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

Adverse Effect Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05932576
• Other study ID #: HVAC2302
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: June 2023
• Source: Fujian Maternity and Child Health Hospital
• Contact: Dong Binhua
• Phone: 13599071900
• Email: dbh18-jy[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 9 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Xiangya Hospital, Central South University	Changsha	Hunan
China	Fujian Maternity and Child Health Hospital	Fuzhou	Fujian
China	Fujian Provincial Center for Disease Control and Prevention	Fuzhou	Fujian
China	Maternal and Child Health Hospital of Shenzhen Province	Shenzhen	Guangdong
China	Maternal and Child Health Hospital of Hubei Province	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HPV vaccine neutralizing antibody detection	All participants were tested for neutralizing antibodies to the HPV vaccine	Within 3 to 12 months of each subject's last dose of HPV vaccine