Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults.
Two double-blind randomised controlled studies (phase I and I/II) were performed to assess for the first time the safety and immunogenicity of a recombinant subunit gp350 Epstein-Barr virus (EBV) vaccine in 148 healthy adult volunteers. All candidate vaccine formulations had a good safety profile and were well tolerated, with the incidence of solicited and unsolicited symptoms within a clinically acceptable range. One serious adverse event was reported in the phase I trial which was considered to be of suspected relationship to vaccination. The gp350 vaccine formulations were immunogenic and induced gp350-specific antibody responses (including neutralising antibodies).
Moutschen
Michel
M
Department of Infectious Diseases and General Internal Medicine, CHU Sart-Tilman, University of Liège, Liège, Belgium. michel.moutschen@ulg.ac.be
Léonard
Philippe
P
Sokal
Etienne M
EM
Smets
Françoise
F
Haumont
Michèle
M
Mazzu
Pasqualina
P
Bollen
Alex
A
Denamur
Francoise
F
Peeters
Pascal
P
Dubin
Gary
G
Denis
Martine
M
D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D000956:Antigens, Viral / Q000276:immunology*; D004311:Double-Blind Method; D004797:Enzyme-Linked Immunosorbent Assay; D020031:Epstein-Barr Virus Infections / Q000517:prevention & control*; D005260:Female; D004854:Herpesvirus 4, Human / Q000276:immunology*; D022283:Herpesvirus Vaccines / Q000009:adverse effects* / Q000276:immunology*; D006801:Humans; D008297:Male; D009500:Neutralization Tests; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology; D014614:Vaccines, Synthetic / Q000009:adverse effects / Q000276:immunology; D014763:Viral Matrix Proteins / Q000276:immunology*
D000914:Antibodies, Viral; D000956:Antigens, Viral; C037662:EBV-associated membrane antigen, Epstein-Barr virus; D022283:Herpesvirus Vaccines; D022223:Vaccines, Subunit; D014614:Vaccines, Synthetic; D014763:Viral Matrix Proteins