Evaluation of the Affordable Medicines Facility - Malaria

摘要

Table 1 of the paper compares the demographic characteristics of participants in the dengue vaccine group versus the control group but makes no comparison between the demographics of the immunological subset and the per-protocol set for efficacy (PPSE). We do not claim that the non-random nature of enrolment into the immunological subset is guaranteed free of bias; however, there is no evidence for McKibben's suggestion that the subset could be biased towards the enrolment of younger children. Age was similar between the PPSE and the immunological subset, as assessed by mean, median, SD, and range. Furthermore, the observed immune response was comparable to previously generated immunogenicity data in other phase 1 and 2 studies.23 Meng Ling Moi and colleagues advocate further investigation of in-vitro assays based on the in-vivo targets of dengue. As mentioned in our Discussion, we agree that measurement of dengue virus neutralisation in a system modelled on in-vivo targets deserves further study, and such work is ongoing: