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Article History

Received: 21 March 2021

Accepted: 29 June 2021

First Online: 9 July 2021

Declarations

:

: The IMRAS study was conducted at the Naval Medical Research Center (NMRC) Clinical Trials Center from 2014 to 2016; the CHMIs were conducted at the Walter Reed Army Institute of Research (WRAIR) secure insectary. The study protocol was reviewed and approved by the NMRC Institutional Review Board in compliance with all federal regulations governing the protection ofhuman subjects. WRAIR holds a Federalwide Assurance from the Office of Human Research Protections (OHRP) under the Department of Health and Human Services as does NMRC. NMRC also holds a Department of Defense/Department of the Navy Federal- wide Assurance for human subject protections. All key personnel were certified as having completed mandatory human subjects’ protection curricula and training under the direction of the WRAIR Institutional Review Board or the NMRC Office of Research Administration (ORA) and Human Subjects Protections Branch (HSPB). All potential study subjects provided written, informed consent before screening and enrollment and had to pass an assessment of understanding. This study was conducted according to the Declaration of Helsinki as well as principles of Good Clinical Practices under the United States Food and Drug Administration Investigational New Drug (IND) application BB-15767. This trial was performed under an IND allowance by the Food and Drug Administration (FDA) and was registered on Clinical-Trials.gov (NCT01994525).The BSPZV1 trial was conducted in Bagamoyo, Tanzania between April 2014 and August 2015 in accordance with Good Clinical Practices. All study participants had to complete a 20-question assessment of trial understanding with a 100% correct response rate on the first or second attempt to be eligible. The protocol was approved by institutional review boards (IRBs) of the Ifakara Health Institute (IHI) (Ref. No. IHI/IRB/No:02-2014), the National Institute for Medical Research Tanzania (NIMR/HQ/R.8a/ Vol.IX/1691), the Ethikkommission Nordwest-und Zentral- schweiz, Basel, Switzerland (Reference number 261/13), and by the Tanzania Food and Drug Authority (Ref. No. TFDA 13/CTR/ 0003); registered at Clinical Trials.gov (NCT02132299); and conducted under U.S. FDA IND application.

: All authors have seen and approved the content of this manuscript.

: The authors declare that no competing interests exist.