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

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

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