HIV-1-infection, HPV Infection, HPV Vaccine
Conditions
Keywords
HPV Vaccine, HIV infection, Adolescents, Africa
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.
Interventions
Intramuscular injection with 3 doses of QHPV
Sponsors
University of Washington
Merck Sharp & Dohme LLC
Kenya Medical Research Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Inclusion criteria
* 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
Exclusion criteria
* decline consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus Antibody Titers | 48 months | Geometric mean titers for HPV type -6, -11, -16 and -18 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Kenya
Outcome results
None listed