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Trial Title:
Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity
NCT ID:
NCT06137352
Condition:
HPV Infection
HPV Vaccine
Cervical Cancer Prevention
Conditions: Official terms:
Papillomavirus Infections
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Follow up
Description:
Each subject was recruited in 30-60 days after the last dose of domestic bivalent HPV
vaccine or imported HPV vaccine, and followed up at 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, with a total of two follow-up visits. At enrollment and
both follow-up visits, subjects were required to collect 2 tubes of peripheral venous
blood each.
Arm group label:
Adolescent females who received their first dose of HPV vaccine at 13-14 years
Summary:
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.
Detailed description:
The study aims to: 1) Evaluate the immunogenicity of two different domestically produced
bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus imported HPV vaccines in
adolescent females aged 13-14 years old; 2) Evaluate the immune persistence of two
different domestically produced bivalent HPV vaccines (Wozehui ® and Cecolin ®) versus
imported HPV vaccines in adolescent females aged 13-14 years old. This study is a
multi-center, open, prospective cohort study with a total of 3,000 subjects recruited.
According to the HPV vaccine that the participants received in the previous period, they
were divided into 1,000 people in the domestic bivalent HPV vaccine group (Wozehui),
1,000 people in the domestic bivalent HPV vaccine group (Cecolin), and 1,000 people in
the imported HPV vaccine group. Three immuneogenic blood was collected in all subjects
30-60 days, 12 months (window period ± 1 month) and 36 months (window period ± 1 month)
after the last dose of either the domestic bivalent HPV vaccine or the imported HPV
vaccine, which was used to perform HPV type 16 and 18 neutralizing antibody testing. The
aim of this study was to evaluate the immunogenicity difference between two different
domestically produced bivalent HPV vaccines and imported HPV vaccines in adolescent
females aged 13-14 years.
Criteria for eligibility:
Study pop:
Adolescent females between the ages of 13-14 years old at the time of the first dose of
HPV vaccination who have completed their last dose of domestic bivalent HPV vaccine or
imported HPV vaccine.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
13 Years
Maximum age:
14 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fujian Maternity and Child Health Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Start date:
December 15, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Fujian Maternity and Child Health Hospital
Agency class:
Other
Source:
Fujian Maternity and Child Health Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06137352
