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.

Conditions

• Covid19

Interventions

BIOLOGICAL

IIBR-100, low dose (prime)

Single administration of IIBR-100 1\*10E5 pfu/ml

BIOLOGICAL

IIBR-100 medium dose (prime)

Single administration of IIBR-100 1\*10E6 pfu/ml

BIOLOGICAL

IIBR-100 high-dose (prime)

Single administration of IIBR-100 1\*10E7 pfu/ml

BIOLOGICAL

IIBR-100 low-dose (prime-boost)

Two administrations of IIBR-100 1\*10E5 pfu/ml, 28 days apart

OTHER

Saline Placebo (single)

Single administration of saline placebo

OTHER

Saline Placebo (double)

Two administrations of saline placebo, 28 days apart

BIOLOGICAL

IIBR-100 medium-dose (prime-boost)

Two administrations of IIBR-100 1\*10E6 pfu/ml, 28 days apart

BIOLOGICAL

IIBR-100 high-dose (prime-boost)

Two administrations of IIBR-100 1\*10E7 pfu/ml, 28 days apart

BIOLOGICAL

IIBR-100 top-dose (prime-boost)

Two administrations of IIBR-100 1\*10E8 pfu/ml, 28 days apart

Sponsors & Collaborators

• Israel Institute for Biological Research (IIBR)

  lead OTHER_GOV

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-10-28

Primary Completion

2022-10-03

Completion

2022-10-03

Countries

• Israel

Study Locations