Evaluate the Safety, Immunogenicity and Potential Efficacy of an rVSV-SARS-CoV-2-S Vaccine
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
1 other identifier
interventional
843
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Oct 2020
Longer than P75 for phase_1 covid19
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedStudy Start
First participant enrolled
October 28, 2020
CompletedFirst Posted
Study publicly available on registry
October 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2022
CompletedNovember 18, 2023
November 1, 2023
1.9 years
October 26, 2020
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Phase I and II - The number, grade and percentage of study participants who experience any study injection-associated AEs or SAEs.
* Solicited events for 7 days after vaccination. * Unsolicited events through 28 days after vaccination. * SAEs 365 days after last vaccination * New Onset Chronic Medical Condition (NOCMC) or Medically Attended AE (MAAE) 365 days after last vaccination.
365 days post last vaccination
Phase II - IIBR-100 Immunogenicity by determining neutralizing antibody titers to SARS-CoV-2
Immunogenicity will be determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 per group at 28 days following last vaccination (in relation to Day 0-baseline).
28 days post last vaccination
Secondary Outcomes (3)
Phase I and II - IIBR-100 Immunogenicity as determined by GMT, GMFR, Seroconversion rates of the neutralizing antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study
365 days post last vaccination
Phase I and II - IIBR-100 immunogenicity as determined by GMT, GMFR, Seroconversion rates of the binding antibody titers to SARS-CoV-2 at baseline (day 0) and throughout the study
365 days post last vaccination
Phase I and II - Cellular immunogenicity as assessed by ELISPOT and ELISA.
365 days post last vaccination
Other Outcomes (4)
Phase I and II - Potential efficacy of IIBR-100 vaccine by means of prevention of COVID-19 disease (as defined by FDA Guidance)
14 days post last vaccination
Phase I and II - Potential efficacy of IIBR-100 vaccine by means of prevention of COVID-19 Severe Disease (per FDA Guidance)
14 days post last vaccination
Phase I and II - Potential efficacy of IIBR-100 vaccine by means of serology confirmed infection (seroconversion to non-vaccine antigen) in combination with one or more of the clinical symptoms proposed.
14 days post last vaccination
- +1 more other outcomes
Study Arms (18)
phase I - Group Ia, prime, low dose
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E5 pfu/ml or saline placebo at day 0
phase I - Group Ib, Prime, medium dose
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E6 pfu/ml or saline placebo at day 0
phase I - Group Ic, Prime, high dose
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E7 pfu/ml or saline placebo at day 0
phase I - Group Id, prime-boost, low dose
EXPERIMENTALMale and female subjects (18-55 years old) administered twice with IIBR-100 1\*10E5 pfu/ml or saline placebo, 4 weeks apart, at days 0 and 28.
phase II - Group IIa, prime, low dose*
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E5 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
Phase II - Group IIb, Prime, low dose, elderly subjects*
EXPERIMENTALMale and female subjects (56-85 years old) administered with a single-dose of IIBR-100 1\*10E5 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
phase II - Group IIc, Prime, medium dose*
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E6 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
phase II - Group IId, Prime, medium dose, elderly subjects*
EXPERIMENTALMale and female subjects (56-85 years old) administered with a single-dose of IIBR-100 1\*10E6 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
Phase II - Group IIe, prime, high dose*
EXPERIMENTALMale and female subjects (18-55 years old) administered with a single-dose of IIBR-100 1\*10E7 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
Phase II - Group IIf, Prime, high dose, elderly subjects*
EXPERIMENTALMale and female subjects (56-85 years old) administered with a single-dose of IIBR-100 1\*10E7 pfu/ml or saline placebo at day 0. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
phase II - Group IIg, prime-boost, low dose*
EXPERIMENTALMale and female subjects (18-55 years old) administered twice with IIBR-100 1\*10E5 pfu/ml or saline placebo, 4 weeks apart at days 0 and 28. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
phase II - Group IIh, prime-boost, low dose, elderly subjects*
EXPERIMENTALMale and female subjects (56-85 years old) administered twice with IIBR-100 1\*10E5 pfu/ml or saline placebo, 4 weeks apart, at days 0 and 28. \*Treatment arm was deactivated based on immunogenicity data and DSMB recommendations.
phase II - Group IIi, prime-boost, medium dose
EXPERIMENTALMale and female subjects (18-55 years old) administered twice with IIBR-100 1\*10E6 pfu/ml or saline placebo, 4 weeks apart at days 0 and 28.
phase II - Group IIj, prime-boost, medium dose, elderly subjects
EXPERIMENTALMale and female subjects (56-85 years old) administered twice with IIBR-100 1\*10E6 pfu/ml or saline placebo, 4 weeks apart, at days 0 and 28.
phase II - Group IIk, prime-boost, high dose
EXPERIMENTALMale and female subjects (18-55 years old) administered twice with IIBR-100 1\*10E7 pfu/ml or saline placebo, 4 weeks apart at days 0 and 28.
phase II - Group IIl, prime-boost, high dose, elderly subjects
EXPERIMENTALMale and female subjects (56-85 years old) administered twice with IIBR-100 1\*10E7 pfu/ml or saline placebo, 4 weeks apart, at days 0 and 28.
phase II - Group IIm, prime-boost, top dose
EXPERIMENTALMale and female subjects (18-55 years old) administered twice with IIBR-100 1\*10E8 pfu/ml or saline placebo, 4 weeks apart at days 0 and 28.
phase II - Group IIn, prime-boost, top dose, elderly subjects
EXPERIMENTALMale and female subjects (56-85 years old) administered twice with IIBR-100 1\*10E8 pfu/ml or saline placebo, 4 weeks apart, at days 0 and 28.
Interventions
Single administration of IIBR-100 1\*10E5 pfu/ml
Single administration of IIBR-100 1\*10E6 pfu/ml
Single administration of IIBR-100 1\*10E7 pfu/ml
Two administrations of IIBR-100 1\*10E5 pfu/ml, 28 days apart
Single administration of saline placebo
Two administrations of saline placebo, 28 days apart
Two administrations of IIBR-100 1\*10E6 pfu/ml, 28 days apart
Two administrations of IIBR-100 1\*10E7 pfu/ml, 28 days apart
Two administrations of IIBR-100 1\*10E8 pfu/ml, 28 days apart
Eligibility Criteria
You may qualify if:
- Phase I (abbreviated):
- Healthy males or females, ages 18 to 55 (inclusive) at the time of screening.
- Negative PCR and no presence of ELISA antibody titers to SARS-CoV-2 at screening.
- Females of childbearing potential and males must be willing to use effective methods of contraception such as hormones (OCP, oral contraceptive pill), condom or occlusive cap with spermicidal agents, intrauterine device (IUD) or intrauterine system (IUS) from at least 14 days prior to vaccination through 90 days following last injection.
- Subjects in general good health with no chronic disease nor consumes chronic medication in the opinion of the investigator as determined by medical history, vital signs and a physical examination.
- No clinically significant abnormalities in hematology, blood chemistry, or urinalysis laboratory tests at screening.
- Negative HIV, Hepatitis B and Hepatitis C serology tests.
- Normal oral temperature, normal sinus rhythm, pulse rate no greater than 100 beats per minute and normal systolic blood pressure (below 140/90 mmHg)
- Must be willing to forgo blood donation during the blood drawing phase of the study.
- Must agree not to enroll in another study of an investigational agent prior to completion of the study.
- Subjects must be able to understand the requirements of the study and must be accessible and willing to comply with the study procedures even under lock down conditions.
- Ability to provide informed consent.
- Phase II (abbreviated):
- Males or females, ages 18 to 85 (inclusive) at the time of screening.
- Negative PCR and no presence of ELISA antibody titers to SARS-CoV-2 at screening.
- +7 more criteria
You may not qualify if:
- Phase I (abbreviated):
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions or known allergy to the components of the vaccine, including allergy to rice.
- Receipt of investigational product up to 30 days prior to screening or ongoing participation in another clinical trial
- Receipt of licensed vaccines within 14 days of planned study immunization and any AE's possibly related to licensed vaccine immunization at Day 0.
- Inability to observe possible local reactions at the injection sites due to a physical condition or permanent body art.
- Known hemoglobinopathy or coagulation abnormality.
- New onset of fever \>37.8 ÂșC AND \[cough OR shortness of breath OR anosmia/ageusia\] or any other inter current illness within 14 days prior to screening
- High risk of exposure to SARS-CoV-2 prior to enrollment (close contact, self-isolation at present due to household contact, frontline healthcare provider in contact with COVID-19 subjects).
- Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health, per the best clinical judgement of the investigator.
- Women who are pregnant or breastfeeding.
- Positive urine pregnancy test or women have an intention to be pregnant during the study.
- Confirmed or suspected illness caused by coronaviruses, SARS-CoV 1, and Middle East Respiratory Syndrome (MERS)-CoV.
- Received any prior vaccine against a coronavirus
- Receipt of blood/plasma products or immunoglobulin, from within 60 days before study intervention administration or planned receipt throughout the study.
- History of alcohol or drug abuse per clinical judgement within 5 years prior to study vaccination.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Assuta - University Hospital
Ashdod, Israel
Barzilai MC
Ashkelon, Israel
Rambam MC
Haifa, Israel
Hadassah Medical Center
Jerusalem, 91120, Israel
Meir MC
Kfar Saba, Israel
Rabin MC
Petah Tikva, Israel
Sheba Medical Center Hospital- Tel Hashomer
Ramat Gan, 52621, Israel
Sourasky MC
Tel Aviv, Israel
Related Publications (1)
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.
PMID: 41106035DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
October 29, 2020
Study Start
October 28, 2020
Primary Completion
October 3, 2022
Study Completion
October 3, 2022
Last Updated
November 18, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share