[Study on safety and effect of purified inactivited Japanese encephalitis vaccine (primary hamster kidney cell, PHK)].
OBJECTIVE
In order to observe the safety and neutralizing antibody response to purified inactivated Japanese encephalitis vaccine (primary hamster kidney cell, PHK).


METHODS
Phase I, II, III field trials were performed and 943 healthy volunteers aged from 6 months to 10 years were administrated the JEV-I (PHK) vaccine at day 0 and day 7 respectively.


RESULTS
The vaccine did not cause any severe systemic and local adverse reactions. In phase I, 40 healthy volunteers were inoculated and the total reaction rate was 2.5%. In phase II and III, 903 healthy volunteers were inoculated JEV-I (PHK) and 101 healthy volunteers were inoculated with the Vero cell-derived JEV vaccine, the total adverse reaction rates were 6.2% and 14.2% respectively. The positive sero conversion rates of neutralizing antibody to the test and the control vaccine in antibody negative group were 96.9% (Geometric Mean Titers, GMT1:32.8) and 84.0% (GMT1:43.9) respectively and in antibody positive group were 93.1% (GMT1:167.2) and 100% (GMT1:181.0) respectively.


CONCLUSIONS
The JEV-I (PHK) vaccine is safe and effective. Trial Registration National Food drugs surveillance administrative bureau, "Medicine Clinical Experiment Written Directive from a Superior" number: 2003L00429.
Li
Wei
W
Lanzhou Institute of Biological Products, Lanzhou 730046, Gansu, China.
Jia
Li-Li
LL
Zou
Yong
Y
D000293:Adolescent; D000328:Adult; D000818:Animals; D057134:Antibodies, Neutralizing; D002460:Cell Line; D002648:Child; D002675:Child, Preschool; D006224:Cricetinae; D004334:Drug Administration Schedule; D064420:Drug-Related Side Effects and Adverse Reactions; D004672:Encephalitis, Japanese / Q000276:immunology / Q000517:prevention & control*; D005260:Female; D006801:Humans; D022321:Japanese Encephalitis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D008297:Male; D008875:Middle Aged; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D057134:Antibodies, Neutralizing; D022321:Japanese Encephalitis Vaccines; D015164:Vaccines, Inactivated