Phase 2b/3 Trial of VSV-ΔG SARS-CoV-2 Vaccine (BRILIFE) Against Approved Comparator Vaccine.

NCT04990466 | Withdrawn Phase 2 DMC

• 1 other identifier: BriLife_001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

COVID-19

Keywords

COVID-19; SARS-CoV-2; Delta Variant; BRILIFE; VSV-ΔG

Outcome Measures

Primary Outcomes (1)

• Prevention of Serology-confirmed SARS-CoV-2 infection

  Prevention of serology confirmed infection (seroconversion to non-vaccine antigen) in Prevention of PCR+ COVID-19 in combination with one or more of the clinical symptoms

  180 days

Secondary Outcomes (4)

• Prevention of COVID-19 mild/moderate disease

  Beginning 14 days after second injection

• Prevention of COVID-19 severe disease

  Beginning 14 days after second injection

• Serologic Immunogenicity

  365 days

• Cellular Immunogenicity

  365 days

Study Arms (2)

Active Vaccine

EXPERIMENTAL

IIBR-100 (VSV-ΔG) vaccine at 10 to the 8th strength in prime/boost separated by 28 days

Drug: IIBR-100

Active Comparator

ACTIVE COMPARATOR

A currently approved vaccine for COVID-19 administered in prime/boost separated by 28 days

Drug: Active Comparator

Interventions

IIBR-100 DRUG

Administration of IIBR-100 vaccine

Active Vaccine

Active Comparator DRUG

Administration of a currently-approved vaccine for COVID-19

Active Comparator

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• No clinically significant abnormalities in hematology, blood chemistry, or urinalysis laboratory tests at screening.
• Must agree not to enroll in another study of an investigational agent prior to completion of the study.
• Normal oral temperature, pulse rate no greater than 100 beats per minute (sinus rhythm) and controlled blood pressure (in the case of hypertensives under treatment, below 140/90 mmHg).
• 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 -

You may not qualify if:

• 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 (except of confirmed placebo in IIBR20-001 study) up to 30 days prior to screening or ongoing participation in another clinical trial (except of IIBR20-001 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 (subjects treated by anticoagulation or anti platelets are not excluded).
• New onset of fever \>37.8ºC AND \[cough OR shortness of breath OR anosmia/ageusia\], or any other inter current illness within 14 days prior to screening
• Factors that increase risk to the subject to severe disease per CDC guidance including the following risk factors (in any case of ambiguous grading, decision will be made per investigator's best clinical judgement): Cancer \[ongoing malignancy or recently diagnosed malignancy in the last five years, not including non-melanotic skin cancer\], Chronic Kidney Disease (eGFR\<60 mL/min/1.73 m\^2), liver disease (ALT or AST) \> 1.5 × ULN; or alkaline phosphatase and direct bilirubin \> ULN (total bilirubin may be up to 2 × ULN as long as direct bilirubin is equal to or below the ULN); or PT INR \> 1.25), COPD; Immunocompromised state from solid organ transplant; Obesity (BMI≥30kg/m2); Serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies; Sickle cell disease; Type 1/2 diabetes mellitus (HbA1C\>8.0%, per medical history questioning or records) ); Asthma; Cerebrovascular disease; Cystic fibrosis, uncontrolled hypertension that does not respond to therapy, Pulmonary fibrosis, Thalassemia.
• Anticipating the need for immunosuppressive treatment within the next 6 months. Clinically significant (by means of potentially risking the subject or that would be potentially detrimental to the results of the study) medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health or for severe COVID-19, per the investigator.
• Any progressive or severe neurologic condition/disorder, dementia, seizure disorder, or history of Guillian-Barré syndrome.
• Known or suspected impairment of the immune system including rheumatic, connective tissue or vascular disease of autoimmune origin
• Clinically significant abnormal CBC results in WBC, hemoglobin, hematocrit, or platelets.
• Clinically significant abnormal urinalysis: RBC, protein, or glucose only.
• Positive serology for: hepatitis B surface antigen, hepatitis C, HIV.
• Known or suspected illness caused by coronaviruses, SARS-CoV 1, and Middle East Respiratory Syndrome (MERS)-CoV..
• Received any prior vaccine against a coronavirus.

Sponsors & Collaborators

• NeuroRx, Inc.: lead

MeSH Terms

Conditions

COVID-19

Interventions

rVSV-deltaG-spike COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jonathan C Javitt, MD, MPH

  NRx Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All vaccinations will be prepared by a single, unblinded research pharmacist in a site removed from the clinical immunization site
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, comparator-controlled non-inferiority trial

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 4, 2021
• Study Start: September 30, 2021
• Primary Completion: December 31, 2021
• Study Completion: February 28, 2022
• Last Updated: January 19, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Protocol, SAP, and ICF will be shared prior to first patient visit. CSR will be shared following regulatory determination
• Access Criteria: all qualified researchers