Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers

Study Overview
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Brief Summary
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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
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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

Official Title
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A Phase Ib Vaccine Trial Evaluating the Safety and Immunogenicity of HIV Lipopeptides by Two Administration Routes (Intramuscular And Intradermal) in Healthy Adult Volunteers. ANRS VAC16 Trial

Conditions
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HIV Infections, HIV Seronegativity

Intervention / Treatment
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* Biological: Lipopeptides LIPO-4


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Lipopeptides LIPO-4|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV Vaccines, HIV Seronegativity