Safety and Immunogenicity of Recombinant Low-Dosage HIV-1 A Vaccine Candidates Vectored by Plasmid pTHr DNA or Modified Vaccinia Virus Ankara (MVA) in Humans in East Africa
03/2008
Journal Article
Authors:
W, J.;
FN, N.;
O, A.;
G, O.Manyonyi;
J, B.;
A, N.;
F, B.;
K, B.;
H, O.;
S, W.;
L, M.;
W, W.;
J, O.;
M, O.;
J, I.;
J, N.A.;
C, K.;
, ;
Smith, C.;
Barin, B.;
Dally, L.;
, ;
Kaleebu, P.
Secondary:
Vaccine
Volume:
26
Pagination:
2788-2795
URL:
http://www.ncbi.nlm.nih.gov/pubmed/18440674
Keywords:
Adult; AIDS Vaccines; Epitopes- T-Lymphocyte; Female; Flow cytometry; gag Gene Products-Human Immunodeficiency Virus; Genetic Vectors; HIV-1; Interferon-gamma; Kenya; Leukocytes- Mononuclear; Male; Placebos; Plasmids; Uganda; Vaccines-DNA; Vaccinia virus
Abstract:
The safety and immunogenicity of plasmid pTHr DNA, modified vaccinia virus Ankara (MVA) human immunodeficiency virus type 1 (HIV-1) vaccine candidates were evaluated in four Phase I clinical trials in Kenya and Uganda. Both vaccines, expressing HIV-1 subtype A gag p24/p17 and a string of CD8 T-cell epitopes (HIVA), were generally safe and well-tolerated. At the dosage levels and intervals tested, the percentage of vaccine recipients with HIV-1-specific cell-mediated immune responses, assessed by a validated ex vivo interferon gamma (IFN-gamma) ELISPOT assay and Cytokine Flow Cytometry (CFC), did not significantly differ from placebo recipients. These trials demonstrated the feasibility of conducting high-quality Phase 1 trials in Africa.
