NCT04711265

Antibody Response to Prophylactic QHPV Vaccine at 48 Months Among HIV-infected Girls and Boys

A Longitudinal Cohort Study to Assess Sustained Immunogenicity up to 48 Months to Quadrivalent Human Papillomavirus Vaccine Among HIV-infected Girls and Boys Age 10-15 Years in Kenya

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 176 (actual)
• Sponsor: Kenya Medical Research Institute · Academic / Other
• Sex: All
• Age: 9 Years – 14 Years
• Healthy volunteers: —

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.

Conditions

• HPV Vaccine
• HPV Infection
• HIV-1-infection

Interventions

Type	Name	Description
DRUG	Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine	Intramuscular injection with 3 doses of QHPV

Timeline

• Start date: 2015-09-01
• Primary completion: 2018-11-01
• Completion: 2019-01-01
• First posted: 2021-01-15
• Last updated: 2021-01-15

Locations

1 site across 1 country: Kenya