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

NCT ID: NCT05932576

Last Updated: 2023-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2024-12-31

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.

Conditions

Human Papillomavirus Vaccines; Efficacy, Self; Adverse Effect; China; Woman

Study Design

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

Study Groups

The HPV vaccine group

Women aged 9-45 years who received the last dose of HPV vaccine within the past 12 months were included, and each subject was evaluated within 3-12 months after the last dose of HPV vaccine. Adverse reaction symptoms were queried by telephone follow-up and face-to-face, and peripheral blood tube (3ml) was collected to detect the concentration of comprehensive antibody to HPV vaccine.

No interventions assigned to this group

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.

• Minimum Eligible Age: 9 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Fujian Maternity and Child Health Hospital

OTHER

Sponsor Role: lead

Responsible Party

Binhua Dong

Laboratory of Gynecologic Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sun Pengming, PhD

Role: STUDY_CHAIR

Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University

Locations

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Fujian Provincial Center for Disease Control and Prevention

Fuzhou, Fujian, China

Site Status: RECRUITING

Maternal and Child Health Hospital of Shenzhen Province

Shenzhen, Guangdong, China

Site Status: RECRUITING

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

Site Status: RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dong Binhua

Role: CONTACT

dbh18-jy@126.com

13599071900

Facility Contacts

Binhua Dong

Role: primary

dbh18-jy@126.com

+8613599071900

Weiyi Pan

Role: primary

13685031683 ext. 086

Zheng Zheng, M.D

Role: primary

+8613500056539

Hongning Cai, M.D

Role: primary

catherine-527@163.com

+8615926224867

Yu Zhang

Role: primary

cszhangyu@126.com

0731-88877216

Other Identifiers

HVAC2302

Identifier Type: -

Identifier Source: org_study_id