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

Preparing for Adolescent HIV Vaccine Trials in South Africa: a Multi-centre Study to Evaluate Acceptability of the HPV Vaccine in Adolescents

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.

Study Overview

• Status: Unknown
• Conditions: HIV Infections; HIV Infection

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
• Enrollment (Anticipated): 1400

Contacts and Locations

Study Locations

• South Africa
  • Cape Town, South Africa
    • Desmond Tutu HIV Centre
    • Contact: Melissa L Wallace, MSc, PhD; Phone Number: +27 21 650 6960; Email: melissa.wallace@hiv-research.org.za
    • Contact: Agnes Ronan, RGN, MBA; Phone Number: +27 21 650 6962; Email: agnes.ronan@hiv-research.org.za

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

South African adolescents aged 12 to 17

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HPV vaccine; Those choosing to receive the HPV vaccine
no HPV vaccine; Those choosing not to receive the HPV vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recruitment and retention	9 months

Collaborators and Investigators

• Sponsor: Desmond Tutu HIV Centre
• Collaborators: Merck Sharp & Dohme LLC; European and Developing Countries Clinical Trials Partnership (EDCTP)
• Investigators: Principal Investigator: Linda-Gail Bekker, MBChB PhD, Desmond Tutu HIV Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): February 1, 2011
• Study Completion (Anticipated): February 1, 2011

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 22, 2009
• First Posted (Estimate): July 23, 2009

Study Record Updates

• Last Update Posted (Estimate): August 17, 2009
• Last Update Submitted That Met QC Criteria: August 14, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: HIV; vaccine; prevention; adolescents; HPV
• Additional Relevant MeSH Terms: Pathologic Processes; RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Slow Virus Diseases; HIV Infections; Infections; Communicable Diseases; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: 35384; CT.2006.33111.004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No