Clinical trial · Observational
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
NCT06915779CI-TRIAL-00088278completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Cervical Dysplasia | Cervical Intraepithelial Neoplasia | ALIAS | 0.90 |
| Genital Warts | Condyloma Acuminatum | ALIAS | 0.90 |
| Human Immunodeficiency Virus | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Study Population
- description
- 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.
Primary outcomes (1)
- measure
- Primary Objective
- timeFrame
- 96 month post-vaccination regimen
- description
- To measure the antibody response to each genotype contained in the qHPV vaccine to 96 months post-vaccination regimen.
Secondary outcomes (3)
- measure
- Secondary Objective #1
- timeFrame
- 96 month post-vaccination regimen
- description
- To determine the incidence rate and nature of 'breakthrough' HPV incidence and persistent (2 sequential positive HPV DNA in \> 6 months) infections of vaccine - non-vaccine-containing high-risk types.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 11 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Enrolled in CTN 236 study, phase 1 * Able to give fully informed consent or assent Exclusion Criteria: * Did not receive at least one vaccination via CTN 236, phase 1 * Cannot provide fully informed consent or assent
References
Publications (0)
Data not yet available
No reference posted for this study.