Status:
UNKNOWN
Preparing for Adolescent HIV Vaccine Trials in South Africa:
Lead Sponsor:
Desmond Tutu HIV Centre
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Merck Sharp & Dohme LLC
Conditions:
HIV Infection
HIV Infections
Eligibility:
All Genders
12-17 years
Brief Summary
This study will use the licensed HPV vaccine, Gardasil, as a surrogate for an HIV vaccine, in order to explore some of the ethico-legal,psycho-social and logistical challenges involved in running an H...
Detailed Description
This study will use the licensed HPV vaccine, an alternative STI vaccine, as a proxy for an HIV vaccine and thereby identify potential challenges to the inclusion of adolescents in HIV prevention tria...
Eligibility Criteria
Inclusion
- Youth age 12-17 years
- For 12-15 year olds - no sexual risk criteria
- For 16-17 year olds (the age of lawful consent to sex in South Africa): sexually active (ever had sexual intercourse)
- Willing to participate in HIV testing and counseling
- Willing and able to assent to study
- Parent or legal guardian willing to provide written consent
- HIV-negative serostatus at screening and enrolment
- Females must have a negative pregnancy test at screening/enrolment
- Females must not be breastfeeding
- Additional inclusion criteria for those accepting HPV vaccination:
- No HPV immunizations
- Females should agree to avoid pregnancy through to the end of the study and to take contraceptives throughout the study (access provided)
Exclusion
- Exclusion criteria for those accepting HPV vaccination:
- Presence of any serious illness requiring treatment with systemic medications, excluding short course oral steroids or inhaled steroid treatment for asthma
- Contra-indication to vaccination, such as bleeding disorder
- Previous allergic reaction to any vaccines or to constituents of these vaccines (yeast, thimerosal or aluminum)
- Current immunomodulator therapy
- Receipt of immunosuppressor therapy (more than 10mg/day of prednisone or equivalent for \>1 week) in the 6 months preceding enrollment date
- Receipt of any vaccine within two weeks preceding enrollment date
Key Trial Info
Start Date :
August 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2011
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT00944879
Start Date
August 1 2009
End Date
February 1 2011
Last Update
August 17 2009
Active Locations (1)
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1
Desmond Tutu HIV Centre
Cape Town, South Africa