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Nonclinical toxicology study of recombinant-plasmid DNA anti-rabies vaccines

Kumar, PU and Kumar, BD and Annapurna, VV and Krishna, TP and Kalyanasundaram, S and Suresh, P and Harishankar, N and Jagadeesan, V and Hariharan, S and Naidu, AN and Krishnaswamy, K and Rangarajan, PN and Srinivasan, VA and Reddy, GS and Sesikeran, B (2006) Nonclinical toxicology study of recombinant-plasmid DNA anti-rabies vaccines. In: Vaccine, 24 (15). pp. 2790-2798.

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Official URL: https://doi.org/10.1016/j.vaccine.2006.01.002


The absence of standard guidelines from National and International regulatory agencies for the safety evaluation of biotechnology products challenges the ingenuity of toxicologists. At present, the development of standard pre-clinical toxicology protocols for such products is on an individual case basis. The present investigation is an attempt to evaluate the safety profile of the first indigenously developed DNA based anti-rabies vaccine in India. The test compounds were DNA rabies vaccine DRV (100 μg) and combination rabies vaccine (CRV (100 μg DRV and 1/50 dose of cell culture vaccine)), intended for clinical use by intramuscular route on 1, 7, 14 and 28 day. As per the regular mandatory requirements, the study has been designed to undertake acute (single dose - 10 days), sub-chronic (repeat dose - 28 days) and chronic (intended clinical dose - 120 days) toxicity tests using three dose levels viz. therapeutic, average (2 x therapeutic dose) and highest dose (10 x therapeutic dose) exposure in Swiss Albino mice. The selection of the rodent model viz. Swiss Albino mice is based on affinity and rapid higher antibody response during the efficacy studies. Apart from physical, physiological, clinical, hematological and histopathology profiles of all target organs, the tier-I immunotoxicity parameters have also been monitored. There were no observational adverse effects even at levels of 10x therapeutic dose administration of DRV and CRV. The procedure also emphasizes on the designing of protocols for the products developed by recombinant technique. © 2006 Elsevier Ltd. All rights reserved.

Item Type: Journal Article
Publication: Vaccine
Publisher: Elsevier
Additional Information: The copyright of this article is belongs to the Authors.
Keywords: DNA vaccine; plasmid DNA; rabies vaccine; recombinant vaccine, article; controlled study; dose response; drug safety; female; immunotoxicity; male; mouse; nonhuman; parameter; priority journal; recombinant plasmid; toxicity testing, Acute Toxicity Tests; Animals; Female; Male; Mice; Rabies Vaccines; Toxicity Tests, Chronic; Vaccines, DNA; Vaccines, Synthetic
Department/Centre: Division of Biological Sciences > Biochemistry
Date Deposited: 01 Jun 2022 05:59
Last Modified: 01 Jun 2022 05:59
URI: https://eprints.iisc.ac.in/id/eprint/73003

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