Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine

Summary

The SARS-CoV-2 virus is responsible for the COVID-19 pandemic. 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. In this study, a vaccine developed by IIBR for SARS-CoV-2 virus will be assessed for its safety and potential efficacy in volunteers. The study is comprised of two phases, a dose-escalation phase (phase I) during which subjects (18-55 years old) will be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline or two administrations of IIBR-100 at low dose, or saline, 28 days apart. Based on results obtained during phase I, and cumulative phase I data review, the expansion phase (phase II) has begun, during which larger cohorts as well as elderly age subjects were initially planned to be randomly allocated to receive a single administration of IIBR-100 at low, mid or high dose or saline, or two administrations of IIBR-100 at low, mid or high dose (prime-boost) or saline, 28 days apart. Additional top-dose (prime-boost) may be implemented when immunogenicity of any prime-boost arm is considered insufficient. However, based on immunogenicity preliminary data and DSMB recommendations, only the two administrations of mid, high and top dose (prime-boost) or saline will continue in the study. The subjects will be followed for a period of up to 12 months post last vaccine administration to assess the safety and efficacy of the vaccine.

Timeline

Start

2020-10-28

Primary completion

2022-10-03

Completion

2022-10-03

Publications

• Caraco Y, Madar-Balakirski N, Ben-Ami E, Zeltser D, Maayan S, Eliakim-Raz N, Peer A, Brosh-Nissimov T, Vishlitzky V, Beth-Din A, Bar-Haim E, Israely T, Paran N, Fisher M, Hoggeg M, Atsmon J, Cohen D, Goldstaub D, Levin Y, Danon Y, Panet A, Shapira S, Yitzhaki S, Marcus H. 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. Vaccine. 2025 Nov 20;67:127837. doi: 10.1016/j.vaccine.2025.127837. Epub 2025 Oct 16.

Drugs

Indications