Adverse Effect Clinical Trial
Official title:
Study on the Epidemiological Characteristics of Female Different HPV Vaccination in China
NCT number | NCT05932563 |
Other study ID # | HVAC2301 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | December 31, 2024 |
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.
Status | Recruiting |
Enrollment | 1700 |
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: - The retrospective cohort must meet the following conditions: 1. HPV typing results before HPV vaccination; 2. 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: 1. Female, 9-45 years old (sexual life history); 2. 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; 3. Will receive the first dose of HPV vaccine; 4. There is no abnormal psychological or physical condition before HPV vaccination. Exclusion Criteria: 1. 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; 2. Women who plan to become pregnant within the next two years; 3. 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; 4. Subjects with a history of epilepsy, psychosis, medically treatable major depression, convulsions or convulsions, or subjects with a family history of psychosis; 5. Subjects with spleen insufficiency, functional spleen insufficiency, and any disease that results in spleen insufficiency or splenectomy; 6. 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. 7. Pregnant or lactating women; 8. Asexual life history; 9. The investigator believes that there are other factors that are not suitable for participants to participate in clinical trials. |
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 | Fuzhou Shanghai street community health Service center | Fuzhou | Fujian |
China | Shenzhen Maternal and Child Health Hospital | Shenzhen | Guangdong |
China | Hubei Maternal and Child HealthCare Hospital | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Fujian Maternity and Child Health Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
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