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

NCT ID: NCT07156084

Last Updated: 2025-09-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-23
• Study Completion Date: 2026-02-28

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.

Detailed Description

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. The second dose, which was to be administered five years after the first, was never administered following a recommendation from the Quebec Committee (of Experts) on Immunization (CIQ) in 2024. The current recommendation is to administer a single dose of 9vHPV vaccine to all immunocompetent individuals aged 9 to 20 years. The Canadian expert committee (National Advisory Committee on Immunization) and the World Health Organization (WHO) expert committee have made the same recommendation.

Little data on the immunogenicity (antibody production) and long-term efficacy of a single dose of the vaccine are available, particularly in boys.

The results of this study will allow for a better assessment of the immunity provided by a single dose of the HPV vaccine at the time when young people begin their sexual life and are exposed to HPV.

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, in the Vaccination Research Team clinic located in Quebec City.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

One HPV vaccine dose received 6 years before recruitment

Group Type: EXPERIMENTAL

HPV nonavalent vaccine (Gardasil-9)

Intervention Type: BIOLOGICAL

One dose HPV nonavalent vaccine

Interventions

HPV nonavalent vaccine (Gardasil-9)

One dose HPV nonavalent vaccine

Intervention Type: BIOLOGICAL

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Canadian Immunization Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chantal Sauvageau, MD

Role: PRINCIPAL_INVESTIGATOR

INSPQ and Laval University

Locations

Centre de recherche du CHU de Québec-Université Laval

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Chantal Sauvageau, MD

Role: CONTACT

chantal.sauvageau@inspq.qc.ca

418650-5115 ext. 6368

Jo-Ann Costa

Role: CONTACT

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

Facility Contacts

Chantal Sauvageau, MD

Role: primary

chantal.sauvageau@inspq.qc.ca

1+ 418 666-7000

Other Identifiers

CT-26 CIRN HPV 1 dose

Identifier Type: -

Identifier Source: org_study_id