@Dev12 & @Danubio asked my thoughts re yesterdays conferences. I listened to both. My thoughts re the update of COVID p1 trial, for anyone interested. 1. Safety data seems good, which is largely expected, I think. 2. The protocol change (studying 1 dose only, except the cohort 1, n=5) make no or little sense to me. Based on what VXRT submitted for IND, FDA has cleared VXRT to study 1 & 2 doses, like others= MRNA, PFE, AZN, *JNJ, NVAX, INO's p1. *JNJ later pursue a single shot in p3, but in the p1, JNJ studied both 1 & 2 doses. Screen shot taken from JNJ PR jnj.com/johnson-johnson-pos... Perhaps VXRT is certain from hamster data & the difference seen between the n=5 group on Day 29 + ? day after vs. the rest of n=30 on Day 8 [1 dose]. very odd decision, scientifically, imo. 3. Missing neutralized antibody data. I understand VXRT's oral vaccine has a different immunogenicity profile than injectables & thus VXRT [likes to ] emphasize T-cells response (to be continued)
@CCAbbott @Joecryptus , CC - Good point. The hamster developed antibody titers, and this was the most exciting part from the additional Hamster data. I am sure the same is true for Humans too. We just need to give them time to analyse the entire chohort and publish then prelim P1 data officially, which is yet to be published via PR. The would want to throw some crumbs and clues on whats ahead.. I would not be worried at all when all their previous human trials did produce the same this will be the case here too.
@Rohny @Joecryptus >>when [ALL] their previous human trials did produce the same [antibody] this will be the case here too<< Rohny, this is not correct, unfortunately. Per VXRT's p2 flu challenge results, VXRT's group showed *much LESS* antibody response in both Magnitude & Response Rate [% of subjects vaccinated who developed elevated antibodies] 1. Magnitude: 30 days after vaccination, for HAI antibody: 30(VXRT) vs. 273.1 (fluzone) for neutralizing antibody is 58.6 (VXRT) vs. 1838 (fluzone) 2. Response Rate: for HAI antibody: 36% (VXRT) vs. 90% (fluzone) for neutralizing antibody: 57% (VXRT) vs. 99% (fluzone) *ALL comparisons between VXRT & fluzone has a *p=<0.001, meaning: [highly] statistically-significant differences bw the two vaccines re antibody response. screenshot from Table 4 on pg 7 docdroid.net/Uag84nI/lancet...
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