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

French National Agency for Research on AIDS and Viral Hepatitis

Status and phase

Completed

Phase 1

Conditions

HIV Infections

HIV Seronegativity

Treatments

Biological: Lipopeptides LIPO-4

Study type

Interventional

Funder types

Other

Identifiers

NCT00121121

ANRS VAC16

Details and patient eligibility

About

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.

Full 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

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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