Clinical trial NCT00789789: Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
Official title: Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: HIV Infection
HIV Seronegativity
Keywords: Cohort
HIV uninfected volunteers
HIV preventive vaccine
Long term safety
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2008-11-13
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy volunteers.

Brief summary: This cohort study should provide an exhaustive overview on long-term safety of various preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the ANRS network.

Detailed description: Since 1992, 16 phase I and II clinical trials have been performed by the French National Agency for Research on AIDS and Viral Hepatitis (ANRS) evaluating the safety of several HIV-1 vaccine candidates and their capacity to induce immune responses. The ANRS program has evaluated a recombinant HIV-1 envelope protein Rgp-160, canarypox ALVAC vectors, and mixtures of lipopeptides whose sequences represent CTL-epitopes of HIV-1 Gag, Pol and Nef proteins. Most of them have been administered intramuscularly but recently, mucosal immunization and intradermal route were used. Previously compiled in a published meta-analysis, safety studies were restricted to the duration of the trials.

ANRS establishes a cohort study in order to describe the long-term safety of preventive HIV-vaccines administered in phase I and II clinical trials to healthy volunteers of the "ANRS volunteer-network" in France and to gather clinical and biological data in a database and blood specimen collection which could be analysed in case of a long-term safety issue in ANRS vaccine trials or if pertinent, in other HIV vaccine trials ANRS COV1-COHVAC is a prospective, multicentric cohort study composed of participants in preventive HIV-vaccines phase I and II trials. All ANRS volunteers who ever received one dose of a candidate vaccine are eligible and those who are going to complete their participation to a clinical trial during the cohort study time.

The ANRS COV1-COHVAC project relies on a long-term follow-up of the cohort (at least 7 years after the end of the vaccine trial), that includes the retrospective and prospective collection of medical and biological data \[severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a candidate vaccine, are recorded\], blood specimen collections and psycho-behavioral evaluations (self-questionnaires and interviews) in order to collect data about consequences of participation and experience of possible HIV vaccine-induced seropositivity in such trials.

Of the ANRS "volunteer-network", 206 participants have been involved in the early trials and are actually eligible to participate in this cohort. Altogether with the more recent studies completed or in progress, the cohort will comprise at least 400 individuals in 2009.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers of the "ANRS volunteer network" who have received at least one dose of a vaccine candidate in a HIV preventive clinical trial.
* volunteers who have signed an informed consent

Exclusion Criteria:

* volunteers not covered by Health Insurance

Primary outcomes:
measure: Description of severe health events (grade 3-4), as well as neurological, ophtalmological, and immunological events (any grade), starting from the first injection of a HIV candidate vaccine.
timeFrame: once a year
Secondary outcomes:
measure: Evaluation of HIV serologic status by two ELISA tests and Western blot test ( only if ELISA is positive).
timeFrame: once a year
measure: Evaluation of psycho-behavioral consequences, associated to participation in a HIV preventive trial, on entourage, familial, professional and social relations, with a self-questionnaire and an interview with a clinician.
timeFrame: once a year
measure: Incidence of HIV infection (frequency, description of contamination).
timeFrame: once a year
Other outcomes:
Locations:
city: Paris
country: France
facility: CIC Cochin Pasteur, hôpital Cochin
Study officials:
affiliation: CIC Cochin Pasteur, Hôpital Cochin, Paris, France
name: Odile LAUNAY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM SC-10-US019, Villejuif, France
name: Laurence MEYER, MD, PhD
role: STUDY_CHAIR
References: