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Report Summary

A 12-week Toxicity Study of DNA Vaccine (pTVG-HP) Encoding Human Prostatic Acid Phosphatase (PAP) Administered Intradermally to Male Lewis Rats


Study Summary

Overall Study Design 
Study Objectives 
To determine the safety of a DNA vaccine pTVG-HP encoding human prostatic acid phosphatase PAP when administered 
intradermally to male Lewis rats at two-week intervals over a 12-week period 
To determine the persistence of the pTVG-HP DNA plasmid at the site of immunization and at distant sites when 
administered intradermally to male Lewis rats 
To determine the immunological efficacy of a DNA vaccine pTVG-HP encoding human PAP when administered 
intradermally to male Lewis rats at two-week intervals over a 12-week period 
Rationale 
Studies in laboratory animals provide the best means of assessing the immunological efficacy and toxicity of the DNA 
vaccine intended for human use This study was necessitated by the absence of appropriate non-animal alternatives 
Unfortunately there is no way of modeling the effectiveness of vaccines in a computer simulation or in vitro system A 
preclinical model is necessary to assess the immunological efficacy of the vaccine through establishing immunological 
markers and endpoints The rat serves as an ideal preclinical model because there is also a prostate tissue-specific rat 
homologue of the prostatic acid phosphatase protein that is highly homologous 87 identical to the human gene product 
The information obtained from this study did not unnecessarily duplicate the results of previous studies and could not be 
obtained by other means This study is in support of a pilot clinical trial using the same DNA vaccine in patients with prostate 
cancer 
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    NGVB Manager
    317-274-4519
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