Status:
COMPLETED
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
HIV Infections
HIV Seronegativity
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Intramuscular (IM) administration of HIV lipopeptide vaccines have been shown to be able to induce HIV-1-specific T cell-mediated immune responses. The objective of this trial was to evaluate the safe...
Detailed Description
Dose-sparing strategies that use intradermal (ID) delivery of vaccines may be one approach for improving a vaccines immunogenicity and reducing the cost of vaccines. In this study, 68 HIV-negative he...
Eligibility Criteria
Inclusion
- HIV uninfected
- Acceptable methods of contraception for females of reproductive potential
- Good general health
- Signed written inform consent
Exclusion
- Risk to be infected by HIV virus
- Uveitis, chronic lyme disease, active syphilis, active mycobacterial diseases or sarcoidosis
- Autoimmune disease or immunodeficiency
- Medical history of food allergy, Lyell's or Steven Johnson's disease, unstable asthma
- Active, generalized eczema or chronic urticaria
- Blood products within 2 months prior to first study vaccine administration
- HIV vaccines in prior HIV vaccine trial or participation in an immunomodulator study
- Vaccines within 30 days prior to first study vaccine administration
- Pregnant
- Long-term immunosuppressive or immunomodulator medications or within 6 months to first study vaccine administration
- Blood transfusion within 6 months to first study vaccine administration
- Treated with extracted pituitary hormones
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00121121
Start Date
July 1 2004
End Date
December 1 2005
Last Update
March 15 2007
Active Locations (1)
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1
Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
Paris, France, 75014