Evaluation of the potency and safety of inactivated Japanese encephalitis vaccine in US inhabitants.

In 1981 and 1982, two US citizens died from Japanese encephalitis (JE) acquired in China. In 1983, the Centers for Disease Control initiated an evaluation of a purified, inactivated, mouse-brain-derived JE vaccine produced and used in Japan since 1966. Two doses of this vaccine given 1-2 weeks apart evoked neutralizing antibody titers greater than or equal to 8 in only 77% of recipients. After three JE vaccine doses administered 1-2 weeks apart, 99% developed titers greater than or equal to 8. When a third dose was given to 29 participants 6-12 months after the primary series, all developed titers greater than or equal to 16. Reported adverse reactions included injection site tenderness (18%), erythema (6%), or swelling (3%); headache (9%); and dizziness, fatigue, sleepiness, nausea, chills, fever, or lower back pain (less than or equal to 5%). On the basis of this study, three doses of BIKEN JE vaccine are recommended for US citizens who may be at risk of exposure to JE virus.