Sheba begins recruiting volunteers for Israeli COVID-19 vaccine trial
Some volunteers will receive the vaccine and others will be assigned to a control group and receive a placebo.
By MAAYAN JAFFE-HOFFMANSheba Medical Center team at the Coronavirus isolation ward of Sheba Medical Center unit, in Ramat Gan, June 30, 2020.(photo credit: YOSSI ZELIGER/FLASH90)
Sheba Medical Center is actively recruiting its share of the 100 people who will take part in the Phase 1/2 clinical trial of a coronavirus vaccine candidate being developed by the Israel Institute for Biological Research.“After Sukkot, recruitment will begin at Sheba for research of a coronavirus vaccine developed in Israel,” an email that was sent to Sheba employees read.The Jerusalem Post received a copy of the email and confirmed its origin. The email, dated October 4, was directed to all hospital employees.According to the email, individuals over the age of 18 who have not had coronavirus in the past or who don’t have it at the time of their enrollment will be eligible for the study. A source in the know said the trial is open specifically to people between the ages of 18 and 55. Participants cannot be taking any daily medications to participate.Some volunteers will receive the vaccine and others will be assigned to a control group and receive a placebo.“The chance of getting the vaccine is three times greater than the chance of getting a placebo,” the email said.The suitability of volunteers will be verified. Once enrolled, they will be vaccinated and then checked at various intervals several times over the course of a year. All examinations will take place at Sheba and involve a blood test, doctor’s examination and other screenings as requested.This first phase is meant to test the safety of the vaccine. If it is proven to have no significant side effects, the trial will be extended to another 1,000 patients at additional medical centers around the country.A Phase 3 trial would involve 30,000 volunteers.A spokesperson for the hospital confirmed that recruitment for the trial was underway but he could not discuss details. He said that recruitment was happening from within a variety of sectors and that the trials would not begin until late October or early November.
The trial requires the approval of the Health Ministry’s Helsinki Committee, which oversees the rights, safety and well-being of participants recruited for medical research. Such approval has not yet been granted.A senior Health Ministry official told the Post that the approval process was advancing and they hoped to complete it by the end of the month.The trial is being conducted in collaboration with Hadassah Medical Center. Hadassah head Prof. Zeev Rotstein said that his hospital had already started recruiting and was ready to begin testing as early as Sunday, but that he had not yet received the green light.Recall that Prime Minister Benjamin Netanyahu and the Defense Ministry told the public in August that IIBR would be testing its vaccine on humans by mid-October, after the High Holy Days.“The trials are only starting in October because “there are regulatory processes that the vaccine needs to go through,” the Defense Ministry said then. The Prime Minister’s Office added that IIBR was waiting until after the High Holy Days to minimize the health risks involved in human testing.IIBR’s vaccine candidate was tested successfully on hamsters. The institute announced in June that hamsters that were given the vaccine and later exposed to the contagion did not contract the coronavirus.The potential Israeli vaccine is based on a well-known method of vaccination, the institute said in a report. What is new is the use of vesicular stomatitis virus (VSV) – a type of virus that does not cause disease in humans.Through genetic engineering, proteins are attached to the vesicular stomatitis virus to form coronavirus “crowns” that are identified by the body as COVID-19. As a result, the body produces antibodies against it.
