Preparing for Adolescent HIV Vaccine Trials in South Africa: (NCT00944879) | Clinical Trial Compass
UnknownNot Applicable
Preparing for Adolescent HIV Vaccine Trials in South Africa:
South Africa1,400 participantsStarted 2009-08
Plain-language 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 HIV vaccine trial in adolescents.
Who can participate
Age range12 Years – 17 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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