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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by Desmond Tutu HIV Centre.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Merck Sharp & Dohme Corp.
Information provided by:
Desmond Tutu HIV Centre
ClinicalTrials.gov Identifier:
NCT00944879
First received: July 20, 2009
Last updated: August 14, 2009
Last verified: July 2009
  Purpose

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
HIV Infection
HIV Infections

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Desmond Tutu HIV Centre:

Primary Outcome Measures:
  • Recruitment and retention [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood for HIV, syphilis and pregnancy testing


Estimated Enrollment: 1400
Study Start Date: August 2009
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
HPV vaccine
Those choosing to receive the HPV vaccine
no HPV vaccine
Those choosing not to receive the HPV vaccine

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

Ages Eligible for Study:   12 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

South African adolescents aged 12 to 17

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00944879

Locations
South Africa
Desmond Tutu HIV Centre Not yet recruiting
Cape Town, South Africa
Contact: Melissa L Wallace, MSc, PhD    +27 21 650 6960    melissa.wallace@hiv-research.org.za   
Contact: Agnes Ronan, RGN, MBA    +27 21 650 6962    agnes.ronan@hiv-research.org.za   
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.
Investigators
Principal Investigator: Linda-Gail Bekker, MBChB PhD Desmond Tutu HIV Centre
  More Information

Additional Information:
No publications provided

Responsible Party: Professor Linda-Gail Bekker, Desmond Tutu HIV Centre
ClinicalTrials.gov Identifier: NCT00944879     History of Changes
Other Study ID Numbers: 35384, CT.2006.33111.004
Study First Received: July 20, 2009
Last Updated: August 14, 2009
Health Authority: South Africa: National Health Research Ethics Council

Keywords provided by Desmond Tutu HIV Centre:
HIV
vaccine
prevention
HPV
adolescents

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
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

ClinicalTrials.gov processed this record on July 20, 2014