title: Lessons from IAVI-006, a phase I clinical trial to evaluate the safety and immunogenicity of the pTHr.HIVA DNA and MVA.HIVA vaccines in a prime-boost strategy to induce HIV-1 specific T-cell responses in healthy volunteers.
abstract: IAVI-006 was the first large randomised, double-blinded, placebo-controlled Phase I clinical trial to systematically investigate the prime-boost strategy for induction of HIV-1 specific CD8+ cytotoxic T-lymphocytes (CTL) in a factorial trial design using (i) priming with 0.5 mg or 2 mg of pTHr.HIVA DNA vaccine, followed by (ii) two booster vaccinations with 5 x 10(7) MVA.HIVA at weeks 8 and 12 (early boost) or weeks 20 and 24 (late boost). This study set the basis for later clinical trials and demonstrated the safety of these candidate HIV vaccines. The safety and immunogenicity results are presented and the lessons derived from this clinical trial are discussed.
authors.affiliation: Medical Research Council, Human Immunology Unit, Weatherall Institute of Molecular Medicine, John Radcliffe Hospital, Oxford OX3 9DS, UK. ana.guimaraes-walker@imm.ox.ac.uk
authors.forename: A
authors.initials: A
authors.lastname: Guimarães-Walker
authors.forename: N
authors.initials: N
authors.lastname: Mackie
authors.forename: S
authors.initials: S
authors.lastname: McCormack
authors.forename: T
authors.initials: T
authors.lastname: Hanke
authors.forename: C
authors.initials: C
authors.lastname: Schmidt
authors.forename: J
authors.initials: J
authors.lastname: Gilmour
authors.forename: B
authors.initials: B
authors.lastname: Barin
authors.forename: A
authors.initials: A
authors.lastname: McMichael
authors.forename: J
authors.initials: J
authors.lastname: Weber
authors.forename: K
authors.initials: K
authors.lastname: Legg
authors.forename: A
authors.initials: A
authors.lastname: Babiker
authors.forename: P
authors.initials: P
authors.lastname: Hayes
authors.forename: F
authors.initials: F
authors.lastname: Gotch
authors.forename: C
authors.initials: C
authors.lastname: Smith
authors.forename: L
authors.initials: L
authors.lastname: Dally
authors.forename: L
authors.initials: L
authors.lastname: Dorrell
authors.forename: I
authors.initials: I
authors.lastname: Cebere
authors.forename: R
authors.initials: R
authors.lastname: Kay
authors.forename: N
authors.initials: N
authors.lastname: Winstone
authors.forename: S
authors.initials: S
authors.lastname: Moore
authors.forename: N
authors.initials: N
authors.lastname: Goonetilleke
authors.forename: P
authors.initials: P
authors.lastname: Fast
mesh_terms: D016915:AIDS Vaccines / Q000009:adverse effects / Q000276:immunology*; D000293:Adolescent; D000328:Adult; D018414:CD8-Positive T-Lymphocytes / Q000276:immunology*; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000517:prevention & control*; D015497:HIV-1 / Q000276:immunology*; D006801:Humans; D007117:Immunization, Secondary; D008297:Male; D008875:Middle Aged; D019444:Vaccines, DNA / Q000009:adverse effects / Q000276:immunology*; D055815:Young Adult
chemical_list: D016915:AIDS Vaccines; C505104:MVA-HIVA vaccine; D019444:Vaccines, DNA; C509463:pTHr.HIVA