Brilife (IIBR-100) / Israel Institute for Biological Research - LARVOL DELTA

BRILIFE001: Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. (clinicaltrials.gov) - P2/3 | N=0 | Withdrawn | Sponsor: NeuroRx, Inc. | Phase classification: P2b ➔ P2/3 | N=20000 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Head-to-Head • Phase classification • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (clinicaltrials.gov) - P1/2 | N=843 | Completed | Sponsor: Israel Institute for Biological Research (IIBR) | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Neutralization of SARS-CoV-2 Variants by rVSV-ΔG-Spike-Elicited Human Sera. (PubMed, Vaccines (Basel)) - "Taken together, we show that human sera from BriLife vaccinees overall maintain a neutralizing antibody response against all tested variants. We suggest that BriLife-acquired mutations may prove advantageous against future SARS-CoV-2 VOCs."

Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

BRILIFE001: Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine. (clinicaltrials.gov) - P2b; N=20000; Not yet recruiting; Sponsor: NeuroRx, Inc.; N=550 ➔ 20000

Clinical • Enrollment change • Head-to-Head • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

BRILIFE001: Phase 2b Dose-confirmatory Trial to Evaluate the Safety, Immunogenicity and Potential Efficacy of an VSV-ΔG SARS-CoV-2 Vaccine (clinicaltrials.gov) - P2b; N=550; Not yet recruiting; Sponsor: NeuroRx, Inc.

New P2b trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Israel set to start second phase of human trials of its COVID-19 vaccine candidate (New Indian Express) - P1/2, N=1040; NCT04608305; "Israel is set to start the second phase of human clinical trials of its COVID-19 vaccine candidate, named Brilife, in the coming days...The second phase of the human trial will involve the participation of approximately 1,000 volunteers....'During the first phase, no significant side effects were identified, and two expert committees, both internal and external recommended the approval of the second phase....Its success will enable the launch of a large-scale trial to test the effectiveness of the vaccine with the participation of up to 30,000 volunteers...The three stages of the human clinical trial involving over 30,000 volunteers are likely to last till almost mid-2021..."

P1 data • Trial status • Infectious Disease • Novel Coronavirus Disease

Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (clinicaltrials.gov) - P1/2; N=1040; Recruiting; Sponsor: Israel Institute for Biological Research (IIBR); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (clinicaltrials.gov) - P1/2; N=1040; Not yet recruiting; Sponsor: Israel Institute for Biological Research (IIBR)

Clinical • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease

Israel starts human trials of COVID-19 vaccine as schools slowly reopen (Reuters) - "Israel began human trials on Sunday for its COVID-19 vaccine candidate which, if successful, could be ready for the general public by the end of next summer. Eighty volunteers will initially take part in the trial that will be expanded to 960 people in December....The first batch of volunteers received the potential vaccine..."

Trial status • Infectious Disease • Novel Coronavirus Disease

Israel to start COVID-19 vaccine human trials on Nov. 1 (Reuters) - "Israel will begin human trials for a potential COVID-19 vaccine...on Nov. 1 after receiving regulatory approval....Eighty volunteers aged between 18 and 55 will be monitored for three weeks to see if virus antibodies develop....A second phase, expected to begin in December, will involve 960 people over the age of 18. Should those succeed, a third, large-scale phase with 30,000 volunteers is scheduled for April/May. If successful, the vaccine may then be approved for mass use....IIBR has produced more than 25,000 doses for the first and second phases of the clinical trials."

Clinical • New P3 trial • Trial initiation date • Infectious Disease • Novel Coronavirus Disease