Re: Farmas USA
NVAX Discusión sobre la serología en el grupo de FB: The PCA held up, the question is : Is the PCA assay as valid at predicting protection as (e.g.) I had bet on? Next stop then is the micro neutralizing assay. Looking back at e.g. maternal P2 they see the immunogenicty as measured by MNs is better in those with a lower baseline (folks with presumably previous exposure). In maternal P2 MN fold induction was ~2.6x to as much as 6x (adjuvanted for 6x) across various grouped baselines (confusing to read) with ~2.6x MN for the study. The P3 elderly is showing something like just under 2x ... hmmm. I would have to dig and speculate for a while to try to cook up a solid opinon on what may be reasonably likely to constitute a decent MN. In the rats is was 6x - I spent the morning looking back at old presentations. It appears that the elderly MN has been consistent under 2X. The interesting thing is that in adjuvanted arms, it was higher. I am not a scientist, so I don't know what all that means. But, I could not see any difference in the elderly from trial to trial based on the various presentations and posters. Of course, your previous post made me search MN and I now understand what 2 Fold and 4 Fold means, but I don't know how in the RSV-F vaccine what a good or bad number means. - Yea, in some ways one could say thast nobody knows, and the P3 was going to provide that information (MN vs protection), and it has, and its not good ... unless one attaches to this low attack rate stuff. So from slide "“there is no clearly defined protective titer “ slide 5 http://novavax.com/download/files/presentations/Glenn_RSV_F_Recombinant_Nanoparticle_Vaccine_JH.pdf# - those PCA levels in that poster, were, I thought, protective based on Synagis. (imagen adjunta).
