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. 2022 Mar 25;13:1603. doi: 10.1038/s41467-022-29226-3

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© The Author(s) 2022

Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit http://creativecommons.org/licenses/by/4.0/.

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Fig. 1 — The study flow diagram describes the number of individuals in the screening, immunization, and CHMI steps. From 121 volunteers who initially accepted screening (38 naive, 83 semi-immune), 86 were excluded or declined participation and 35 were enrolled. Seventeen were naive and were allocated to Phase IIa study [12 Experimental (Exp) + 5 Control (Ctrl)], and 18 semi-immune to the Phase IIb study (13 Exp + 5 Ctrl). All 35 volunteers (age range 19–44 years) were immunized with PvCS LSP or placebo formulated in Montanide ISA-51. Two volunteers withdrew after the first immunization, and one more (semi-immune) was dropped out because of diabetes mellitus diagnosis.