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.

Potency assay design for adjuvanted recombinant proteins as malaria vaccines.

Many licensed vaccines are composed of live, attenuated or inactivated whole-cell microorganisms, or they comprise purified components from whole-cell extracts or culture supernatants. For some diseases, pathology is fairly well understood, and there may be known correlates of protection that provide obvious parameters for assessment of vaccine potency. However, this is not always the case, and some effective vaccines are routinely used even though the mechanisms or correlates of protection are unknown.

Industrial implementation of in vitro production of monoclonal antibodies.

Monoclonal antibodies are widely used at GlaxoSmithKline Biologicals (GSK Bio) for the quantification and characterization of antigens and for the release of vaccine lots. In 1998, GSK Bio decided to change the production of monoclonal antibodies (MAbs) designed for immunological tools from in vivo to in vitro technology. In 2004, all MAbs used at GSK Bio were produced in vitro.