HIV-1-infection Clinical Trial
Official 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
NCT number | NCT04711265 |
Other study ID # | KENYAMRI |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2015 |
Est. completion date | January 2019 |
Verified date | January 2021 |
Source | Kenya Medical Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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'.
Status | Completed |
Enrollment | 176 |
Est. completion date | January 2019 |
Est. primary completion date | November 2018 |
Accepts healthy volunteers | |
Gender | All |
Age group | 9 Years to 14 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Kenya | Partners in Health Research and Development | Thika | Kiambu |
Lead Sponsor | Collaborator |
---|---|
Kenya Medical Research Institute | Merck Sharp & Dohme Corp., University of Washington |
Kenya,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Human Papillomavirus Antibody Titers | Geometric mean titers for HPV type -6, -11, -16 and -18 | 48 months | |
Secondary | HIV RNA viral load | Impact of HIV RNA viral load on HPV antibody response | 48 months | |
Secondary | CD 4 cell count | Impact of immune status on HPV antibody response | 48 months |
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