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Worldwide, the prevalence of noncommunicable chronic diseases is increasing. The use of vaccines to induce autoantibodies that neutralize disease-related proteins offers a means to effectively and affordably treat such diseases. Twenty vaccines designed to induce therapeutic autoantibodies were clinically tested in the past 12 years. Immunodrugs are therapeutic vaccines comprising virus-like particles (VLPs) covalently conjugated with self-antigens that induce neutralizing autoantibody responses. Four such VLP-based vaccines have been clinically tested and one has achieved proof of principle: a reduction of blood pressure in hypertensive patients. To facilitate preliminary clinical testing, novel nonclinical study programs have been developed. Safety study designs have considered the underlying B and T cell immunology and have examined potential toxicities of vaccine components and primary and secondary pharmacodynamic action of the vaccines.

Original publication

DOI

10.1146/annurev-pharmtox-061008-103129

Type

Journal article

Journal

Annu Rev Pharmacol Toxicol

Publication Date

2009

Volume

49

Pages

303 - 326

Keywords

Animals, Chronic Disease, Clinical Trials, Phase I as Topic, Drug Evaluation, Preclinical, Humans, Immunotherapy, Microscopy, Electron, Models, Theoretical, Nanoparticles, Vaccines, Virion