Back to resultsSafety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
Primary Purpose
HIV Infections, HIV Seronegativity
Status
Completed
Phase
Phase 1
Locations
France
Study Type
Interventional
Intervention
Lipopeptides LIPO-4
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV Vaccines, HIV Seronegativity
Eligibility Criteria
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
Sites / Locations
- Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00121121
First Posted
July 13, 2005
Last Updated
March 14, 2007
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
1. Study Identification
Unique Protocol Identification Number
NCT00121121
Brief Title
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, HIV Seronegativity
Keywords
HIV Vaccines, HIV Seronegativity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Lipopeptides LIPO-4
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Comparaison of CD4 positive cells responses using
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Odile Launay, MD
Organizational Affiliation
Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Christine Durier, MD
Organizational Affiliation
Inserm SC10
Official's Role
Study Director
Facility Information:
Facility Name
Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
17712402
Citation
Launay O, Durier C, Desaint C, Silbermann B, Jackson A, Pialoux G, Bonnet B, Poizot-Martin I, Gonzalez-Canali G, Cuzin L, Figuereido S, Surenaud M, Ben Hamouda N, Gahery H, Choppin J, Salmon D, Guerin C, Bourgault Villada I, Guillet JG; ANRS VAC16 Study Group. Cellular immune responses induced with dose-sparing intradermal administration of HIV vaccine to HIV-uninfected volunteers in the ANRS VAC16 trial. PLoS One. 2007 Aug 22;2(8):e725. doi: 10.1371/journal.pone.0000725.
Results Reference
derived
Learn more about this trial
Safety of Intradermal Versus Intramuscular Administration of HIV Lipopeptides in HIV Uninfected Adult Volunteers
We'll reach out to this number within 24 hrs