NCT07156084 Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students
| NCT ID | NCT07156084 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Canadian Immunization Research Network |
| Condition | HPV Vaccine |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-09-23 |
| Primary Completion | 2026-02 |
Trial Parameters
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Brief Summary
Since the 2019-2020 school year, the province of Quebec (Canada) has been administering one dose of nonavalent (9vHPV) vaccine to students of all genders in Grade 4 of elementary school through the school-based program. Little data on the immunogenicity (antibody production) and long-term efficacy of a single dose of the vaccine are available, particularly in boys. The primary objective of this study is to assess the persistence of HPV antibodies six years after the administration of a single dose of the 9vHPV vaccine to students aged 9 to 11 years in Grade 4 in 2019-2020. The study will be conducted at the CHU de Québec-Université Laval research center. Recruitment is conducted through school service centers in the Quebec City region. Youth who received only a single dose of the 9vHPV vaccine at the ages of 9-11 in 2019-2020 will be eligible to participate. Approximately 300 youth will take part in this study: 150 girls and 150 boys. Participants will have to answer few questions about their health to ensure their eligibility for the study. For eligible participants consenting to participate a 10 ml (\<1 tablespoon) blood sample will be taken.
Eligibility Criteria
Inclusion Criteria: * Have received a single dose of 9vHPV vaccine at ages 9-11 during the school year 2019-2020; * Not have received any other HPV vaccine doses; * Be able to consent to the study. Exclusion Criteria: * Immunosuppressed (at recruitment or when immunized).