Clinical trial · Interventional
Effectiveness of the Q-HPV Vaccine 9-years Post Vaccination Among HIV Positive Adolescents
A Longitudinal Cohort Study to Assess Effectiveness and B-memory Response to the Quadrivalent HPV Vaccine 9 Years Post-vaccination Among HIV-Infected Boys and Girls Ages 9-14 Years in Kenya
- 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 risk for Human Papillomavirus (HPV) infection persists through an individual sexual life and duration of protection is critical to vaccine effectiveness in protection from oncogenic hrHPV infection. HIV-infected individuals have an increased risk for HPV infection, and persistent infection. Most vaccine efficacy data among HIV-infected adolescents is represented by immunogenicity data, and there is little published literature on vaccine effectiveness as assessed by persistent incident genital HPV infection. Investigators shall re-enroll a cohort of previously vaccinated HIV-infected girls and boys for assessment of genital HPV infection 9-years post initial 3 doses of vaccination with quadrivalent HPV vaccine at ages 9 to 14 years.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV Infection | — | UNRESOLVED | — |
| HPV Vaccination | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Quadrivalent HPV Vaccine
- description
- Gardasil® 0.5 mL administered intramuscularly in the deltoid or anterolateral area of the thigh
- interventionNames
- Drug: Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recombinant Vaccine
Primary outcomes (2)
- measure
- Persistent Genital HPV infection
- timeFrame
- Nine years after primary vaccination
- description
- Number of participants with incident persistent genital infection with the QHPV specific serotypes: -6, -11, -16 and -18 and additional 13 oncogenic HPV serotypes (31,33,35,39,45,51,52,56,58,59,66, 68,73)
- measure
- Sustained QHPV vaccine specific antibody titers
- timeFrame
- Nine years after primary vaccination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 25 Years
Show eligibility criteria text
Inclusion Criteria: * HIV-infected * enrolled previously and received received three doses of quadrivalent HPV- vaccine in 2014 Exclusion Criteria: * Decline re-enrollment * unable to provide informed consent * minor without parent or guardian consent
References
Publications (0)
Data not yet available