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Ann: Admedus announces further data from HSV-2 Trial, page-129

  1. 15 Posts.
    The trial data appears to be as expected. T-cell responses being absent in some people is not particularly uncommon following a vaccine and should be expected in vaccine trials. It would have been nice if they gave us some indication of the CD8+ T-cell recruitment vs CD4+ T-cells , this would provide a much better indication of the immune responses generated. However it is not uncommon to simply evaluate the T-cell response as IFN-g producing and hence does not speculate on quality or functionality of response. The lack of significant antibody responses by a third party doesn't state if there were absent completely or merely below the determined significance level. The report appears to imply they were completely absent, if they were conducted in a commercial laboratory they generally require higher levels to state they are significant compared to an academic laboratory which is happy to state they have some but are not of a significant level. In addition a academic laboratory is not set up for high through put and more care is generally taken when completing this type of analysis. In addition, antibody assays (ELISA) are notoriously inconsistent and therefore significance is not easily obtained in a small sample size (eg. 20 people in this study is small) and would be better analysed in a large trial (eg phase 2). In summary the results were as expected and should not deter any interest in the vaccine. If they were trying to encourage support from the scientific community a little more scientific detail could have been divulged for better evaluation of the vaccines future potential. The minor side efforts (essentially a skin irritation/rash) post vaccination is common following a dermal vaccination in small animal studies and should have been expected in a clinical setting.
 
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