Immunogenicity and Safety of Quadrivalent HPV Vaccine Among HIV-1 Infected Pre Adolescent Boys and Girls
Phase 4
9 Years
14 Years
9 Years
14 Years
Not Enrolling
Both
Human Papillomavirus, HIV-1 Infection
Both
Human Papillomavirus, HIV-1 Infection
Trial Information
Immunogenicity and Safety of Quadrivalent HPV Vaccine Among HIV-1 Infected Pre Adolescent Boys and Girls
Inclusion Criteria:
- HIV-infected
- age 9-14 years
- guardian/parental consent
Exclusion Criteria:
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
immune response to vaccine specific HPV types
Outcome Description:
antibody response to HPV type 6, 11, 16, 18 measured by cLIA
Outcome Time Frame:
12 months
Safety Issue:
No
Authority:
Kenya: Pharmacy and Poisons Board
Study ID:
(MISP)IISP 38406
NCT ID:
NCT01446718
Start Date:
January 2012
Completion Date:
December 2014
Related Keywords:
- Human Papillomavirus
- HIV-1 Infection
- quadrivalent vaccine
- Human Papillomavirus
- HIV Infections
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