HPV Infection Clinical Trial
Official title:
Two Domestic HPV Vaccines (Wozehui ® and Cecolin ®) and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity:A Multi-center Cohort Study in China
This is a multi-center, open, prospective cohort study that aims to investigate the immunogenicity and immune persistence of two different domestically produced bivalent HPV vaccines compared with an imported HPV vaccine in women aged 13-14 years. A total of 3,000 subjects who have completed 2 doses of the domestic bivalent HPV vaccine and 3 doses of the imported HPV vaccine will be recruited from Fujian Maternal and Child Health Hospital as the initiator of the study, and will be recruited from a number of healthcare institutions nationwide. Of these, 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Wozehui), 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Cecolin), and 1,000 subjects were vaccinated with the imported HPV vaccine. Each subject was enrolled within 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and a total of two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. In response to the WHO Cervical Cancer Elimination Strategy, domestic bivalent HPV vaccine has been offered free of charge to adolescent females aged 13-14 years, but there is still a lack of evidence comparing the antibody titer levels of domestic HPV vaccine and imported HPV vaccine in younger females. Therefore, we conducted the present immunogenicity study to explore the immunogenicity and immune persistence after vaccination with domestic bivalent HPV vaccine versus imported HPV vaccine in this age group of females.
Status | Not yet recruiting |
Enrollment | 3000 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 13 Years to 14 Years |
Eligibility | Inclusion Criteria: - Participants who have completed all procedures of domestic bivalent HPV vaccine or imported HPV vaccine and are 30-60 days from the last dose of vaccination at the time of enrollment; - The participants are between 13-14 years old at the time of the first dose of domestic or imported HPV vaccination; - The participant himself/herself and his/her guardian are able to provide proof of legal identity; - The participant and his/her guardian are capable of understanding and signing the informed consent form; - Participants are willing to complete study-related follow-up visits and blood collection as required by the protocol. Exclusion Criteria: - Participants who have received other marketed HPV vaccines, or who have participated in clinical studies of HPV vaccines, or who have participated in clinical studies of other vaccines within the last 6 months; - Participants with congenital malformations, developmental disorders, genetic defects, and severe malnutrition that are severe or cause damage to vital organs; - Participants with a history of epilepsy, psychosis, and major depression requiring medication, convulsions or seizures or a family history of psychosis; - Participants who are immune compromised 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 (IBD), or other autoimmune disease, subjects who have received immunosuppressive therapy within the past 6 months; - Absence of spleen, functional absence of spleen, and subjects with any condition resulting in absence of spleen or splenectomy; - Subjects with physician-diagnosed coagulation abnormalities (e.g., coagulation factor deficiencies, coagulopathies, platelet abnormalities) or significant bruising or coagulation disorders; - Participants who, in the judgment of the investigator, have any other factors that make them unsuitable for participation in a clinical trials. |
Country | Name | City | State |
---|---|---|---|
China | Fujian Maternity and Child Health Hospital | Fuzhou | Fujian |
Lead Sponsor | Collaborator |
---|---|
Fujian Maternity and Child Health Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The neutralization antibody GMT and antibody positivity testing at baseline | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested | Baseline | |
Primary | The neutralization antibody GMT and antibody positivity testing at 12-mouth follow-up | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 12 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. | 12-month follow-up | |
Primary | The neutralization antibody GMT and antibody positivity testing at baseline 36-mouth follow-up | The neutralization antibody GMT and antibody positivity for HPV types 16 and 18 were tested 36 mouths after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. | 36-month follow-up |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04098744 -
Artesunate Vaginal Inserts for the Treatment of Cervical Intraepithelial Neoplasia (CIN2/3)
|
Phase 2 | |
Completed |
NCT04083196 -
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
|
Phase 1 | |
Completed |
NCT04191967 -
Thermocoagulation for Treatment of Precancerous Cervical Lesions
|
N/A | |
Withdrawn |
NCT04430907 -
HPV Vaccine in Postpartum Women
|
||
Recruiting |
NCT02593968 -
Yallaferon in Chinese Population
|
Phase 2 | |
Completed |
NCT04711265 -
Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
|
||
Completed |
NCT02263378 -
A New Supplement for the Immune Response to HPV Infection
|
N/A | |
Completed |
NCT05234112 -
Prevention and Screening Towards Elimination of Cervical Cancer
|
N/A | |
Completed |
NCT04590521 -
HPV Vaccine Immunity in High-risk Women
|
Phase 4 | |
Recruiting |
NCT05829629 -
Phase 1 Dose-escalation Study of FluBHPVE6E7 in HPV16-infected Women
|
Phase 1 | |
Recruiting |
NCT06052033 -
Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection
|
N/A | |
Recruiting |
NCT05051852 -
HPV Viral Load in Predicting the Prognosis of LSIL
|
||
Completed |
NCT04155294 -
Re-Evaluation of Annual Cytology Using HPV Testing to Upgrade Prevention in Women Living With HIV
|
||
Active, not recruiting |
NCT06452004 -
Validation of Artificial Intelligence as Decision Support System in VIA (PRESCRIP-TEC)
|
N/A | |
Completed |
NCT06177236 -
Clinic or Self-Sampling for Cervical Cancer Screening
|
N/A | |
Active, not recruiting |
NCT04794660 -
The Study for the "Cervical Cancer Screening and Treatment Algorithms Study Using HPV Testing in Africa"
|
Phase 3 | |
Recruiting |
NCT05509413 -
DEFLAGYN® Vaginal Gel and Spontaneous Remission and Regression of Unclear Cervical Smears and HPV High-risk Infections
|
N/A | |
Recruiting |
NCT06137950 -
Interferon Alpha Therapy for Cervical CINI and HPV Infection
|
Phase 1 | |
Recruiting |
NCT04171505 -
Retrospective Cohort Study of the Effectiveness of the Prophylactic Vaccine Against the Human Papilloma Virus in the Prevention of Recurrence in Women Who Have Received an Excisional Therapy by HSIL / CIN.
|
||
Active, not recruiting |
NCT05524025 -
The SPOT-HPV Study
|