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

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'.

Study Overview

• Status: Completed
• Conditions: HPV Infection; HPV Vaccine; HIV-1-infection
• Intervention / Treatment: Drug: Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine

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.

• Study Type: Observational
• Enrollment (Actual): 176

Contacts and Locations

Study Locations

• Kenya
  • Kiambu
    • Thika, Kiambu, Kenya
      • Partners in Health Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 14 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

HIV-1 infected boys and girls who had received 3 doses of QHPV vaccine

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papillomavirus Antibody Titers	Geometric mean titers for HPV type -6, -11, -16 and -18	48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HIV RNA viral load	Impact of HIV RNA viral load on HPV antibody response	48 months
CD 4 cell count	Impact of immune status on HPV antibody response	48 months

Collaborators and Investigators

• Sponsor: Kenya Medical Research Institute
• Collaborators: Merck Sharp & Dohme LLC; University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: December 8, 2020
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: HPV Vaccine, HIV infection, Adolescents, Africa
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Tumor Virus Infections; Infections; Communicable Diseases; Papillomavirus Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: KENYAMRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No