Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys
- Conditions
- HPV VaccineHPV InfectionHIV-1-infection
- Registration Number
- NCT04711265
- Lead Sponsor
- Kenya Medical Research Institute
- Brief Summary
Longitudinal observational cohort study and extension of the MISP ID: 38406 'immunogenicity and safety of quadrivalent human papillomavirus vaccine in HIV-infected pre-adolescent girls and boys in Kenya'.
- Detailed Description
We evaluated for persistence of HPV antibody by measuring titers to specific HPV types 6, 11, 16 and 18 at re-enrollment month 24 , 36 and 48 months in addition to month 7 and 12, after initial vaccination. This provided data for immunogenicity among HIV-infected children for approximately 48 months after initial vaccination. We assessed decline over study intervals in HPV type-specific antibodies.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
- receipt of 3 doses of QHPV vaccine
- participated in primary immunogenicity study
- consent/assent with parental consent for participants age <18 years
- willing to continue extended follow up for 36 months
- decline consent
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Human Papillomavirus Antibody Titers 48 months Geometric mean titers for HPV type -6, -11, -16 and -18
- Secondary Outcome Measures
Name Time Method HIV RNA viral load 48 months Impact of HIV RNA viral load on HPV antibody response
CD 4 cell count 48 months Impact of immune status on HPV antibody response
Trial Locations
- Locations (1)
Partners in Health Research and Development
🇰🇪Thika, Kiambu, Kenya