Defraites RF, Gambel JM, Hoke CH Jr, Sanchez JL, Withers BG, Karabatsos
N, Shope RE, Tirrell S, Yoshida I, Takagi M, Meschievitz CK, Tsai TF
Division of Preventive Medicine, Walter Reed Army Institute of Research,
Washington, District of Columbia 20307-5100, USA.
Am J Trop Med Hyg 1999 Aug;61(2):288-93
The safety and immunogenicity of Japanese encephalitis (JE) vaccine
(Nakayama strain, monovalent / BIKEN) was studied in 538 U.S. soldiers
in 1990. Three doses of vaccine from three consecutively manufactured
lots were given on days 0, 7, and either 14 or 30. Serum for antibody
determination was drawn at months 0, 2, and 6. Japanese encephalitis
plaque reduction neutralization tests were performed by three
laboratories on each specimen. Five hundred twenty-eight (98%)
participants completed the immunization series. All recipients without
antibody before immunization developed neutralizing antibody against JE
virus. There were no differences in geometric mean titer among the three
test lots at months 2 and 6. Soldiers who received the third dose on day
30 had higher titers at both time points. Antibody to yellow fever had
no significant effect on immune response to vaccine. Conclusions drawn
from analysis of serologic data from the three labs were nearly
identical. Symptoms were generally limited to mild local effects and
were reduced in frequency with each subsequent does in the series (21%
to 11%; P < 0.0001). Generalized symptoms were rare (e.g., fever = 5%)
with no reported cases of anaphylaxis.