Israel to dose last BriLife Phase II trial participant on Sunday
The Phase II trial had been approved and kicked off in December 2020, around the time the first vaccines arrived in Israel
By MAAYAN JAFFE-HOFFMAN , Jerusalem Post, SEPTEMBER 18, 2021
Hadassah-University Medical Center's Prof. Yossi Karko (left) and Hannah Drori, chief of the hospital’s clinical research center, administer Brilife vaccine to a volunteer (photo credit: HADASSAH)
The last volunteer of Israel’s BriLife vaccine Phase II clinical trial will be dosed on Sunday, according to Eytan Ben-Ami, head of early phase clinical trials at Sheba Medical Center.
The data from the trial of more than 700 people should be analyzed in October and then the research team will be able to make a decision about whether or not to continue to Phase III.
The Phase II trial was approved and kicked off in December 2020, around the time that the first vaccines arrived in Israel. Ben-Ami said that the volunteers would be monitored for a year.
The BriLife vaccine was developed by the Israel Institute for Biological Research (IIBR) in Ness Ziona, which is under the auspices of the Defense Ministry. The ministry in July inked a deal with US-based pharmaceutical company NRx to help fast-track the vaccine.
BriLife is currently undergoing a Phase IIb trial in Georgia that is being overseen by NRx, which now has exclusive worldwide development, manufacturing and marketing rights.
In Israel, four doses of the BriLife vaccine were tested as part of the Phase II trial – low, medium, high and a “top dose,” Prof. Yossi Caraco, head of the Clinical Pharmacology Unit at Hadassah-University Medical Center, explained. The highest dose seemed to be the most effective, he said, and the results seem “very promising” – although no final evaluation has been made.
BriLife is a vector-based vaccine. The vaccine takes the vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope.
Once injected, it does not cause a disease by itself. VSV does not infect humans; instead, the body recognizes the spike protein that is expressed on the envelope and begins to develop an immunological response. The vaccine will initially be delivered by traditional injection.
“The BriLife vaccine differs from other COVID-19 vaccines by presenting the entire COVID-19 spike protein to the body’s immune system,” explained NRx in a release. “It also differs from other COVID-19 vaccine approaches in that it is a self-propagating, live-virus vaccine in which the spike protein of the vaccine appears to evolve in a manner consistent with the evolution of the SARS-CoV-2 virus in nature.
“Thus, while variants may arise that support manual enrichment of the vaccine against those specific variants, the vaccine itself may continue to evolve in a manner that provides ongoing protection against variants,” the release said.
Rx chairman Prof. Jonathan Javitt told The Jerusalem Post in August that the goal is to launch a Phase III trial by October. That trial will be across multiple countries, including Georgia and Ukraine, and will include up to 30,000 people.