Epidemiological characteristics of female HPV vaccination in China

Study on the Epidemiological Characteristics of Female Different HPV Vaccination in China

This study looks at how the HPV vaccine affects women in China, including any side effects and how well it works, by following a group of females aged 9 to 45 who are getting vaccinated.

Quick facts

• Study type: Observational
• Enrollment: 1700 (estimated)
• Ages: 9 Years to 45 Years
• Sex: Female
• Sponsor: Fujian Maternity and Child Health Hospital (other)
• Locations: 6 sites (Fuzhou, Fujian and 5 other locations)
• Trial ID: NCT05932563 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the epidemiological characteristics and adverse reactions associated with HPV vaccination among women in China. It will follow a cohort of females aged 9-45 years who are receiving the HPV vaccine, collecting data through questionnaires and biological samples at multiple follow-up points. The study will analyze HPV typing results before vaccination and assess the presence of neutralizing antibodies after vaccination. The goal is to explore factors influencing the vaccine's protective effects and the relationship between vaccine type and adverse reactions.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 9-45 years who are willing to receive the HPV vaccine and participate in follow-up assessments.

Not a fit: Patients who have previously received another HPV vaccine or are planning to become pregnant within the next two years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of HPV vaccine efficacy and safety, leading to improved vaccination strategies for women.

How similar studies have performed: While there have been studies on HPV vaccination, this specific observational approach focusing on epidemiological characteristics and adverse reactions in a Chinese population is relatively novel.

Eligibility criteria

Inclusion Criteria:

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The retrospective cohort must meet the following conditions:

1. HPV typing results before HPV vaccination;
2. Willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or branch center for free examination.

Prospective cohort population must meet the following conditions:

1. Female, 9-45 years old (sexual life history);
2. In the next two years, I am willing to go to the main center of Fujian Provincial Maternal and Child Health Hospital or sub-centers for free check-ups;
3. Will receive the first dose of HPV vaccine;
4. There is no abnormal psychological or physical condition before HPV vaccination.

Exclusion Criteria:

1. Subjects who have previously received another commercially available HPV vaccine, or participated in a clinical study of HPV vaccine, or participated in a clinical study of another vaccine within the past 6 months;
2. Women who plan to become pregnant within the next two years;
3. Are immune deficient or have been diagnosed with congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, SLE, rheumatoid arthritis, juvenile rheumatoid arthritis (JRA), inflammatory bowel disease, or other autoimmune disease, and have received immunosuppressive therapy within the past 6 months;
4. Subjects with a history of epilepsy, psychosis, medically treatable major depression, convulsions or convulsions, or subjects with a family history of psychosis;
5. Subjects with spleen insufficiency, functional spleen insufficiency, and any disease that results in spleen insufficiency or splenectomy;
6. During the follow-up period, they were not willing to return to the main center or sub-center of the Fujian Maternal and Child Health Hospital to collect cervical exuded cells and/or peripheral blood samples, such as 30-60 days or 12 months after the last HPV vaccination.
7. Pregnant or lactating women;
8. Asexual life history;
9. The investigator believes that there are other factors that are not suitable for participants to participate in clinical trials.

Where this trial is running

Fuzhou, Fujian and 5 other locations

• Fujian Maternity and Child Health Hospital — Fuzhou, Fujian, China (RECRUITING)
• Fujian Provincial Center for Disease Control and Prevention — Fuzhou, Fujian, China (RECRUITING)
• Fuzhou Shanghai street community health Service center — Fuzhou, Fujian, China (RECRUITING)
• Shenzhen Maternal and Child Health Hospital — Shenzhen, Guangdong, China (RECRUITING)
• Hubei Maternal and Child HealthCare Hospital — Wuhan, Hubei, China (RECRUITING)
• Xiangya Hospital, Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Study coordinator: Binhua Dong

Conditions: Human Papillomavirus Vaccines, Adverse Effect, Epidemiology, China, Woman