A Phase IIb/3 Randomized, Multi-Center, Placebo-Controlled Noninferiority Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults Compared to an Approved COVID-19 Vaccine

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.

开始日期2021-09-30

申办/合作机构

NeuroRx, Inc.

100 项与 IIBR-100 相关的临床结果

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100 项与 IIBR-100 相关的专利（医药）

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项与 IIBR-100 相关的文献（医药）

2025-11-01·VACCINE

Using the vesicular stomatitis virus vector (rVSV vector) platform for SARS-CoV-2 vaccine development: Phase 1/2 safety and immunogenicity of IIBR-100 in healthy adults

Article

作者: Madar-Balakirski, Noa ; Levin, Yotam ; Maayan, Shlomo ; Zeltser, David ; Beth-Din, Adi ; Atsmon, Jacob ; Ben-Ami, Eytan ; Cohen, Daniel ; Caraco, Yoseph ; Paran, Nir ; Eliakim-Raz, Noa ; Marcus, Hadar ; Vishlitzky, Victor ; Panet, Amos ; Danon, Yehuda ; Shapira, Shmuel ; Yitzhaki, Shmuel ; Bar-Haim, Erez ; Brosh-Nissimov, Tal ; Goldstaub, Dan ; Peer, Avivit ; Israely, Tomer ; Hoggeg, Matti ; Fisher, Morly

BACKGROUND:

We investigated the safety and immunogenicity of the IIBR-100 (rVSV-SARS-CoV-2-S) vaccine, a recombinant VSV-ΔG-spike vaccine against SARS-CoV-2 virus.

METHODS:

In a phase 1/2, randomized, observer-blind, placebo-controlled study (ClinicalTrials.gov: NCT04608305), healthy younger (18-55 years) and older (56-85 years) adults were recruited from eight clinical sites in Israel. In the phase 1 study, low (1 × 10⁵ PFU), mid (1 × 10⁶ PFU), and high doses (1 × 10⁷ PFU) of IIBR-100 were tested in a single-dose treatment regimen, with an additional booster dose for the low-dose group only. Based on the phase 1 study results, only mid- and high-dose prime-boost regimens alongside an additional top dose (1 × 10⁸ PFU) were tested in the phase 2 study. Participants, randomly assigned to either IIBR-100 or placebo, were followed for 12 months from the last vaccination for safety and immunogenicity outcomes.

FINDINGS:

No safety concerns were observed in the phase 1 study (N = 82); therefore, the study moved on to phase 2. In phase 2 (N = 762), for both age groups, the most common AEs included injection-site pain (20-64 %), fatigue (21-33 %), and headache (15-22 %). In the top-dose group, neutralizing and binding antibody titers peaked on Days 35 and 42, respectively; seroconversion rates reached maximal levels by Day 56 for neutralizing antibody and binding antibody (spike and RBD).

INTERPRETATION:

The IIBR-100 vaccine against SARS-CoV-2 in prime-boost regimens at 1 × 10⁷ PFU/mL and 1 × 10⁸ PFU/mL doses is safe, well tolerated, and immunogenic in healthy adults.

CLINICAL TRIAL REGISTRY:

This trial is registered at ClinicalTrials.gov (NCT04608305) and in the trial registry of the Israeli Ministry of Health website.

100 项与 IIBR-100 相关的药物交易

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