Clinical Trials Logo

Clinical Trial Summary

IIBR-100 (VSV-ΔG) is a self-propagating live virus vaccine that contains the spike protein of the Wuhan wild-type SARS-CoV-2 virus. Preclinical and phase 1/2 trials have demonstrated no safety signals of concern and have further demonstrated immunologic response that approximates the response seen in convalescent individuals. The purpose of this phase 2b/3 trial is to document the non-inferiority of IIBR-100 vs. an already-approved vaccine for COVID-19.

Clinical Trial Description

STUDY RATIONALE: The SARS-CoV-2 virus is responsible for the COVID-19 pandemic, perhaps the deadliest in 100 years. The pandemic emerged from Wuhan Province in China in December 2019 and was declared by the WHO Director-General a Public Health Emergency of International Concern on 30 January 2020. Early cases have been reported in Israel around February 2020, and at the time this protocol is being drafted. The virus has spread to 190 countries with more than 198 million confirmed cases and more than 4.2 million confirmed deaths as of August 2, 2021 (WHO website In an effort to curb the pandemic, the Israel Institute for Biological Research (IIBR) has developed a replication-competent recombinant VSVΔG-spike vaccine (rVSV-SARS-CoV-2-S, IIBR-100), in which the glycoprotein of VSV is replaced by the spike protein of the SARS-CoV-2 virus. Pre-clinical data suggested IIBR-100 as a safe, efficacious, and protective vaccine against SARS-CoV-2 infection. In addition, clinical experience from over 20,000 subjects vaccinated with Ervebo®, an Ebola vaccine developed by Merck & Co. and licensed by FDA in 2019, also supports the safety of the VSV-ΔG backbone. An overlapping Phase I/II study in Israel is showing a good safety profile. This study is intended to support late-stage clinical studies and eventual mass immunization of the Georgian population. STUDY DESIGN: This is a Phase IIb/3, prospective, randomized, comparator-controlled, observer-blind, multi-center non-inferiority study. Subjects will receive two intramuscular (IM) injections of the IIBR-100 (prime-boost) separated by 28 days consisted of 1 ml replicating viral rVSV SARS-CoV-2-S vaccine or active comparator. Injection will be performed at Day 0 and Day 28±2d in the deltoid muscle and will be followed through 12 months post last vaccination. Follow-up (FU) visits will occur 1, 2 and 4 weeks, as well as, 2 ,3, 6, 9, and 12 months post last vaccination. The primary outcome will be PCR+ infection with COVID-19 six months after vaccination. Key secondary outcome will be serologic immunity. Reactogenicity will be assessed at these visits, and blood will be drawn for immunogenicity assays. Additional safety and reactogenicity data will be solicited via electronic diary and telephone calls to subjects performed 1 and 2 days post each vaccination. Reactogenicity will be measured by the occurrence of solicited injection site reaction and systemic reaction from the time of each vaccination through 7 days post each vaccination. Unsolicited non-serious Adverse Events (AEs), Serious adverse events (SAEs), new-onset chronic medical conditions (NOCMCs) and medically-attended adverse events (MAAEs) will be collected through 12 months after the last vaccination. Clinical safety laboratory evaluations will be performed at screening, as well as immediately prior to and 7 days post each vaccination. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT04990466
Study type Interventional
Source NeuroRx, Inc.
Contact Jonathan C Javitt, MD, MPH
Phone 484-254-6134
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date September 30, 2021
Completion date February 28, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Active, not recruiting NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Active, not recruiting NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Active, not recruiting NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Enrolling by invitation NCT05089305 - Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection Phase 2
Recruiting NCT04528901 - Study of seroPREvalence Vis-à-vis SARS-CoV2 and Correlation With Clinical Forms of COVID-19 in Patients Followed in Pneumology in the Cluster Area of the Grand-Est Region (Strasbourg University Hospital)
Recruiting NCT04357990 - Viruxal Oral and Nasal Spray for Treating the Symptoms of COVID-19 N/A
Active, not recruiting NCT04527471 - Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19 Phase 2
Recruiting NCT05041907 - Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) Phase 2
Active, not recruiting NCT05022329 - COVID-19 Vaccine Boosters in Patients With CKD Phase 2/Phase 3
Recruiting NCT05323799 - The Optimising Isolation, Quarantine and Distancing Study for COVID-19 (Optimise)
Recruiting NCT04661462 - Health After Covid-19 in Tyrol
Not yet recruiting NCT04446065 - Previfenon® as Chemoprophylaxis of COVID-19 in Health Workers Phase 2/Phase 3