A subunit cytomegalovirus vaccine based on recombinant envelope glycoprotein B and a new adjuvant

A phase I randomized, double-blind, placebo-controlled trial was done with a cytomegalovirus (CMV) vaccine based on the envelope glycoprotein, gB, com bined with a novel adjuvant, MF59. Participants received CMV gB vaccine wit h MF59 or CMV gB with alum or placebo at 0, 1, and 6 months. A fourth vacci ne was given at 12 months to a subgroup. Levels of neutralizing antibody an d antibody to gB 2 weeks after the third dose of vaccine exceeded those in seropositive control subjects. the formulation with MF59 was more immunogen ic than that with alum. The optimal dose of gB appeared to be between 5 and 30 mu g. The fourth dose produced a prompt rise in antibody level. There w ere no serious adverse events associated with vaccine. Local and systemic r eactions were generally mild and, except for pain at the injection site, oc curred with similar frequency in recipients of placebo and CMV vaccine.