NIH begin testing remsesier plus beta-1a; Israel to start human vaccine tests

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NIH begin testing remsesier plus beta-1a; Israel to start human vaccine tests

A randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in patients with coronavirus disease 2019 (COVID-19) has begun. The study, called the Adaptive COVID-19 Treatment Trial 3 (ACTT 3), is anticipated to enroll more than 1,000 hospitalized adults with COVID-19 at as many as 100 sites in the United States and abroad. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring the trial.

ACTT 3 is the third iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT). ACTT began on Feb. 21 to evaluate remdesivir, an investigational broad-spectrum antiviral discovered and developed by Gilead Sciences, Inc, of Foster City, California. A preliminary analysis of ACTT data found that patients who received remdesivir had a statistically significant shorter time to recovery compared to patients who received placebo. These results were published on May 22. More detailed information about the results, including more comprehensive data, will be available in a forthcoming report.

Subcutaneous interferon beta-1a, a medication manufactured by Merck KGaA, Darmstadt, Germany, is approved in the U.S. and more than 90 other countries for the treatment of multiple sclerosis. The drug is marketed under the brand name Rebif by EMD Serono, the North American biopharmaceutical business of Merck KGaA, Darmstadt, Germany. Interferon beta-1a has the same amino acid sequence as a naturally occurring protein called interferon beta, which is part of a class of proteins called type 1 interferons. Infected cells normally produce type 1 interferons to help the immune system fight pathogens, especially viruses. Interferon beta has both antiviral and anti-inflammatory properties.

Laboratory studies suggest that the normal interferon response is suppressed in some people after infection with SARS-CoV-2, the virus that causes COVID-19. In the laboratory, type 1 interferon can inhibit SARS-CoV-2 and two closely related viruses, SARS-CoV and MERS-CoV. In addition, two small randomized controlled trials suggest that treatment with interferon beta may benefit patients with COVID-19. The combination of interferon beta-1a and remdesivir for treating COVID-19 has not been evaluated in a large, randomized controlled trial.

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Shapira, at the laboratory in Ness Ziona on August 6, 2020. (Ariel Hermoni/ Defense Ministry)

An Israeli national laboratory will begin testing its coronavirus vaccine on human subjects in mid-October, Defense Minister Benny Gantz announced Thursday.

Gantz made the remarks following a visit to the Defense Ministry’s secretive Institute for Biological Research in Ness Ziona, where he was informed of recent “advancements in the development of the vaccine and antibodies for the coronavirus,” his office said.

According to the defense minister, initial tests of the vaccine have been promising, allowing for human trials....

An Israeli national laboratory will begin testing its coronavirus vaccine on human subjects in mid-October, Defense Minister Benny Gantz announced Thursday.

Gantz made the remarks following a visit to the Defense Ministry’s secretive Institute for Biological Research in Ness Ziona, where he was informed of recent “advancements in the development of the vaccine and antibodies for the coronavirus,” his office said.

According to the defense minister, initial tests of the vaccine have been promising, allowing for human trials.

“We should begin tests on people after the Tishrei holidays,” Gantz said, referring to the Hebrew month in which the Jewish High Holidays take place, the last of which ends on October 10. “This will be done in coordination with the Health Ministry and according to the protocols needed in terms of medical safety.”

The director of the Institute for Biological Research, Prof. Shmuel Shapira, said he believed that the vaccine would be successful....

Last month, Channel 12 news reported that the institute had made significant progress on the vaccine, achieving nearly 100 percent efficacy in animals.

The vaccine under development is on par in effectiveness with a vaccine being developed by US biotechnology company Moderna, according to the TV report.

In June, Israel signed a deal with Moderna for the potential purchase of its coronavirus vaccine if it proves effective.

Unlike vaccines developed abroad, the domestic vaccine will first be delivered to Israeli citizens, it added. If successful, it was expected to provide protection against the disease with a single dose.

Though it had not started human trials, the institute was preparing to manufacture 10 to 15 million doses, report said. In June, the institute announced it had completed successful coronavirus vaccine trials on rodents

 

 

 

 

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