Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials

• ClinicalTrials.gov Identifier: NCT00789789
• Recruitment Status: Terminated
• First Posted: November 13, 2008
• Last Update Posted: June 1, 2017
• Sponsor: ANRS, Emerging Infectious Diseases
• Information provided by (Responsible Party): ANRS, Emerging Infectious Diseases

Study Description

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.

Condition or disease
HIV Infection; HIV Seronegativity

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 488 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Cohort Study of Volunteers That Have Participated to Preventive HIV-1 Vaccine Trials
• Study Start Date: December 2008
• Actual Primary Completion Date: September 2016
• Actual Study Completion Date: September 30, 2016

Groups and Cohorts

Group/Cohort
1

Outcome Measures

Primary Outcome Measures :

1. 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. [ Time Frame: once a year ]

Secondary Outcome Measures :

1. Evaluation of HIV serologic status by two ELISA tests and Western blot test ( only if ELISA is positive). [ Time Frame: once a year ]
2. 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. [ Time Frame: once a year ]
3. Incidence of HIV infection (frequency, description of contamination). [ Time Frame: once a year ]

Biospecimen Retention:   Samples With DNA

Blood specimen collection (serum, plasma and whole blood)

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

healthy volunteers.

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

Contacts and Locations

Locations

France

CIC Cochin Pasteur, hôpital Cochin

Paris, France, 75679

Sponsors and Collaborators

ANRS, Emerging Infectious Diseases

Investigators

• Principal Investigator: Odile LAUNAY, MD, PhD; CIC Cochin Pasteur, Hôpital Cochin, Paris, France
• Study Chair: Laurence MEYER, MD, PhD; INSERM SC-10-US019, Villejuif, France

More Information

• Responsible Party: ANRS, Emerging Infectious Diseases
• ClinicalTrials.gov Identifier: NCT00789789
• Other Study ID Numbers: 2007-002219-14; ANRS COV1 COHVAC
• First Posted: November 13, 2008
• Last Update Posted: June 1, 2017
• Last Verified: May 2017

Keywords provided by ANRS, Emerging Infectious Diseases:

Cohort; HIV uninfected volunteers; HIV preventive vaccine; Long term safety

Additional relevant MeSH terms:

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