Immune Response and Safety Study of Human Papillomavirus (HPV) Vaccine in HIV-infected Pre-adolescent in Kenya
The purpose of this study is to determine if the quadrivalent HPV vaccine 'Gardasil' is effective in eliciting a protective immune response among HIV-1 infected adolescents girls and boys age 9-14 years comparable to historical cohorts of HIV-1 uninfected women. The study will also determine if this response, differs by the degree of immunosuppression.
The study will also determine the safety and tolerability of the 'Gardasil' vaccine among HIV-1 infected boys and girls age 9-14.
Biological: Quadrivalent HPV Vaccine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of Quadrivalent Human Papillomavirus Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya|
- Antibody titre to HPV virus like particles as determined by the quadrivalent HPV competitive Luminex immunoassay (cLIA) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]The purpose of the cLIA is to detect antibody to HPV virus like particles before and after vaccination and is specific to HPV types.
- To correlate the immune response, as measured by antibody titers, with the degree of immunosuppression. [ Time Frame: 12 Months ] [ Designated as safety issue: No ]Most of the HIV-Infected boys and girls will be on HAART and thus have achieved partial immune reconstitution. However, nadir pre-HAART CD4 and WHO HIV disease stage as indicators of past immunosuppression, enrollment plasma HIV levels as an indicator of viral control on HAART, and enrollment CD4 compared to nadir CD4 as an indicator of immune reconstitution, may correlate with HPV vaccine immune response as measured by HPV antibody titers at months 7 and 12 post vaccination.
- To assess the safety and tolerability of the quadrivalent HPV vaccine (Gardasil) in boys and girls age 9-14 years in Kenya. [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
The vaccine report card will be utilized to record immediate post vaccine events for a period of 14 days after each vaccine dose.
Adverse events reports will be gathered through out the study period and categorized as Severe adverse Events (SAEs) and Adverse Events (SAEs).
All SAEs will be reported to the regulatory authorities within a stipulated time limit
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Experimental: Gardasil, Quadrivalent HPV Vaccine
Injection of 0.5mls HPV Gardasil Quadrivalent Vaccine administered at enrollment, month 2 and month 6.
Gardasil, is a Quadrivalent HPV Vaccine which has been tested to have high efficacy against HPV 6,11,16 and 18.
Biological: Quadrivalent HPV Vaccine
Intramuscular injections of 0.5 mls 'Gardasil' at enrollment, month 2 and month 6 visits the study has one study arm and the comparative data will be from historical cohorts
Other Name: Gardasil
Human Papillomavirus (HPV) is a common sexually transmitted infection, with more than 50% of young women infected within few years of initiatiing sexual activity. Persistent infection with high risk HPV types is known to cause cervical cancer among other tumors and genital warts. Cervical cancer and its precancerous lesions, genital warts are more common among HIV-1 infected individuals, among whom, cancer occurs at an earlier age and progresses more quickly.
The HPV 'Gardasil'vaccine has been tested widely among HIV-1 negative persons demonstrating high efficacy and safety profiles, it is widely registered for use across continents. However, there is minimal data in HIV-1 infected persons.
For many immunizations, HIV-1 infected persons experience lower immune responses compared to HIV-uninfected persons.
The investigators therefore propose to conduct a prospective study of the quadrivalent HPV 'Gardasil' vaccine among pre adolescent HIV infected girls and boys age 9-14 years in Kenya to extend current understanding f safety and immunogenicity.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998178
|Partners in Prevention|
|Thika, Kiambu, Kenya|
|Principal Investigator:||Nelly R. Mugo, MbCHB, MPH||Kenyatta National Hospital|