Phase I of human trials to test Brilife, a vaccine developed by the Israel Institute for Biological Research, is scheduled to commence on November 1, at Sheba Medical Center and Hadassah University Medical Center. The full trials are expected to last several months.
Next week, the Israel Institute for Biological Research (IIBR) plans to begin human trials of its coronavirus vaccine, named Brilife. The vaccine has already been granted all necessary approvals from the Health Ministry and the Helsinki Committee for medical experimentation on humans.
“This is a day of hope for the citizens of Israel,” Defense Minister Benny Gantz said. “Just two months ago, I received the first bottle of the vaccine. Today, we already have 25,000 vaccine doses.”
Prof. Shmuel Shapira, IIBR Director, stressed the importance of this stage in the vaccine’s development. “I am confident in our vaccine, I believe in it and in the ability of the institute scientists who developed it,” he said.
The Phase I human trial for COVID-19 will be completed at Sheba Medical Center and Hadassah University Medical Center in Jerusalem, on 80 healthy volunteers between the ages of 18 and 55. The trial, which will last several months, will be launched on November 1, with only two volunteers.
Once the response of the initial two volunteers is gauged, the rest of the volunteers will gradually receive the vaccine candidate. Each medical center will be administering it to 40 people, some of whom will receive a placebo. They will then be monitored over a three-week span to determine if the vaccine causes any side effects. Researchers will also assess each volunteer’s development of antibodies to the novel coronavirus.
Upon completion of Phase I, Phase II will begin, testing the vaccine on 960 healthy volunteers over 18 years old. This part of the trial is expected to commence in December at medical centers nationwide. The goal will be to complete safety screening and identify precise dosage, while continuing to measure the vaccine’s effectiveness.
If both Phase I and Phase II are considered successful, a trial of 30,000 volunteers will start next April or May – comprising Phase III of the trial. After this final stage, the vaccine can receive approval and the public can be vaccinated against COVID-19.
According to the IIBR, their vaccine candidate is based on a well-recognized model of vaccination. However, what’s new about it is the use of a vesicular stomatitis virus (VSV), a type of virus that doesn’t lead to disease in humans. Genetic engineering is used to attach proteins to VSV, which form coronavirus “crowns.” In response, the body identifies the virus as COVID-19 and produces antibodies against it.
Animal models have been established to test safety and efficacy of vaccines and treatments, and according to news reports, IIBR’s vaccine already underwent testing on pigs and was determined to be effective.
For years already, IIBR has been preparing for an unknown threat like coronavirus. As part of this initiative, the institute had already set up a national infrastructure for the rapid identification of epidemic pathogens. Additionally, they had developed tools to facilitate faster vaccine planning in response to an outbreak. New infrastructure has been designed and set up for quick, efficient production of vaccines under stringent regulatory conditions – enabling the manufacture of millions of vaccines; IIBR has the potential to produce 15 million doses.
“I would like to thank the dozens of researchers who worked day and night on this national mission,” said Gantz. “In these difficult times, you are the unit that paves the way for the citizens of Israel.”