Israel kicks off coronavirus vaccine human trial Sunday

Written by on October 31, 2020

Patients will be injected at Sheba Medical Center and Hadassah Ein Kerem

IIBR's vaccine candidate arrived at Hadassah and was placed in the deep-freezer (photo credit: Courtesy)

IIBR’s vaccine candidate arrived at Hadassah and was placed in the deep-freezer

(photo credit: Courtesy)

The country will kick-off its human trial of Brilife, its coronavirus vaccine candidate, on Sunday by injecting two people – one at Hadassah Ein Kerem and one at Sheba Medical Center at Tel Hashomer.

The vaccine was developed by the Israel Institute for Biological Research and was delivered to the hospitals last Thursday to be stored in the deep-freeze until Sunday morning.

Hadassah’s first candidate in the Phase I trial will be a 34-year-old male doctoral student from southern Israel.

The individual who was meant to be the first person to receive the vaccine at Sheba was disqualified, after he was found to have antibodies against the virus, the hospital confirmed.

Boaz Kolodner, 47, from Moshav Ganei Hadar,  was one of three finalists to be injected with the vaccine. But when the hospital ran a serological test on Kolodner on Thursday, doctors discovered that he had been infected with coronavirus and recovered from the virus without knowing it.

A second, younger volunteer, has been selected, Sheba said, but would not reveal any additional information.

The first injections will be given at around the same time in the morning at both hospitals. The head of IIBR, Prof. Shmuel Shapira, and Defense Minister Benny Gantz, will be present at Seba.

Sheba’s first volunteer will stay overnight in the cardiology ward for monitoring. If he is found healthy, he will be released home. Then, by Tuesday or Wednesday, additional volunteers will be brought in for vaccination.

Ultimately, the Phase I human trial will be conducted on 80 healthy volunteers between the ages of 18 and 55. Each volunteer will be monitored over the course of three weeks to determine if there are any side effects caused by the vaccine. Researchers will also examine whether volunteers develop antibodies to coronavirus, which leads to immunity.

When Phase I is completed, if successful, Phase II will commence, testing the vaccine on 960 healthy volunteers over the age of 18. Phase II is expected to begin in December at medical centers across the country. That phase is meant to complete safety tests and pinpoint the right doses, as well as to continue to gauge effectiveness.

If the first two phases are successful, a Phase III trial of 30,000 volunteers will begin next April or May for the final stage. Once completed, the vaccine can be approved, and the population can be vaccinated against the virus.

A spokesperson for Sheba said that IIBR is not vying for European or FDA approval at this stage.

The country’s development of a vaccine is considered the most significant step toward being able to beat coronavirus.

Speaking Thursday evening, Prime Minister Benjamin Netanyahu said that a vaccine is the only way out of the pandemic, and that Israel was working on multiple fronts to obtain one. These include developing its own, purchasing promising vaccine candidates and negotiating with other countries to be able to acquire doses through them, if needed.

IIBR’s vaccine candidate is based on a well-known method of vaccination, the institute has said. What is new is the use of a vesicular stomatitis virus (VSV) – a type of virus that does not cause diseases in humans. Through genetic engineering, proteins are attached to the VSV virus to form coronavirus “crowns” that are identified by the body as COVID-19. As a result, the body produces antibodies against it.

The vaccine has already been tested on pigs and found to be effective.

The name of Israel’s vaccine has meaning in Hebrew. The “bri” is the first part of the Hebrew word for health; the “il” stands for Israel and “life,” explained IIBR director-general Prof. Shmuel Shapira.

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