Clinical trial NCT00121121: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: HIV Vaccines
HIV Seronegativity
Lead sponsor: French National Agency for Research on AIDS and Viral Hepatitis
Sponsor class: OTHER_GOV
First posted: 2005-07-21
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: 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 outcomes:
measure: Comparaison of CD4 positive cells responses using
measure: 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
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux
Study officials:
affiliation: Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux
name: Odile Launay, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inserm SC10
name: Christine Durier, MD
role: STUDY_DIRECTOR
References:
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.