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Phase 1 trial finds a CETP vaccine induces anti-CETP antibodies and is well tolerated in healthy adults (Atherosclerosis 2003)

Original title: The safety and immunogenicity of a CETP vaccine in healthy adults

Atherosclerosis · · 6

Davidson MH, Maki K, Umporowicz D, Wheeler A, Rittershaus C, Ryan U

The CETP vaccine CETi-1, which had been shown in rabbits to induce auto-antibodies that bind and inhibit endogenous CETP, raise HDL cholesterol and reduce atherosclerosis, was tested for safety and immunogenicity in a phase 1 human trial. Among 36 patients who received a single injection, one at the highest dose (250 mg) developed anti-CETP antibodies. In an extension study, 53% (8 of 15) of patients who received a second injection of active vaccine developed anti-CETP antibodies compared with 0% (0 of 8) on placebo. The vaccine was well tolerated with no significant laboratory abnormalities, demonstrating CETi-1 is a feasible approach to inducing anti-CETP antibodies in humans, with future work needed to determine whether repeat dosing can achieve a sufficient antibody response to raise HDL levels.

Read the paper (DOI)PubMed

Original 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.

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Summary written by cetpinhibition.org from the published abstract; figures as published. Page updated 19 August 2026. Methods.