Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:08 AM
Study NCT ID:
NCT04608305
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2020-10-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine
Sponsor:
Israel Institute for Biological Research (IIBR)
Organization:
Study Overview
Official Title:
A Phase I/II Randomized, Multi-Center, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine (IIBR-100) in Adults
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
In the Phase I, healthy adult volunteers will be randomly allocated to one of the four treatment groups to receive a single administration (prime) of IIBR-100 at low, mid or high dose or saline or two administrations (prime-boost) of IIBR-100 at low dose, or saline, 28 days apart. During Phase I, dosing of prime will proceed in a sequential fashion followed by a safety review committee and DSMB to consider expansion to include the rest of the group and escalation to the next groups. Only Groups that demonstrate acceptable safety profile, immunogenicity and potential efficacy will be included in the Phase II operation. In both phases, the subjects will receive an intramuscular injection of the IIBR-100 consisted of 1ml replicating viral rVSV SARS-CoV-2-S vaccine or placebo consisted of 1ml of 0.9% saline. Dosing will be performed at Day 0 and Day 28 (for allocated to prime-boost treatment groups) in the deltoid muscle and will be followed through 12 months post last vaccination. Follow-up visits for subjects administered with the single administration (prime) or placebo will occur at 1, 2 and 4 weeks as well as 2, 3, 6, 9 and 12 months after dosing. Follow up visits for subjects administered with two administrations (prime-boost) or placebo will occur at 1, 2 and 4 weeks post each vaccination as well as at 2, 3, 6, 9 and 12 months after the second vaccination. Reactogenicity will be measured by the occurrence of solicited injection site and systemic reactions from the time of each dosing through 7 days post each dosing. Unsolicited non-serious safety events will be collected from the time of each dosing through 28 days post each dosing. Serious safety events, new-onset chronic medical conditions and medically attended safety events will be collected through 12 months after the last dosing.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: