Preparing for Adolescent HIV Vaccine Trials in South Africa:
Preparing for Adolescent HIV Vaccine Trials in South Africa:
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.
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 trials. The study will allow for site capacity building in terms of recruiting and
 retaining an HIV-negative high-risk adolescent cohort, and assessing the acceptability of an
 STI vaccine to adolescents and their parents or guardians. Correlates of vaccine uptake,
 refusal, retention and attrition will be determined. In addition, the study will document the
 incidence of HIV, other sexually transmitted infections (STI's) and pregnancies and
 circumcisions in this age group. Different methods of assessing understanding in adolescents
 will be tested, to ensure that informed consent is being achieved. Experiences of privacy and
 confidentiality issues for adolescents in such research will be explored. Finally,
 psycho-social correlates of sexual risk and protective behaviour will be examined.

 The study is designed as a longitudinal cohort study with a self-selected intervention and
 control group. Adolescents and parents will be recruited through community outreach and
 invited to attend a Vaccine Discussion Group (VDG) to learn more about the HPV vaccine.
 Parental/ legal guardian consent and adolescent assent will be obtained prior to screening.
 After screening to ensure volunteers meet inclusion criteria, 1400 participants will be
 enrolled across seven sites. At this point, they will decide whether or not they want to
 receive the HPV vaccine. Those who do will receive three doses, at 0, 2 and 6 months. All
 participants will undergo HIV and pregnancy testing, receive risk reduction counseling and
 complete questionnaires at 0, 2, 6 and 9 months. Recruitment and retention will be monitored
 and data as described above will be collected throughout the course of the study.
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