The Israel Institute for Biological Research (IIBR) has obtained regulatory approval to initiate human clinical trials for its Covid-19 vaccine candidate on 1 November.
The Israeli Ministry of Defense said that the Health Ministry and the Helsinki Committee, a panel of physicians and advocates that decides on research approval for human experiments, gave approval for the initiation of trials after rigorous preparations and R&D.
In March, IIBR started animal trials for its single-dose vaccine candidate named BriLife, according to Israeli media NoCamels.
BriLife has vesicular stomatitis virus (VSV), an animal virus that does not cause disease in humans, and where the spike protein was replaced with that of SARS-CoV-2.
The human trials will be conducted over several months in three distinct phases.
During the first phase, the vaccine’s safety will be accessed in the trial on 80 healthy volunteers aged between 18 and 55. Each subject will be given a dose of the BriLife vaccine or placebo.
They will be discharged after a few hours of supervision and monitored for three weeks. The trial will evaluate whether the vaccine induces the production of antibodies against the SARS-CoV-2 virus.
The second phase of the trial, anticipated to start in December, will enrol 960 adults.
On obtaining positive results from the trials, a large-scale third phase of the trial on 30,000 participants is planned to be conducted in April or May next year.
The ministry said that the vaccine candidate showed satisfactory results in animal models.
For the first and second phases of the trials, the IIBR has produced over 25,000 doses of the vaccine.
IIBR Director Shmuel Shapira was quoted by Reuters as saying: “Our final goal is 15 million rations for the residents of the State of Israel and for our close neighbours.”