Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults.
(2007) Vaccine — Vol. 25, n° 24, p. 4697-4705 (2007)
Files
pdfdocument.pdf
Restricted Access - Adobe PDF
- 148.28 KB
Details
- Authors
- Abstract
- 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).
- Affiliations
Citations
Moutschen, M., Léonard, P., Sokal, E., Smets, F., Haumont, M., Mazzu, P., Bollen, A., Denamur, F., Peeters, P., Dubin, G., & Denis, M. (2007). Phase I/II studies to evaluate safety and immunogenicity of a recombinant gp350 Epstein-Barr virus vaccine in healthy adults. Vaccine, 25(24), 4697-4705. https://doi.org/10.1016/j.vaccine.2007.04.008 (Original work published 2007)