Preparing for Adolescent HIV Vaccine Trials in South Africa:

NCT00944879 | Unknown DMC

• 2 other identifiers: 35384CT.2006.33111.004
• Study Type: observational
• Target: 1,400
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infection; HIV Infections

Keywords

HIV; vaccine; prevention; HPV; adolescents

Outcome Measures

Primary Outcomes (1)

• Recruitment and retention

  9 months

Study Arms (2)

HPV vaccine

Those choosing to receive the HPV vaccine

no HPV vaccine

Those choosing not to receive the HPV vaccine

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

South African adolescents aged 12 to 17

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Desmond Tutu HIV Centre: lead
• European and Developing Countries Clinical Trials Partnership (EDCTP): collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Desmond Tutu HIV Centre

Cape Town, South Africa

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for HIV, syphilis and pregnancy testing

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Linda-Gail Bekker, MBChB PhD

  Desmond Tutu HIV Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 23, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: August 17, 2009

Record last verified: 2009-07

Locations

ZA (1)