcopy procedures, if biopsy is deemed necessary.

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Uterine Cervical Dysplasia; Papillomavirus Infections

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vulvar Diseases; Vaginal Diseases; Precancerous Conditions; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 15, 2025
• Study Start: March 27, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 15, 2025

Record last verified: 2024-12

Locations

CN (9)