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

Kenya Medical Research Institute176 enrolled

Overview

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'.

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.

Study Type

OBSERVATIONAL

Enrollment

176

Conditions

HPV Vaccine HPV Infection HIV-1-infection

Interventions

Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle VaccineDRUG

Intramuscular injection with 3 doses of QHPV

Eligibility

Sex: ALLMin age: 9 YearsMax age: 14 Years

Medical Language ↔ Plain English

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

Locations (1)

Partners in Health Research and Development

Thika, Kiambu County, Kenya

Outcomes

Primary Outcomes

Human Papillomavirus Antibody Titers

Geometric mean titers for HPV type -6, -11, -16 and -18

Time frame: 48 months

Secondary Outcomes

HIV RNA viral load

Impact of HIV RNA viral load on HPV antibody response

Time frame: 48 months

CD 4 cell count

Impact of immune status on HPV antibody response

Time frame: 48 months

Data from ClinicalTrials.gov

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