Long Term Follow-up of HPV Vaccine in HIV (CTN 236)
Long Term Follow-up Study of CTN 236 - A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women
1 other identifier
observational
241
1 country
13
Brief Summary
The purpose of this extension study is to determine whether HPV antibody levels in HIV-positive girls and women will decline more rapidly and more significantly than in HIV-negative girls and women and if this decline is determined by HIV parameters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2021
CompletedFirst Submitted
Initial submission to the registry
March 31, 2025
CompletedFirst Posted
Study publicly available on registry
April 8, 2025
CompletedApril 8, 2025
March 1, 2025
5.8 years
March 31, 2025
March 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary Objective
To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post-vaccination regimen.
96 month post-vaccination regimen
Secondary Outcomes (3)
Secondary Objective #1
96 month post-vaccination regimen
Secondary Objective #2
96 month post-vaccination regimen
Secondary Objective #3
96 month post-vaccination regimen
Other Outcomes (2)
Exploratory Objective #1
96 month post-vaccination regimen
Exploratory Objective #2
96 month post-vaccination regimen
Study Arms (1)
Study Population
HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of quadrivalent HPV vaccine, will be offered participation on this study.
Eligibility Criteria
HIV positive girls and women (greater than, or equal to, age 11) attending the HIV treatment clinics in each of the 13 sites across Canada and who have enrolled in the original study, "A Study of an HPV VLP Vaccine in a Cohort of HIV Positive Girls and Women (CTN 236)" and received at least one dose of the quadrivalent HPV vaccine, will be offered participation in the study.
You may qualify if:
- Enrolled in CTN 236 study, phase 1
- Able to give fully informed consent or assent
You may not qualify if:
- Did not receive at least one vaccination via CTN 236, phase 1
- Cannot provide fully informed consent or assent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of British Columbialead
- CIHR Canadian HIV Trials Networkcollaborator
- Women's Health Research Institute of British Columbiacollaborator
- Canadian Institutes of Health Research (CIHR)collaborator
- BC Women's Hospital & Health Centrecollaborator
- Merck Canada Inc.collaborator
- University Health Network, Torontocollaborator
- McGill Universitycollaborator
- University of Saskatooncollaborator
- British Columbia Centre for Disease Controlcollaborator
- Vaccine Evaluation Center, Canadacollaborator
- British Columbia Cancer Agencycollaborator
Study Sites (13)
Oak Tree Clinic, BC Women's Hospital & Health Centre
Vancouver, British Columbia, V6H 3N1, Canada
AIDS Research Program & the John Ruedy Immunodeficience Clinic, St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6, Canada
Hamilton Health Sciences
Hamilton, Ontario, L8S 1A4, Canada
Infection & Immunology Clinic, Hotel Dieu
Kingston, Ontario, K7L 5G2, Canada
Children's Hospital of Eastern Ontario (CHEO)
Ottawa, Ontario, K1H 8L1, Canada
St. Michael's Hospital
Toronto, Ontario, M5C 1K2, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Maple Leaf Research
Toronto, Ontario, M5G 2N2, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
HIV Care Program
Windsor, Ontario, N8W 1E3, Canada
Centre de maternal et infantile sur le sida, CHU Sainte Justine
Montreal, Quebec, H3T 1C5, Canada
Chronic Viral Illness Service, Hopital Royal Victoria (McGill University)
Montreal, Quebec, H4A 3J1, Canada
CHUL and Mother-Child Center Soleil, Centre de Recherche en Infectiologie CHU de Quebec, (Universite Laval)
Québec, Quebec, G1V 4G2, Canada
Biospecimen
Cervical cytology and HPV DNA (liquid prep method) Gynecological swab for vaginal microbiota Serology for HPV antibodies Serology for HSV-2
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah M Money, MD, FRCSC
Dept. OB/GYN, University of British Columbia
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Vice Dean, Faculty of Medicine, Professor, Dept. OB/GYN
Study Record Dates
First Submitted
March 31, 2025
First Posted
April 8, 2025
Study Start
June 1, 2015
Primary Completion
March 30, 2021
Study Completion
March 30, 2021
Last Updated
April 8, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share