OBJECTIVE: To 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 DESIGN: Double-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 OBJECTIVE: summarize the VZV antibody response postvaccination. RESULTS:Twenty-one subjects (age 27 to 69 years; median 34) enrolled (1148 prescreened); 18 (including 4 seronegative subjects) receivedvaccine 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. CONCLUSIONS: The zoster vaccine appears to be immunogenic and generally well tolerated in healthy adults > or = 30 years of age, regardless of initial VZV antibody serostatus.
RCT Entities:
OBJECTIVE: To 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 DESIGN: Double-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 OBJECTIVE: summarize the VZV antibody response postvaccination. RESULTS: Twenty-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. CONCLUSIONS: The zoster vaccine appears to be immunogenic and generally well tolerated in healthy adults > or = 30 years of age, regardless of initial VZV antibody serostatus.
Authors: English D Willis; Meredith Woodward; Elizabeth Brown; Zoran Popmihajlov; Patricia Saddier; Paula W Annunziato; Neal A Halsey; Anne A Gershon Journal: Vaccine Date: 2017-11-22 Impact factor: 3.641
Authors: Alexander V Murray; Keith S Reisinger; Boris Kerzner; Jon E Stek; Timothy A Sausser; Jin Xu; William W Wang; Ivan S F Chan; Paula W Annunziato; Janie Parrino Journal: Hum Vaccin Date: 2011-11-01
Authors: Santosh C Sutradhar; William W B Wang; Katia Schlienger; Jon E Stek; Jin Xu; Ivan S F Chan; Jeffrey L Silber Journal: Clin Vaccine Immunol Date: 2009-03-04