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The Lancet paper partly discusses the problem. Part of teh manufacturing process is determining the dose concentration. For the Phase I trial they manufactured the vaccine themselves and the concentration was determined by spectrophotometry. They then used a contractor to manufacture the vaccine and it found that spectrophotometry and qPCR gave different results for the concentration. They went with spectrophotometry. They tested subjects for immune response and found that it was poorer than in the Phase 1, and concluded that there was a problem with teh spectrophotometry. So they switched to qPCR to measure concentration.

I agree with Steven Senn's comment that the difference is likely to be one of those spurious results that happen at times in clinical trials.


Ken: I will be reviewing the Lancet paper soon. My brief read of it is the explanation is not detailed enough. If what you said was true, did they conduct an unblinded analysis while the trial was ongoing? Further, the explanation does not address my question. How did they go backwards and identify which specific subjects got the lower dose? I'll say more after I take in the whole paper.

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