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CompletedNCT04711265Updated Jan 15, 2021

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

An observational study in HPV Vaccine, HPV Infection and HIV-1-infection, sponsored by Kenya Medical Research Institute. Completed at 1 site in Kenya. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Kenya Medical Research Institute · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
176
Ages
9 Years to 14 Years
Sex
All
01

Study 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'.

Read the 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.

02

Conditions studied

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

Keywords

  • HPV Vaccine, HIV infection, Adolescents, Africa
03

In context

Infections

6,688 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 176 is below the median of 240 across 2,136 observational studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Kenya Medical Research Institute is the lead sponsor of 13 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • decline consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
176 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Interventions

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

    Intramuscular injection with 3 doses of QHPV

    Also known as: QHPV vaccine

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What researchers measure

Primary outcomes

  1. Human Papillomavirus Antibody Titers

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

    Time frame: 48 months

Secondary outcomes

  1. HIV RNA viral load

    Impact of HIV RNA viral load on HPV antibody response

    Time frame: 48 months

  2. CD 4 cell count

    Impact of immune status on HPV antibody response

    Time frame: 48 months

07

Study locations

1 site
  • Partners in Health Research and Development
    Thika, Kiambu, Kenya
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04711265
Lead sponsor
Kenya Medical Research Institute
Collaborators
University of Washington, Merck Sharp & Dohme LLC
Responsible party
Nelly Rwamba Mugo (Senior Principal Clinical Research Scientist, Kenya Medical Research Institute) — Principal investigator
First posted
Jan 15, 2021
Start date
Sep 2015
Primary completion
Nov 2018
Completion
Jan 2019
Last update
Jan 15, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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