Ethics statement
5004520186EC0000, ICH
DISEASES
This study was conducted according to the principles of the current revision of the Declaration of Helsinki 2013 and in full conformity with relevant country regulations and with the ICH guidelines for GCP ((CPMP/ICH/135/95) July 1996 (and its Revision 2, dated 9 November 2016)). Prior to enrolment, the protocol and the informed consent forms were approved by the National Ethical Committee (Comité d’Éthique pour la Recherche en Santé: N°2017/000098/MS/MERSI/CERS) and the National Regulatory Board (Ministry of Health: N°5004520186EC0000) in Burkina Faso. Ethical reviews were also conducted by the London School of Hygiene and Tropical Medicine Research Ethics Committee (United Kingdom; Ref: 12348 – 2) and the Research Institute for Microbial Diseases Ethics Committee (Japan; Ref: 28-12-3). Importation permit (N°201702432/MS/SG/DGPML/DRLP/SHPS/SBA) for the Investigational Products (BK-SE36 and CpG) was obtained from Agence Nationale de Régulation Pharmaceutique (ARPN), Burkina Faso.