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

NCT05932576 | Unknown DMC

• 1 other identifier: HVAC2302
• Study Type: observational
• Target: 12,000
• Locations: 1 country
• Sites: 5

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 9 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women aged 9-45 years who received their last dose of HPV vaccine within 12 months

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (5)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Fujian Provincial Center for Disease Control and Prevention

Fuzhou, Fujian, China

RECRUITING

Maternal and Child Health Hospital of Shenzhen Province

Shenzhen, Guangdong, China

RECRUITING

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital, Central South University

Changsha, Hunan, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood sample

Study Officials

• Sun Pengming, PhD

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

  STUDY CHAIR

Central Study Contacts

Dong Binhua

CONTACT

13599071900; dbh18-jy@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Laboratory of Gynecologic Oncology

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 6, 2023
• Study Start: December 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

CN (5)