Se. Frey et al., Effects of antigen dose and immunization regimens on antibody responses toa cytomegalovirus glycoprotein B subunit vaccine, J INFEC DIS, 180(5), 1999, pp. 1700-1703
The purpose of this phase I study was to evaluate the safety and immunogeni
city of 2 doses of cytomegalovirus glycoprotein B (CMV gB)/MF59 vaccine at
3 different immunization schedules. Ninety-five volunteers were randomized
to 6 groups. Antibodies to gB represent the majority of the CMV-specific ne
utralizing response. Three groups received 5 mu g of gB antigen combined wi
th MF59 (a proprietary adjuvant) and 3 groups received a 30-mu g dose at 0,
1, and 2 months; 0, 1, and 4 months; or 0, 1, and 6 months,The vaccine was
well tolerated, and there was no significant difference in antibody produc
tion between the 2 doses, The vaccine induced highest antibody titers when
given at 0, 1, and 6 months. A low dose of CMV gB/ MF59 may be the preferre
d dose for future studies.