Clinical trial NCT00944879: Preparing for Adolescent HIV Vaccine Trials in South Africa:
Official title: Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Infection
HIV Infections
Keywords: HIV
vaccine
prevention
HPV
adolescents
Lead sponsor: Desmond Tutu HIV Centre
Sponsor class: OTHER
Collaborators: name: European and Developing Countries Clinical Trials Partnership (EDCTP)
name: Merck Sharp & Dohme LLC
First posted: 2009-07-23
Enrollment: 1400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: South African adolescents aged 12 to 17

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 HIV vaccine trial in adolescents.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment and retention
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Desmond Tutu HIV Centre
Study officials:
affiliation: Desmond Tutu HIV Centre
name: Linda-Gail Bekker, MBChB PhD
role: PRINCIPAL_INVESTIGATOR
References: