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Volume 169, Issue 1, Pages 113-120 (July 2003)


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The safety and immunogenicity of a CETP vaccine in healthy adults

Michael H. DavidsonaCorresponding Author Informationemail address, Kevin Makia, Denise Umporowicza, Alistair Wheelerb, Charles Rittershausb, Una Ryanb

Received 20 September 2002; received in revised form 20 February 2003; accepted 7 March 2003.

Abstract 

A cholesterol ester transfer protein (CETP) vaccine (CETi-1) that induces auto-antibodies that specifically bind and inhibit activity of endogenous CETP has been demonstrated in rabbits to significantly increase HDL-C and reduce the development of atherosclerosis. In a Phase I human trial with CETi-1, one patient at the highest dose (250 mg) out of a total of 36 patients who received a single injection developed anti-CETP antibodies. In an extension study of 23 patients, 53% (8/15) who received a second injection of the active vaccine developed anti-CETP antibodies compared with 0% (0/8) in the placebo group. The vaccine was well tolerated and no significant laboratory abnormalities occurred. CETi-1 is a feasible therapy in humans to induce CETP auto-antibodies. Future research will determine if repeat inoculations will induce a sufficient anti-CETP antibody response to inhibit CETP and increase HDL levels.

a Rush-Presbyterian-St. Luke's Medical Center, Chicago Center for Clinical Research, 515 North State Street, Suite 2700, Chicago, IL 60610, USA

b AVANT Immunotherapeutics, Inc., Needham, MA, USA

Corresponding Author InformationCorresponding author. Tel.: +1-312-563-2011; fax: +1-312-563-4417

PII: S0021-9150(03)00137-0

doi:10.1016/S0021-9150(03)00137-0


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