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

NCT ID: NCT00121121

Last Updated: 2007-03-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-12-31

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

Conditions

HIV Infections; HIV Seronegativity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Interventions

Lipopeptides LIPO-4

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Odile Launay, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Cochin Paris, Centre Cochin-Pasteur d'essais vaccinaux

Christine Durier, MD

Role: STUDY_DIRECTOR

Inserm SC10

Locations

Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 17712402 (View on PubMed)

Other Identifiers

ANRS VAC16

Identifier Type: -

Identifier Source: org_study_id