Study on the Epidemiological Characteristics of Female HPV Vaccination in China

NCT05932563 | Unknown

• 1 other identifier: HVAC2301
• Study Type: observational
• Target: 1,700
• Locations: 1 country
• Sites: 6

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, studies have confirmed that carcinogenic HPV type continuous infection leads to higher incidence of condyloma acuminatum and cervical cancer, while increasing the risk of oropharyngeal cancer, vaginal cancer and other related cancers. Human papillomavirus vaccines have been widely used worldwide to prevent cancers of the lower reproductive tract, such as cervical, anal and vulvar cancers. According to the type, it is divided into domestic two-valent (Vantage), imported two-valent (GlaxoSmithKline), four-valent (Merck) and nine-valent (Merck)HPV vaccines. All four vaccines prevent high-risk HPV 16/18 infection, and there are differences between the quadrivalent and nine-valent HPV vaccine prevention genotypes. The protection rate, immunizing target and immunizing procedure of different valence number are slightly different. Studies have shown that after women receive HPV vaccine, the incidence of arm redness, swelling, fever, pain and other adverse reactions is high, often accompanied by menstrual disorders, sleep problems, emotional irritability, fever, dizziness, headache and other adverse reactions. However, the causal relationship between HPV vaccination and symptoms after vaccination at different prices is controversial, and there is little research in this area. Therefore, we intend to design a multicenter, bidirectional cohort study to investigate the relationship between HPV vaccination with different valence numbers and adverse reactions after vaccination in Chinese women, and to further explore the unknown potential factors affecting the protective effect of HPV vaccine.

Conditions

Human Papillomavirus Vaccines; Adverse Effect; Epidemiology; China; Woman

Outcome Measures

Primary Outcomes (6)

• Human Papillomavirus (HPV) genotyping tests

  All participants were tested for human oncovirus (HPV) genotyping prior to the first dose of HPV vaccination

  Baseline (Before the first dose of HPV vaccination)

• Human Papillomavirus (HPV) genotyping tests

  Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at one month after the third dose of HPV vaccination

  one month after the third dose of HPV vaccination

• Human Papillomavirus (HPV) genotyping tests

  Prospective cohort subjects underwent Human Papillomavirus (HPV) genotyping tests at 12-month after the third dose of HPV vaccination

  12-month after the third dose of HPV vaccination

• HPV vaccine neutralizing antibody detection

  Prospective cohort subjects were tested for neutralizing antibodies to the HPV vaccine at one month after the third dose of HPV vaccination

  one month after the third dose of HPV vaccination

• Human Papillomavirus (HPV) genotyping tests

  Participants in the retrospective cohort were tested for human oncovirus (HPV) genotyping 1-12 months after the third dose of HPV vaccination

  1 to 12 months after the third dose of HPV vaccination

• HPV vaccine neutralizing antibody detection

  Participants in the retrospective cohort were tested for HPV vaccine neutralizing antibodies 1-12 months after the third dose of HPV vaccine

  1 to 12 months after the third dose of HPV vaccination

Study Arms (2)

The HPV vaccine group

For retrospective cohort population: This study will be based on the database with HPV typing results before HPV vaccination, and the epidemiological characteristics such as adverse reaction symptoms after HPV vaccination in this population will be followed up by telephone or face-to-face, and 1 cervical exfoliated cell and 1 peripheral blood tube will be collected within 1-12 months after HPV vaccination. For the prospective cohort: All subjects will be enrolled at the time of the first dose of HPV vaccine, followed up 30-60 days after the last dose of HPV vaccine and 12 months after the last dose of HPV vaccine. One cervical exfoliated cell was collected at enrollment and two follow-up visits, and one peripheral blood tube was collected at 30-60 days follow-up after the last dose of HPV vaccine.

Unvaccinated HPV group

Exfoliated cervical cells were collected to test for HPV genotyping, or HPV genotyping results had been available for nearly 1 year prior to enrollment

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 9 to 45 years of age who have a sexual history and are about to receive their first dose of HPV vaccine, or have had HPV genotyping results for nearly 1 year before receiving HPV vaccine.

You may qualify if:

• The retrospective cohort must meet the following conditions:
• HPV typing results before HPV vaccination;
• 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:
• Female, 9-45 years old (sexual life history);
• 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;
• Will receive the first dose of HPV vaccine;
• There is no abnormal psychological or physical condition before HPV vaccination.

You may not qualify if:

• 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;
• Women who plan to become pregnant within the next two years;
• 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;
• Subjects with a history of epilepsy, psychosis, medically treatable major depression, convulsions or convulsions, or subjects with a family history of psychosis;
• Subjects with spleen insufficiency, functional spleen insufficiency, and any disease that results in spleen insufficiency or splenectomy;
• 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.
• Pregnant or lactating women;
• Asexual life history;
• The investigator believes that there are other factors that are not suitable for participants to participate in clinical trials.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (6)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, 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

Biospecimen

Retention: SAMPLES WITH DNA

DNA specimens of exfoliated cervix cells#Peripheral blood sample

Study Officials

• Pengming Sun, PhD

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

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

13599071900; dbh18-jy@126.com

Study Design

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

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 6, 2023
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 6, 2023

Record last verified: 2023-06

Locations

CN (6)