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NCT Number: NCT07156084

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

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.

Recruiting

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Key information

Conditions

Age range

15 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre de recherche du CHU de Québec-Université Laval

Québec, Quebec, G1X4S9, Canada

Location status: Recruiting

Location contact

Chantal Sauvageau, MD

CONTACT

[email protected]

1+ 418 666-7000

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

HPV nonavalent vaccine (Gardasil-9)

Biological

One dose HPV nonavalent vaccine

Primary outcomes

  1. Detectable antibodies

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

    Proportion of participants with detectable antibodies

  2. Geometric mean concentrations

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

    Geometric mean concentrations of antibodies

Study contacts

Contact information is provided by the study sponsor or research team.

Chantal Sauvageau, MD

CONTACT

[email protected]

418650-5115 ext. 6368

Jo-Ann Costa

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Canadian Immunization Research Network

Network

Registry information

Acronym: CIRN-HPV-ONE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2025
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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