• N Macaladad, T Marcano, M Guzman, J Moya, F Jurado, M Thompson, C Meechan, D Li, K Schlienger, I Chan, J Sadoff, F Schödel, and J L Silber.
• De la Salle University Medical Center, Cavite, Philippines.
• Vaccine. 2007 Mar 1; 25 (11): 2139-44.

ObjectiveTo evaluate immunogenicity and tolerability of a live attenuated zoster vaccine in varicella-zoster virus (VZV) seronegative or low-seropositive adults > or = 30 years of age.Study DesignDouble-blind, placebo-controlled, randomized, multicenter study. Subjects were enrolled in two stages by prescreened serostatus. Subjects with a low VZV antibody titer (< or = 5 gpELISA units/mL) were enrolled in Stage 1. Subjects with undetecable VZV antibodies and no safety issues identified during Stage 1 were enrolled in Stage 2. All enrolled subjects were randomized 4:1 to receive one dose (approximately 50,000 PFU) of zoster vaccine or placebo and were followed for safety for 42 days postvaccination. Primary objectives/hypotheses: (1) no vaccine-related serious adverse experiences (AE); (2) < or = 1 laboratory-confirmed varicella-like rash with > 50 lesions within 42 days postvaccination.Secondary Objectivesummarize the VZV antibody response postvaccination.ResultsTwenty-one subjects (age 27 to 69 years; median 34) enrolled (1148 prescreened); 18 (including 4 seronegative subjects) received vaccine and 3 (including 1 seronegative subject) received placebo. Twenty subjects completed the study; one subject withdrew for reasons unrelated to safety. No serious vaccine-related AE or laboratory-confirmed varicella-like rashes with > 50 lesions were reported. In the zoster vaccine group, all 4 of the initially seronegative subjects (age 32 to 36 years; median 33.5) seroconverted and 6 of the 13 (46.2%) initially seropositive subjects had a > or = 4-fold rise in VZV-specific antibody titer at 6 weeks postvaccination.ConclusionsThe zoster vaccine appears to be immunogenic and generally well tolerated in healthy adults > or = 30 years of age, regardless of initial VZV antibody serostatus.

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