Recombinant gp350 vaccine for infectious mononucleosis: a phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of an Epstein-Barr virus vaccine in healthy young adults.
BACKGROUND
To date, there is no commercially available vaccine to prevent infectious mononucleosis, a disease frequently induced by Epstein-Barr virus (EBV) infection in adolescents or adults devoid of preexisting immunity to the virus.


METHODS
A total of 181 EBV-seronegative, healthy, young adult volunteers were randomized in a double-blind fashion to receive either placebo or a recombinant EBV subunit glycoprotein 350 (gp350)/aluminum hydroxide and 3-O-desacyl-4'-monophosphoryl lipid A (AS04) candidate vaccine in a 3-dose regimen.


RESULTS
The vaccine had demonstrable efficacy (mean efficacy rate, 78.0% [95% confidence interval {CI}, 1.0%-96.0%]) in preventing the development of infectious mononucleosis induced by EBV infection, but it had no efficacy in preventing asymptomatic EBV infection. One month after receipt of the final dose of gp350 vaccine, 98.7% of subjects showed seroconversion to anti-gp350 antibodies (95% CI, 85.5%-97.9%), and they remained anti-gp350 antibody positive for >18 months. Furthermore, there were no concerns regarding the safety or reactogenicity of the gp350/AS04 vaccine.


CONCLUSIONS
These data support the clinical feasibility of using an EBV vaccine to prevent infectious mononucleosis.


BACKGROUND
ClinicalTrials.gov identifier: NCT00430534.
Sokal
Etienne M
EM
Université Catholique de Louvain, Cliniques Universitaires St-Luc, Avenue Hippocrate 10/1301, 1200 Brussels, Belgium. sokal@pedi.ucl.ac.be
Hoppenbrouwers
Karel
K
Vandermeulen
Corinne
C
Moutschen
Michel
M
Léonard
Philippe
P
Moreels
Andre
A
Haumont
Michèle
M
Bollen
Alex
A
Smets
Françoise
F
Denis
Martine
M
D000293:Adolescent; D000328:Adult; D000818:Animals; D036022:Capsid Proteins / Q000276:immunology*; D006224:Cricetinae; D003412:Cricetulus; D004311:Double-Blind Method; D005260:Female; D004854:Herpesvirus 4, Human / Q000235:genetics / Q000276:immunology*; D022283:Herpesvirus Vaccines / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*; D006801:Humans; D007115:Immunization Schedule; D007244:Infectious Mononucleosis / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D008297:Male; D019444:Vaccines, DNA / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use*; D022223:Vaccines, Subunit / Q000235:genetics / Q000276:immunology / Q000627:therapeutic use; D014763:Viral Matrix Proteins / Q000235:genetics / Q000276:immunology*
D036022:Capsid Proteins; C037662:EBV-associated membrane antigen, Epstein-Barr virus; D022283:Herpesvirus Vaccines; D019444:Vaccines, DNA; D022223:Vaccines, Subunit; D014763:Viral Matrix Proteins