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.
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.
Jaoko
Walter
W
Kenya AIDS Vaccine Initiative (KAVI), University of Nairobi, Department of Medical Microbiology, P.O. Box 19676, Nairobi 00202, Kenya. wjaoko@kaviuon.org
Nakwagala
Frederick N
FN
Anzala
Omu
O
Manyonyi
Gloria Omosa
GO
Birungi
Josephine
J
Nanvubya
Annet
A
Bashir
Farah
F
Bhatt
Kirana
K
Ogutu
Hilda
H
Wakasiaka
Sabina
S
Matu
Lucy
L
Waruingi
Wambui
W
Odada
Jane
J
Oyaro
Micah
M
Indangasi
Jackton
J
Ndinya-Achola
Jeckonia
J
Konde
Carol
C
Mugisha
Emmanuel
E
Fast
Patricia
P
Schmidt
Claudia
C
Gilmour
Jill
J
Tarragona
Tony
T
Smith
Carol
C
Barin
Burc
B
Dally
Len
L
Johnson
Bruce
B
Muluubya
Andrew
A
Nielsen
Leslie
L
Hayes
Peter
P
Boaz
Mark
M
Hughes
Peter
P
Hanke
Tomás
T
McMichael
Andrew
A
Bwayo
Job
J
Kaleebu
Pontiano
P
D016915:AIDS Vaccines / Q000009:adverse effects* / Q000276:immunology*; D000328:Adult; D018984:Epitopes, T-Lymphocyte / Q000235:genetics / Q000276:immunology; D005260:Female; D005434:Flow Cytometry; D005822:Genetic Vectors; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007371:Interferon-gamma / Q000096:biosynthesis; D007630:Kenya; D007963:Leukocytes, Mononuclear / Q000276:immunology; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D010957:Plasmids; D014454:Uganda; D019444:Vaccines, DNA / Q000235:genetics / Q000276:immunology*; D014616:Vaccinia virus / Q000235:genetics; D054301:gag Gene Products, Human Immunodeficiency Virus / Q000235:genetics / Q000276:immunology
D016915:AIDS Vaccines; D018984:Epitopes, T-Lymphocyte; D010919:Placebos; D019444:Vaccines, DNA; D054301:gag Gene Products, Human Immunodeficiency Virus; D007371:Interferon-gamma