Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students

NCT07156084 | Recruiting Phase 4

• 1 other identifier: CT-26 CIRN HPV 1 dose
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV Vaccine

Keywords

HPV; Vaccination; Schedule

Outcome Measures

Primary Outcomes (2)

• Detectable antibodies

  Proportion of participants with detectable antibodies

  At recruitment (6 years post-one HPV vaccine dose)

• Geometric mean concentrations

  Geometric mean concentrations of antibodies

  At recruitment (6 years post-one HPV vaccine dose)

Study Arms (1)

One HPV vaccine dose received 6 years before recruitment

EXPERIMENTAL

Biological: HPV nonavalent vaccine (Gardasil-9)

Interventions

HPV nonavalent vaccine (Gardasil-9) BIOLOGICAL

One dose HPV nonavalent vaccine

One HPV vaccine dose received 6 years before recruitment

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Immunosuppressed (at recruitment or when immunized).

Sponsors & Collaborators

• Canadian Immunization Research Network: lead

Study Sites (1)

Centre de recherche du CHU de Québec-Université Laval

Québec, Quebec, G1X4S9, Canada

RECRUITING

Study Officials

• Chantal Sauvageau, MD

  INSPQ and Laval University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chantal Sauvageau, MD

CONTACT

418650-5115; chantal.sauvageau@inspq.qc.ca

Jo-Ann Costa

CONTACT

jo-anne.costa.ciussscn@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2025
• First Posted: September 4, 2025
• Study Start: September 23, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 29, 2025

Record last verified: 2025-09

Locations

CA (1)