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Clinical Trials/NCT05932576
NCT05932576
Recruiting
Not Applicable

A Multicenter Cohort Study Assessing the Efficacy and Adverse Effects of Different HPV Vaccination in Chinese Women

Fujian Maternity and Child Health Hospital5 sites in 1 country12,000 target enrollmentDecember 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Human Papillomavirus Vaccines
Sponsor
Fujian Maternity and Child Health Hospital
Enrollment
12000
Locations
5
Primary Endpoint
HPV vaccine neutralizing antibody detection
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

Human papillomavirus (HPV) is currently one of the most common sexually transmitted infections, according to its carcinogenicity is divided into high-risk genotypes and low-risk genotypes, research has confirmed that carcinogenic HPV type continuous infection leads to a higher incidence of condyloma acuminatum and cervical cancer, while increasing the oropharyngeal cancer, vaginal cancer and other related cancer risk. HPV vaccines have been widely introduced worldwide to prevent cancers of the lower genital tract such as cervical, anal and vulvar cancers. For different types of HPV vaccine, divided into domestic bivalent, imported bivalent (GlaxoSmithKline), quadrivalent (Merck) and nine-valent (Merck) HPV vaccine, four vaccines all prevent HPV 16/18 high-risk type infection disease, and the four and nine-valent HPV vaccine prevention genotypes are different, and different price number of protection rates, vaccination objects and immunization procedures are slightly different. At the same time, studies have shown that women after HPV vaccine, arm redness, swelling, heat and pain have a high incidence of adverse reactions, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions risk, so we plan to design a multicenter cohort study to evaluate the effectiveness of HPV vaccine with different prices. At the same time, the adverse reaction symptoms of HPV vaccine in the female population of appropriate age were monitored.

Detailed Description

This study was led by the Fujian Provincial Maternal and Child Health Hospital, with the following research centers: Xiangya Hospital of Central South University, Fujian Provincial Center for Disease Control and Prevention, Shenzhen Maternal and Child Health Hospital, Hubei Provincial Maternal and Child Health Hospital, Shandong Province and Shaanxi Province. Recruitment was conducted in 6 provinces in different regions of China, and 2000 subjects were recruited in each province. A total of 12,000 subjects were recruited. Each subject was evaluated within 3 to 12 months after the last dose of HPV vaccine, and adverse reaction symptoms were queried by telephone follow-up and face-to-face. Peripheral blood 1 tube (3ml) was collected to detect the concentration of comprehensive antibodies to HPV vaccine. A multicenter cohort study was conducted to evaluate the effectiveness of HPV vaccine and to monitor the symptoms of adverse reactions to HPV vaccine in the female population of appropriate age.

Registry
clinicaltrials.gov
Start Date
December 1, 2022
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Fujian Maternity and Child Health Hospital
Responsible Party
Principal Investigator
Principal Investigator

Binhua Dong

Laboratory of Gynecologic Oncology

Fujian Maternity and Child Health Hospital

Eligibility Criteria

Inclusion Criteria

  • Female, aged 9-45; Get the last dose of HPV vaccine within 12 months.

Exclusion Criteria

  • Pregnancy or lactation during HPV vaccination; Those who refuse follow-up and informed consent.

Outcomes

Primary Outcomes

HPV vaccine neutralizing antibody detection

Time Frame: Within 3 to 12 months of each subject's last dose of HPV vaccine

All participants were tested for neutralizing antibodies to the HPV vaccine

Study Sites (5)

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