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

NCT ID: NCT04711265

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

176 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-01-31

Brief Summary

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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'.

Detailed Description

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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.

Conditions

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HPV Vaccine HPV Infection HIV-1-infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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

Intramuscular injection with 3 doses of QHPV

Intervention Type DRUG

Other Intervention Names

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QHPV vaccine

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Washington

OTHER

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Kenya Medical Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Nelly Rwamba Mugo

Senior Principal Clinical Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Partners in Health Research and Development

Thika, Kiambu County, Kenya

Site Status

Countries

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Kenya

Other Identifiers

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KENYAMRI

Identifier Type: -

Identifier Source: org_study_id

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