Román, Victor Raúl Gómez2; Jensen, Kristoffer Jarlov2; Jensen, Sanne Skov2; Leo-Hansen, Christian2; Jespersen, Sanne5; Té, David da Silva2; Rodrigues, Candida Medina2; Janitzek, Christoph Mikkel2; Vinner, Lasse2; Katzenstein, Terese Lea2; Andersen, Peter3; Kromann, Ingrid2; Andreasen, Lars Vibe4; Karlsson, Ingrid2; Fomsgaard, Anders2
1 Department of Clinical Medicine - Department of Infectious Diseases, Department of Clinical Medicine, Health, Aarhus University2 unknown3 Vaccine Research and Development, Statens Serum Institut4 Department of Integrated Pest Management, Faculty of Agricultural Sciences, Aarhus University, Aarhus University5 Department of Clinical Medicine - Department of Infectious Diseases, Department of Clinical Medicine, Health, Aarhus University
Safety, Immunogenicity, and Feasibility in Guinea-Bissau
We have designed a therapeutic HIV-1 vaccine concept based on peptides together with the adjuvant CAF01. Peptides represented 15 HLA-supertype-restricted subdominant and conserved CD8 T cell epitopes and three CD4 T-helper cell epitopes. In this phase I clinical trial, safety and immunogenicity were assessed in untreated HIV-1-infected individuals in Guinea-Bissau, West Africa. Twenty-three HIV-1-infected individuals were randomized to receive placebo (n=5) or vaccine (n=18). Safety was appraised by clinical follow-up combined with monitoring of biochemistry, hematology, CD4 T cell counts, and HIV-1 viral loads. T cell immunogenicity was monitored longitudinally by interferon (IFN)-γ ELISpot. New vaccine-specific T cell responses were induced in 6/14 vaccinees for whom ELISpot data were valid. CD4 T cell counts and viral loads were stable. The study shows that therapeutic immunization is feasible and safe in Guinea-Bissau and that it is possible to redirect T cell immunity with CAF01-adjuvanted HIV-1 peptide vaccine during untreated HIV-1 infection in some patients. However, relatively few preexisting and vaccine-induced HIV-1 T cell responses to CD8 T cell epitopes were detected against HIV-1 using IFN-γ ELISpot in this chronically infected African population.
Aids Research and Human Retroviruses, 2013, Vol 29, Issue 11, p. 1504-12