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Results of Phase I Study of CETP Vaccine for Low HDL Announced.(Brief Article)
2001 JAN 31 - (NewsRx.com & NewsRx.net) -- Avant Immunotherapeutics (AVAN), Needham, Massachusetts, announced the results of a double-blind placebo controlled, Phase I trial of its CETP vaccine (CETi-1) in 48 healthy adult volunteers.
The objective of the study was to evaluate the safety of CETi-1 in adults. CETi-1 is being developed for the management of patients with low levels of HDL (high-density lipoprotein) cholesterol; HDL at adequate levels is associated with a reduced risk of atherosclerosis and consequently heart disease. The trial was conducted at the Chicago Center for Clinical Research under the supervision of principal investigator Dr. Michael Davidson, a leading authority on cholesterol metabolism.
Announcing the results, Alistair Wheeler, MD, Avant, said, "The objective of this study was to evaluate the safety of a single administration of the CETi-1 vaccine. It is known that vaccines of this type require 'booster' doses to elicit an immune reaction. As a result, we had no expectations of any evidence of an antibody response or of efficacy."
Continuing, Wheeler added, "In these 48 subjects, the vaccine was very well tolerated. The only serious adverse reaction reported during the study [allergic reaction to shower gel] was not related to study medication. There were no differences in the safety profiles of placebo groups and active vaccine groups. In addition there was limited evidence of an immune response in one subject treated with the highest dose."
In concluding, Wheeler commented, "The study has met its ...
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Source: HighBeam Research, Results of Phase I Study of CETP Vaccine for Low HDL Announced.(Brief...