title: 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.
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.
authors.affiliation: Kenya AIDS Vaccine Initiative (KAVI), University of Nairobi, Department of Medical Microbiology, P.O. Box 19676, Nairobi 00202, Kenya. wjaoko@kaviuon.org
authors.forename: Walter
authors.initials: W
authors.lastname: Jaoko
authors.forename: Frederick N
authors.initials: FN
authors.lastname: Nakwagala
authors.forename: Omu
authors.initials: O
authors.lastname: Anzala
authors.forename: Gloria Omosa
authors.initials: GO
authors.lastname: Manyonyi
authors.forename: Josephine
authors.initials: J
authors.lastname: Birungi
authors.forename: Annet
authors.initials: A
authors.lastname: Nanvubya
authors.forename: Farah
authors.initials: F
authors.lastname: Bashir
authors.forename: Kirana
authors.initials: K
authors.lastname: Bhatt
authors.forename: Hilda
authors.initials: H
authors.lastname: Ogutu
authors.forename: Sabina
authors.initials: S
authors.lastname: Wakasiaka
authors.forename: Lucy
authors.initials: L
authors.lastname: Matu
authors.forename: Wambui
authors.initials: W
authors.lastname: Waruingi
authors.forename: Jane
authors.initials: J
authors.lastname: Odada
authors.forename: Micah
authors.initials: M
authors.lastname: Oyaro
authors.forename: Jackton
authors.initials: J
authors.lastname: Indangasi
authors.forename: Jeckonia
authors.initials: J
authors.lastname: Ndinya-Achola
authors.forename: Carol
authors.initials: C
authors.lastname: Konde
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Mugisha
authors.forename: Patricia
authors.initials: P
authors.lastname: Fast
authors.forename: Claudia
authors.initials: C
authors.lastname: Schmidt
authors.forename: Jill
authors.initials: J
authors.lastname: Gilmour
authors.forename: Tony
authors.initials: T
authors.lastname: Tarragona
authors.forename: Carol
authors.initials: C
authors.lastname: Smith
authors.forename: Burc
authors.initials: B
authors.lastname: Barin
authors.forename: Len
authors.initials: L
authors.lastname: Dally
authors.forename: Bruce
authors.initials: B
authors.lastname: Johnson
authors.forename: Andrew
authors.initials: A
authors.lastname: Muluubya
authors.forename: Leslie
authors.initials: L
authors.lastname: Nielsen
authors.forename: Peter
authors.initials: P
authors.lastname: Hayes
authors.forename: Mark
authors.initials: M
authors.lastname: Boaz
authors.forename: Peter
authors.initials: P
authors.lastname: Hughes
authors.forename: Tomás
authors.initials: T
authors.lastname: Hanke
authors.forename: Andrew
authors.initials: A
authors.lastname: McMichael
authors.forename: Job
authors.initials: J
authors.lastname: Bwayo
authors.forename: Pontiano
authors.initials: P
authors.lastname: Kaleebu
mesh_terms: 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
chemical_list: D016915:AIDS Vaccines; D018984:Epitopes, T-Lymphocyte; D010919:Placebos; D019444:Vaccines, DNA; D054301:gag Gene Products, Human Immunodeficiency Virus; D007371:Interferon-gamma