EV01: a phase I trial in healthy HIV negative volunteers to evaluate a clade C HIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium.
NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pol, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone.
Bart
Pierre-Alexandre
PA
Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland.
Goodall
Ruth
R
Barber
Tristan
T
Harari
Alexandre
A
Guimaraes-Walker
Ana
A
Khonkarly
Mona
M
Sheppard
Neil C
NC
Bangala
Yolanda
Y
Frachette
Marie-Joelle
MJ
Wagner
Ralf
R
Liljeström
Peter
P
Kraehenbuhl
Jean-Pierre
JP
Girard
Marc
M
Goudsmit
Jaap
J
Esteban
Mariano
M
Heeney
Jonathan
J
Sattentau
Quentin
Q
McCormack
Sheena
S
Babiker
Abdel
A
Pantaleo
Giuseppe
G
Weber
Jonathan
J
D016915:AIDS Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology*; D000328:Adult; D005260:Female; D015658:HIV Infections / Q000517:prevention & control; D015497:HIV-1 / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010455:Peptides / Q000737:chemistry; D014765:Viral Vaccines / Q000008:administration & dosage* / Q000737:chemistry / Q000276:immunology* / Q000627:therapeutic use
D016915:AIDS Vaccines; C078787:NYVAC vaccine; D010455:Peptides; D014765:Viral Vaccines