The safety endpoint was met in the treatment group. With the exception of fever, rash and eye pain, the overall safety profile of the vaccine was similar to that of the placebo and the unadjuvanted vaccine. Geometric mean titers (GMTs) of VZV-specific antibodies increased significantly in the vaccine group at 3 months post-vaccination (GMT 788.5 for the vaccine group, compared with 197.6 for the placebo group, for pre-vaccination levels), compared with the pre-vaccination level. The VZV-specific IgG antibody levels remained significantly higher than pre-vaccination levels for at least 4 years in patients receiving the vaccine. The antibody levels in the placebo group had decreased to the pre-vaccination level after 4 years. No serious adverse events occurred. There were no vaccine-related serious adverse events. The most common vaccine-related adverse events were injection site reactions, the majority of which were mild and transient, and fever, which was mild in all the patients. There were no cases of neurologic complications. The most common adverse events related to the injection, the most common being pain. The most common systemic reactions in the safety study were headache, muscle ache, cough, runny nose, and myalgia. There were no significant differences between the two groups in the systemic reactions that occurred, and all resolved. No changes in the physical or neurological examination or in standard laboratory tests (including hematology, chemistry, and urinalysis) were found, and no deaths occurred. The vaccine had no clinically significant effects on the numbers of leukocytes and lymphocytes.
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