Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity

NCT06137352 | Not Yet Recruiting DMC

• 1 other identifier: HVAC2303
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV Infection; HPV Vaccine; Cervical Cancer Prevention

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Adolescent females who received their first dose of HPV vaccine at 13-14 years

Adolescent females who completed their last dose of domestic bivalent HPV vaccine or imported HPV vaccine and were between 13 and 14 years of age at the time of the first dose. Two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of vaccination.

Other: Follow up

Interventions

Follow up OTHER

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.

Adolescent females who received their first dose of HPV vaccine at 13-14 years

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Maternity and Child Health Hospital: lead

Study Sites (1)

Fujian Maternity and Child Health Hospital

Fuzhou, Fujian, 350001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Venous Blood Samples

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pengming Sun

  Fujian Maternal and Child Health Hospital

  STUDY CHAIR

Central Study Contacts

Binhua Dong

CONTACT

+86-591-87558732; dbh18-jy@126.com

Pengming Sun

CONTACT

+86-591-87558732; sunfemy@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: December 15, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

CN (1)