Preparing for Adolescent HIV Vaccine Trials in South Africa: (CATSA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00944879
Recruitment Status : Unknown
Verified July 2009 by Desmond Tutu HIV Centre.
Recruitment status was:  Not yet recruiting
First Posted : July 23, 2009
Last Update Posted : August 17, 2009
European and Developing Countries Clinical Trials Partnership (EDCTP)
Merck Sharp & Dohme Corp.
Information provided by:
Desmond Tutu HIV Centre

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.

Condition or disease
HIV Infection HIV Infections

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.

Study Type : Observational
Estimated Enrollment : 1400 participants
Observational Model: Cohort
Time Perspective: Prospective
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 Start Date : August 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

HPV vaccine
Those choosing to receive the HPV vaccine
no HPV vaccine
Those choosing not to receive the HPV vaccine

Primary Outcome Measures :
  1. Recruitment and retention [ Time Frame: 9 months ]

Biospecimen Retention:   Samples Without DNA
Blood for HIV, syphilis and pregnancy testing

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
South African adolescents aged 12 to 17

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00944879

South Africa
Desmond Tutu HIV Centre Not yet recruiting
Cape Town, South Africa
Contact: Melissa L Wallace, MSc, PhD    +27 21 650 6960   
Contact: Agnes Ronan, RGN, MBA    +27 21 650 6962   
Principal Investigator: Linda-Gail Bekker, MBChB, PhD         
Sponsors and Collaborators
Desmond Tutu HIV Centre
European and Developing Countries Clinical Trials Partnership (EDCTP)
Merck Sharp & Dohme Corp.
Principal Investigator: Linda-Gail Bekker, MBChB PhD Desmond Tutu HIV Centre

Responsible Party: Professor Linda-Gail Bekker, Desmond Tutu HIV Centre Identifier: NCT00944879     History of Changes
Other Study ID Numbers: 35384
First Posted: July 23, 2009    Key Record Dates
Last Update Posted: August 17, 2009
Last Verified: July 2009

Keywords provided by Desmond Tutu HIV Centre:

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Communicable Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Immunologic Factors
Physiological Effects of Drugs