Cambridge, UK - 14 February 2002 - Acambis plc ("Acambis") (LSE: ACM,
NASDAQ: ACAM) announces that it has successfully completed a second Phase II
trial of its ChimeriVax-JE vaccine against Japanese encephalitis ("JE").
The aims of the trial were to compare the safety and immunogenicity of a
range of dose levels of the vaccine and to ascertain the need, or otherwise,
for a second dose to achieve maximum immunity. The randomized, double-blind
placebo-controlled out-patient trial was conducted in 99 healthy adults.
The preliminary findings from the trial are as follows:
* ChimeriVax-JE was well-tolerated at all doses tested
* 98% of subjects developed JE-neutralizing antibodies within one
month of vaccination
* The seroconversion rate was similar across all dose levels. The
lowest dose was approximately 1,000 times lower than the highest dose
used previously
* A single dose of ChimeriVax-JE was as immunogenic as two doses of
vaccine
These results reinforce the belief that ChimeriVax-JE has potential as a
single-dose vaccine for travellers to JE-endemic areas. The trial also
demonstrated that the vaccine is strongly immunogenic, with better than
expected results at even the lowest dose levels.
Based on these encouraging results, Acambis will now undertake the necessary
process development and scale-up activities to manufacture vaccine for
pivotal Phase III trials, which are targeted to begin next year. In
parallel, additional Phase II trials are planned this year, including the
first evaluation of ChimeriVax-JE in children living in JE-endemic areas.
Dr John Brown, Chief Executive Officer of Acambis, said:
"This positive set of results is particularly significant as ChimeriVax-JE
is our lead product developed using our proprietary ChimeriVax technology,
which is also being applied to vaccines against dengue fever and West Nile
encephalitis. The fact that even low doses of ChimeriVax-JE were strongly
immunogenic is very encouraging, and the results reinforce our confidence
that this is an ideal for travellers." |
