Assessing immune response after HPV vaccination in women

Evaluating the Immune Persistence of Recombination Quadrivalent HPV Vaccine (Type 6, 11, 16, 18) in Healthy Chinese Female Subjects Aged 9 to 45 Years: A Phase 3, Open-label, Non-randomized Clinical Trial

This study is testing how long the immune protection lasts in Chinese women aged 9-45 after they complete the full HPV vaccination schedule.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 9 Years to 45 Years
• Sex: Female
• Sponsor: Shanghai Bovax Biotechnology Co., Ltd. (industry)
• Locations: 2 sites (Yangchun, Guangdong and 1 other locations)
• Trial ID: NCT05371353 on ClinicalTrials.gov

What this trial studies

This observational study evaluates the immune persistence in Chinese women aged 9-45 years who have completed the full vaccination schedule of the quadrivalent HPV vaccine. Participants will have received their vaccinations at 0, 2, and 6 months, and will provide blood samples to assess their immune response at the 7-month mark. The study aims to gather data on how long the immune protection lasts following vaccination against HPV-related conditions such as cervical cancer and genital warts.

Who should consider this trial

Good fit: Ideal candidates for this study are Chinese women aged 9-45 who have completed the quadrivalent HPV vaccination schedule and provided blood samples as required.

Not a fit: Patients who have not received the quadrivalent HPV vaccine or those outside the specified age range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness of the HPV vaccine, potentially leading to improved vaccination strategies.

How similar studies have performed: While similar studies on HPV vaccine efficacy exist, this specific assessment of immune persistence is relatively novel.

Eligibility criteria

Inclusion Criteria:

* Subjects who participated in the phase III clinical trial of non inferior efficacy of HPV tetravalent vaccine of Yangchun Center for Disease Control and Prevention (protocol No.: 4-HPV-3001), completed three doses of HPV quadrivalent vaccine and provided blood sample at months 7; Or subjects who have participated in the bridging study of HPV quadrivalent vaccine of Mianyang Center for Disease Control and Prevention (scheme No.: 4-HPV-3002), completed the whole vaccine schedule at month 0，2，6, and provided blood sample at months 7;
* The subjects aged 9 to 17 years old at Mianyang site and their legal guardian should provide legal indentification; the subjects aged over 18 years old should provide legal indentification;
* The subject voluntarily agrees to enroll in this study. If the subject is a minor, both the subject and subject's legal guardian should voluntarily agree to enroll in this study and sign an informed consent form;
* Be able to understand the study procedures and promise to participate in regular follow-ups under the requirements.

Exclusion Criteria:

* Enrolling or plan to enroll in other clinical trials (drugs or vaccines) (except that the observational clinical study and the subjects at Mianyang site are still in the post exemption safety follow-up stage of the 4-HPV-3002 trial);
* Suffering from thrombocytopenia or any coagulation dysfunction that can be a contraindication to blood collection (such as coagulation factor deficiency, coagulation diseases, platelet abnormalities, etc.);
* According to the investigator's judgment, the subject has any condition may interfere with process of evaluation of immune persistence.

Where this trial is running

Yangchun, Guangdong and 1 other locations

• Yangchun Center For Disease Prevention And Control — Yangchun, Guangdong, China (RECRUITING)
• Center for Disease Control and Prevention — Mianyang, Sichuan, China (RECRUITING)

Study contacts

• Study coordinator: Jikai Zhang

Conditions: HPV Infections, Cervical Cancer Stage IIa, Vaginal Cancer, Genital Wart, CIN1, CIN2, CIN3, Human papillomavirus