Status:
COMPLETED
A Cohort Study to Assess Sustained Immunogenicity to qHPV Vaccine Among HIV-infected Girls and Boys Age 9-14 Years
Lead Sponsor:
Kenya Medical Research Institute
Collaborating Sponsors:
University of Washington
Merck Sharp & Dohme LLC
Conditions:
Human Papillomavirus
HIV-1 Infection
Eligibility:
All Genders
9-14 years
Brief Summary
The purpose of this study is to determine sustained immunogenicity of the quadrivalent vaccine 'Gardasil', 48 months after initial vaccination, among HIV-1 infected boys and girls age 9-14 years. This...
Detailed Description
HIV-infected individuals bear a disproportionate disease burden of HPV-related diseases suggesting more rapid progression from HPV acquisition to malignancy. HIV infected women have a 2-22 fold increa...
Eligibility Criteria
Inclusion
- HIV-infected
- age 9-14 years
- guardian/parental consent
Exclusion
- Participants will be excluded if they
- are severely ill as defined by Karnofsky \<70
- have a diagnosis of malignancy
- on-going febrile illness (temperature ≥37.8°C), including active treatment for an opportunistic infection
- have received systemic corticosteroids within prior one year
- have received inactivated vaccine within prior 2 weeks, or live attenuated vaccine within prior 6 weeks
- have history of allergy to any products included in the HPV vaccine
- have received any of blood derivatives within prior 6 months
- are pregnant
- lack parental consent and/or parent declines to provide assent
Key Trial Info
Start Date :
December 15 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01446718
Start Date
December 15 2014
End Date
June 30 2018
Last Update
July 5 2019
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