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Completed

NCT Number: NCT04711265

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

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'.

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Key information

Conditions

HPV Vaccine Blood-Borne Infections Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases HIV Infections HIV-1-infection HPV Infection Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Partners in Health Research and Development

Thika, Kiambu County, Kenya

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Intramuscular injection with 3 doses of QHPV

Other names: QHPV vaccine

Primary outcomes

  1. Human Papillomavirus Antibody Titers

    Time frame: 48 months

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

Secondary outcomes

  1. HIV RNA viral load

    Time frame: 48 months

    Impact of HIV RNA viral load on HPV antibody response

  2. CD 4 cell count

    Time frame: 48 months

    Impact of immune status on HPV antibody response

Sponsors and collaborators

Lead sponsor

Kenya Medical Research Institute

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • University of Washington

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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