Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and low-seropositive healthy adults

• Published in: Vaccine Vol. 25; no. 11; pp. 2139 - 2144
• Main Authors: Macaladad, N, Marcano, T, Guzman, M, Moya, J, Jurado, F, Thompson, M, Meechan, C, Li, D, Schlienger, K, Chan, I, Sadoff, J, Schödel, F, Silber, J.L
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.2007; Elsevier; Elsevier Limited
• Subjects: Adult; Age; Aged; Allergy and Immunology; Antibodies, Viral - blood; Applied microbiology; Biological and medical sciences; Clinical trial; Double-Blind Method; Drug therapy; Exanthema; Female; Females; Fundamental and applied biological sciences. Psychology; Herpes Zoster - immunology; Herpes Zoster - prevention & control; Herpes Zoster Vaccine - adverse effects; Herpes Zoster Vaccine - immunology; Herpesvirus 3, Human - immunology; Human viral diseases; Humans; Hypotheses; Infectious diseases; Male; Medical sciences; Microbiology; Middle Aged; Miscellaneous; Placebos; Post-herpetic neuralgia; Vaccines; Vaccines, antisera, therapeutical immunoglobulins and monoclonal antibodies (general aspects); Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Varicella-zoster virus; Viral diseases; Viral diseases with cutaneous or mucosal lesions and viral diseases of the eye; Virology; VZV-seronegative; Zoster; Zoster vaccine; Venezuela; United States > US; Philippines; Costa Rica; Clinical trial; VZV-seronegative; Post-herpetic neuralgia; Varicella-zoster virus; Zoster; Zoster vaccine; Human; Varicella zoster virus; Nervous system diseases; Toxicity; Herpesviridae; Alphaherpesvirinae; Herpes; Vaccine; Infection; Virus; Pain; Immunogenicity; Viral disease; Adult; Neuralgia; Neurological disorder
• ISSN: 0264-410X; 1873-2518
• DOI: 10.1016/j.vaccine.2006.11.011

Abstract Objective To evaluate immunogenicity and tolerability of a live attenuated zoster vaccine in varicella-zoster virus (VZV) seronegative or low-seropositive adults ≥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 (≤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 (∼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) ≤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 ≥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 ≥30 years of age, regardless of initial VZV antibody serostatus.