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. 2020 Oct 6;27:100517. doi: 10.1016/j.eclinm.2020.100517

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© 2020 The Authors

This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

PMC Copyright notice

Fig. 1 — Clinical study flow diagram and timeline. This phase 1 clinical study was double-blinded and dose-escalated. (A) Each cohort included 6 volunteers vaccinated with escalating doses of rBCG-N-hRSV (Cohort A: 5 × 10³ CFU (blue); Cohort B: 5 × 10⁴ CFU (red); Cohort C: 1 × 10⁵ CFU (green)) and 2 volunteers vaccinated with the standard BCG at full dose (BCG-WT 2 × 10⁵ CFU (purple)). A DSMB evaluated the safety data of each cohort after the first 30 days of follow-up and decided if escalation could continue. (B) A timeline indicating the periods of immunization and end of visits is shown. RSV peaks reported during 2017 and 2018 are also indicated.