HIV Infections, HIV Seronegativity
Conditions
Keywords
HIV Vaccines, HIV Seronegativity
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 safety and immunogenicity of LIPO-4 vaccine (HIV lipopeptides including 4 peptides from Gag, Pol, RT and Nef HIV-1 proteins, each peptide linked to TT) intradermally (ID) compared to IM administration.
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 healthy adult volunteers, 21-55 years old, all belonging to the Volunteers for a Vaccine network set up by ANRS, were randomized to receive at weeks 0, 4, and 12, either 3 IM doses of 0.5 ml of LIPO-4 containing 500 µg of each peptide (n= 35 volunteers), or 3 ID doses of 0.1 ml, containing 100 µg of each peptide (n=33 volunteers). Total follow-up was 48 weeks. Safety was assessed clinically and by laboratory tests. Participants were given diary cards to record adverse events. HIV-1 immune responses were assessed by ELISPOT and lymphoproliferative assay at weeks 0, 2, 6, 14, 24, and 48
Interventions
BIOLOGICALLipopeptides LIPO-4
Sponsors
French National Agency for Research on AIDS and Viral Hepatitis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* HIV uninfected * Acceptable methods of contraception for females of reproductive potential * Good general health * Signed written inform consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical and biological safety (over or equal to degree two of a adverse event grading scale) of LIPO-4 by ID and IM routes during the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparaison of CD4 positive cells responses using | — |
| lymphoprolifération test and CD8 positive cells responses using the capacity of these cells to synthesize IFN following stimulation with peptides of interest (ELISPOT IFN test) following IM or ID administration at weeks 2, 6, 14, 24, and 48 | — |
Countries
France
Outcome results
None listed