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


METHODS
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.


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.
Macaladad
N
N
De la Salle University Medical Center, Cavite, Philippines.
Marcano
T
T
Guzman
M
M
Moya
J
J
Jurado
F
F
Thompson
M
M
Meechan
C
C
Li
D
D
Schlienger
K
K
Chan
I
I
Sadoff
J
J
Schödel
F
F
Silber
J L
JL
D000328:Adult; D000368:Aged; D000914:Antibodies, Viral / Q000097:blood*; D004311:Double-Blind Method; D005076:Exanthema; D005260:Female; D006562:Herpes Zoster / Q000276:immunology* / Q000517:prevention & control*; D053061:Herpes Zoster Vaccine / Q000009:adverse effects* / Q000276:immunology*; D014645:Herpesvirus 3, Human / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D010919:Placebos; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000276:immunology
D000914:Antibodies, Viral; D053061:Herpes Zoster Vaccine; D010919:Placebos; D014613:Vaccines, Attenuated