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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00121121
• Other study ID #: ANRS VAC16
• Status: Completed
• Phase: Phase 1
• First received: July 13, 2005
• Last updated: March 14, 2007
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2005
• Source: French National Agency for Research on AIDS and Viral Hepatitis
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• Lipopeptides LIPO-4

Locations

Country	Name	City	State
France	Hopital Cochin Centre Cochin-Pasteur d'Essais vaccinaux	Paris

Sponsors (1)

Lead Sponsor	Collaborator
French National Agency for Research on AIDS and Viral Hepatitis

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Comparaison of CD4 positive cells responses using
Secondary	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