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NCT04711265 Clinical Trial

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

HIV-1-infection Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04711265
Other study ID # KENYAMRI
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date January 2019

Study information
Verified date January 2021
Source Kenya Medical Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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'.

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 information / eligibility
Status Completed
Enrollment 176
Est. completion date January 2019
Est. primary completion date November 2018
Accepts healthy volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Kenya Partners in Health Research and Development Thika Kiambu

Sponsors (3)
Lead Sponsor Collaborator
Kenya Medical Research Institute Merck Sharp & Dohme Corp., University of Washington

Country where clinical trial is conducted

Kenya, 

Outcome
Type Measure Description Time frame Safety issue
Primary Human Papillomavirus Antibody Titers Geometric mean titers for HPV type -6, -11, -16 and -18 48 months
Secondary HIV RNA viral load Impact of HIV RNA viral load on HPV antibody response 48 months
Secondary CD 4 cell count Impact of immune status on HPV antibody response 48 months
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