HPV VaccinePhase 4CIRN-HPV-ONENCT07156084
Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students
A Phase 4 study testing HPV nonavalent vaccine (Gardasil-9) in people with HPV Vaccine, run by Canadian Immunization Research Network at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- HPV Vaccine
- What is being tested?
- HPV nonavalent vaccine (Gardasil-9)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 23 Sep 2025to Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Immunosuppressed (at recruitment or when immunized).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jo-Ann Costa contact
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du CHU de Québec-Université Laval
Québec, Quebec, G1X4S9
Chantal Sauvageau, MD, 1+ 418 666-7000, chantal.sauvageau@inspq.qc.ca
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.
Little data on the immunogenicity (antibody production) and long-term efficacy of a single dose of the vaccine are available, particularly in boys.
Read more
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.
Read the 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
- Being tested
- HPV nonavalent vaccine (Gardasil-9)
- Keywords
- HPV, Vaccination, Schedule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV nonavalent vaccine (Gardasil-9)Biological
One dose HPV nonavalent vaccine
| Study group | Role | What they receive |
|---|---|---|
| One HPV vaccine dose received 6 years before recruitment | Experimental | Not described Receives: Biological: HPV nonavalent vaccine (Gardasil-9) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detectable antibodies
Proportion of participants with detectable antibodies
Measured: At recruitment (6 years post-one HPV vaccine dose)
Geometric mean concentrations
Geometric mean concentrations of antibodies
Measured: At recruitment (6 years post-one HPV vaccine dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start23 Sep 2025
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Canadian Immunization Research Network
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Chantal Sauvageau, MD, Principal investigator, INSPQ and Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07156084
- Sponsor's protocol ID
- CT-26 CIRN HPV 1 dose
- Acronym
- CIRN-HPV-ONE
- Status last verified
- Sep 2025
- First submitted
- 2 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Immune Response Six Years After One Dose of 9vHPV Vaccine Among Male and Female Students
- ClinicalTrials.gov ID
- NCT07156084
- Acronym / sponsor ID
- CIRN-HPV-ONE / CT-26 CIRN HPV 1 dose
- Conditions
- HPV Vaccine
- Keywords
- HPV, Vaccination, Schedule
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Canadian Immunization Research NetworkResearch network
- Study start
- 23 Sep 2025 (actual)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One HPV vaccine dose received 6 years before recruitment | Experimental | Biological: HPV nonavalent vaccine (Gardasil-9) |
Who may qualify
- Ages
- 15 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Immunosuppressed (at recruitment or when immunized).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV nonavalent vaccine (Gardasil-9)One dose HPV nonavalent vaccine | Biological | One HPV vaccine dose received 6 years before recruitment |
Primary outcome
Detectable antibodies
Time frame: At recruitment (6 years post-one HPV vaccine dose)
Proportion of participants with detectable antibodies
Geometric mean concentrations
Time frame: At recruitment (6 years post-one HPV vaccine dose)
Geometric mean concentrations of antibodies
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jo-Ann Costa contact
Chantal Sauvageau, MD principal investigator
INSPQ and Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HPV nonavalent vaccine (Gardasil-9) in people with HPV Vaccine, run by Canadian Immunization Research Network at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chantal Sauvageau, MD (418650-5115 ext. 6368, chantal.sauvageau@inspq.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detectable antibodies (time frame: At recruitment (6 years post-one HPV vaccine dose)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025; AzTrials last refreshed its copy on 7 Nov 2026.