Immunogenicity and Safety of HPV Vaccine in HIV-infected Pre-adolescent Girls and Boys in Kenya
The purpose of this study is to determine whether the quadrivalent vaccine 'Gardasil' is safe and effective when used by HIV-1 infected boys and girls age 9-14 years. This age range is within the World Health Organization (WHO) stipulated guidelines for national programs for the vaccine.
Biological: Gardasil vaccine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Immunogenicity and Safety of Quadrivalent HPV Vaccine Among HIV-1 Infected Pre Adolescent Boys and Girls in Kenya|
- immune response to vaccine specific HPV types [ Time Frame: 12 months ] [ Designated as safety issue: No ]antibody response to HPV type 6, 11, 16, 18 measured by cLIA
- Safety as measured by adverse event reporting [ Time Frame: through out the study ] [ Designated as safety issue: Yes ]adverse events attributed to vaccine. Immediate post vaccination adverse events detailed reports will be collected for 1st 14 days post vaccination
|Study Start Date:||May 2013|
|Estimated Study Completion Date:||December 2017|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
It is a single arm study, comparative group for analysis will use historical cohort data Gardasil Vaccine: three 0.5 mL intramuscular injections of 40/80/80/40 mcg/mL of suspended virus-like particles of human papillomavirus type 6,11,16 and 18. The second and third administered 1 and 6 months after the first.
Biological: Gardasil vaccine
0.5ml of intramuscular vaccine in three doses
Other Name: Gardasil
Human Papillomavirus, also simply called HPV, is known to cause cervical cancer among women and warts in the genital areas for both men and women among other cancers in the throat, anus and penis.
The HPV vaccine has been tested and shown to be effective in preventing infection with HPV types 16, 18, 6 and 11. HPV 16 and 18 cause 70% of cervical cancer and types 6 and 11 cause the majority of anogenital warts.
HIV-infected persons have a higher risk of getting warts and HPV related cancers and would benefit immensely from this vaccine. However, other vaccines such as the hepatitis B vaccine have been shown to require additional dosages to be effective among HIV-infected persons.
The investigators therefore propose to enroll 180 girls and boys in Kenya, age 9-14 years and give then the prescribed three doses of vaccine.
The study participants will be closely followed to determine if they suffer any side effects. The investigators shall also measure the response to vaccine at month 7 and 12, these responses will be compared to other data from cohorts of HIV-uninfected persons.
The total follow up time will be 12 months for each child.
Study Location: Partners in Prevention, Thika site
Please refer to this study by its ClinicalTrials.gov identifier: NCT01446718
|Thika Partners in Prevention|
|Thika, Central Province, Kenya|
|Principal Investigator:||Nelly R Mugo, MMed, MPH||Kenya Medical Research Institute (KEMRI)|