In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in 1040 volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart.

Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) will begin, during which larger cohorts as well as elderly age subjects will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low dose (prime-boost) or saline, 28 days apart.

Phase I of the first clinical trial with Brilife, the COVID-19 vaccine developed by the Israel Institute for Biological Research, was completed at Hadassah Hospital Ein Kerem on November 26, when the 40th participant received the final dose.

Participants ranged in age from 18 through 55 and did not have any pre-existing illnesses.

The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.

Phase II includes larger cohorts as well as elderly age groups. Subjects will be randomly allocated to the study groups in both phases.