Status:
COMPLETED
AIDS Vaccine Study Comparing Immunogenicity and Safety of 3 Doses of Lipopeptides Versus Placebo in Non Infected HIV Volunteers
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
HIV Infections
Eligibility:
All Genders
21-55 years
Phase:
PHASE2
Brief Summary
This study will test the safety and immune response to an experimental HIV vaccine, LIPO-5, in healthy volunteers. LIPO-5 contains 5 lipopeptides from gag, nef and pol corresponding to more than 50 ep...
Detailed Description
The aims of HIV lipopeptide vaccination approach are to improve cell mediated immune responses in order to obtain strong, long lasting and polyepitopic responses and to focus these responses on highly...
Eligibility Criteria
Inclusion
- Healthy volunteers selected by ANRS (French National Agency for Research on AIDS and Viral Hepatitis)
- For woman of child-bearing age: use of effective contraception
- Ability to sign informed consent
- Beneficiary subjects of social security regimen-- Hepatitis B, hepatitis C, HIV, HTLV1 infection and syphilis negative
- Hemoglobin over 12.5 g/dl for women and over 13.5 g/dl for men
Exclusion
- Previous participation in an HIV clinical trial
- Volunteers with risk to contract HIV infection during the trial
- Previous vaccination in the last month, and volunteers requiring vaccination during the trial
- Gift of blood in the last 2 months
- Eczema, urticaria
- Medical history of food allergy, Lyell or Stevens Johnson syndrome and aggravated asthma
- Previous (last 6 months) or ongoing administration of immunological treatment, chemotherapy, radiotherapy or corticosteroid
- Medical history of autoimmune disease
- Clinical or biological aftermath of previous disease
- Medical history of uveitis
- Transfusion in the last 6 months
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT00121758
Start Date
September 1 2004
End Date
December 1 2007
Last Update
June 6 2008
Active Locations (1)
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1
CIC de Vaccinologie Cochin Pasteur
Paris, France, 75014