Definitive Toxicology and Biodistribution Study of a Polyvalent Dna Prime/Protein Boost Human Immunodeficiency Virus Type 1 (Hiv-1) Vaccine in Rabbits.
From: Department of Cell Biology, Advanced BioScience Laboratories, 5510 Nicholson Lane, Kensington, MD 20895, USA. Ranajit.Pal@ablinc.com
Vaccine
- Publish Date: Feb 2006
- ISSN: 0264-410X
- Volume: 24
- Issue: 8
- Pages: 1225-34
- Medium: Print
- Language: English
- Citation (JAMA): Pal Ranajit, Yu Qiao, Wang Shixia, et al. Definitive Toxicology and Biodistribution Study of a Polyvalent Dna Prime/Protein Boost Human Immunodeficiency Virus Type 1 (Hiv-1) Vaccine in Rabbits.. Vaccine Feb 2006;24:1225-34
Abstract
A toxicity and immunogenicity study, evaluating the safety of a polyvalent DNA prime/protein boost HIV-1 vaccine (DP6-001), was examined in rabbits. Animals were primed with a cocktail of six different DNA plasmids expressing five HIV-1 env genes and one gag gene followed by boosting with five gp120 proteins homologous to the DNA vaccines. The vaccine was shown to be immunogenic as evident from the induction of high-titered anti-Env and anti-Gag antibodies. There was an absence of detectable adverse effects on key toxicology parameters. Although plasmids persisted in the injection sites following single administration for 64 days, no evidence of integration into the host genomic DNA was observed. These studies demonstrate that a novel polyvalent DNA prime/protein boost vaccine lacks signs of toxicity and DNA integration in a rabbit model, and immunogenicity and toxicology data support clinical testing of the vaccine in humans.
Mesh Headings (Keywords): AIDS Vaccines, Animals, HIV Envelope Protein gp120, HIV-1, Immunization Schedule, Plasmids, Rabbits, Tissue Distribution, Vaccines, DNA
Check for Full Text / PubMed Unique Identifier (PMID): 16219399
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