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.
Based on the database with HPV typing results before HPV vaccination, this study will follow up the population's epidemiological characteristics such as adverse reaction symptoms after HPV vaccination through telephone or face to face, and collect 1 cervical exfoliated cell and 1 peripheral blood tube (5ml) for HPV genotyping detection and HPV neutralizing antibody detection. Meanwhile, participants were recruited in different regions of China for a period of three months. Follow-up was performed at the time of the first dose of HPV vaccine, 1 month after the third dose, and 12 months after the third dose. The corresponding questionnaire was filled in during enrollment and follow-up, and one cervical exfoliated cell was collected at each of the three follow-up visits for HPV genotyping. At the same time, the peripheral blood tubes were collected one month after the third injection to evaluate the effect of HPV vaccine neutralizing antibodies. The multi-center cohort study was conducted to explore the unknown potential factors affecting the protective effect of HPV vaccine, and the relationship between HPV vaccine with different price and adverse reactions after vaccination in Chinese women.
Study Type
OBSERVATIONAL
Enrollment
1,700
Fujian Maternity and Child Health Hospital
Fuzhou, Fujian, China
RECRUITINGFujian Provincial Center for Disease Control and Prevention
Fuzhou, Fujian, China
RECRUITINGFuzhou Shanghai street community health Service center
Fuzhou, Fujian, China
RECRUITINGShenzhen Maternal and Child Health Hospital
Shenzhen, Guangdong, China
RECRUITINGHubei Maternal and Child HealthCare Hospital
Wuhan, Hubei, China
RECRUITINGXiangya Hospital, Central South University
Changsha, Hunan, China
RECRUITINGHuman Papillomavirus (HPV) genotyping tests
All participants were tested for human oncovirus (HPV) genotyping prior to the first dose of HPV vaccination
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 to 12 months after the third dose of HPV vaccination
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