EV02: a Phase I trial to compare the safety and immunogenicity of HIV DNA-C prime-NYVAC-C boost to NYVAC-C alone.
The aim of this randomised controlled trial was to see if the addition of 4 mg/ml DNA-C priming given by the intramuscular route at weeks 0 and 4 to NYVAC-C at weeks 20 and 24, safely increased the proportion of participants with HIV-specific T-cell responses measured by the interferon (IFN)-gamma ELISpot assay at weeks 26 and/or 28 compared to NYVAC-C alone. Although 2 individuals discontinued after the first DNA-C due to adverse events (1 vaso-vagal; 1 transient, asymptomatic elevation in alanine transaminase), the vaccines were well tolerated. Three others failed to complete the regimen (1 changed her mind; 2 lost to follow-up). Of the 35 that completed the regimen 90% (18/20) in the DNA-C group had ELISpot responses compared to 33% (5/15) that received NYVAC-C alone (p=0.001). Responses were to envelope in the majority (21/23). Of the 9 individuals with responses to envelope and other peptides, 8 were in the DNA-C group. These promising results suggest that DNA-C was an effective priming agent, that merits further investigation.
McCormack
Sheena
S
MRC Clinical Trials Unit, 222 Euston Road, London NW1 2DA, UK. smc@ctu.mrc.ac.uk
Stöhr
Wolfgang
W
Barber
Tristan
T
Bart
Pierre-Alexandre
PA
Harari
Alexandre
A
Moog
Christiane
C
Ciuffreda
Donatella
D
Cellerai
Cristina
C
Cowen
Miranda
M
Gamboni
Romilda
R
Burnet
Séverine
S
Legg
Ken
K
Brodnicki
Elizabeth
E
Wolf
Hans
H
Wagner
Ralf
R
Heeney
Jonathan
J
Frachette
Marie-Joëlle
MJ
Tartaglia
Jim
J
Babiker
Abdel
A
Pantaleo
Giuseppe
G
Weber
Jonathan
J
D016915:AIDS Vaccines / Q000008:administration & dosage / Q000276:immunology / Q000627:therapeutic use*; D000328:Adult; D000956:Antigens, Viral / Q000096:biosynthesis / Q000235:genetics / Q000276:immunology*; D015195:Drug Design; D005260:Female; D015658:HIV Infections / Q000276:immunology / Q000517:prevention & control*; D015497:HIV-1 / Q000145:classification / Q000235:genetics / Q000276:immunology; D006801:Humans; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D008297:Male; D012449:Safety; D014765:Viral Vaccines / Q000008:administration & dosage / Q000737:chemistry* / Q000276:immunology*; D054299:env Gene Products, Human Immunodeficiency Virus / Q000235:genetics
D016915:AIDS Vaccines; D000956:Antigens, Viral; C078787:NYVAC vaccine; D014765:Viral Vaccines; D054299:env Gene Products, Human Immunodeficiency Virus