The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine
The Ad26.COV2.S investigational vaccine is being developed to prevent or lessen the severity of COVID-19, the disease caused by Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). The Ad26.COV2.S investigational vaccine is a non-replicating common cold virus vector containing genes that encode the spike protein of the SARS-CoV-2 virus. The goal is to immunize against COVID-19. The investigational vaccine cannot cause colds or COVID-19. The ENSEMBLE study aims to test Janssen’s investigational vaccine for saftey and efficacy in different populations across the globe.
Visit ClinicalTrials.gov and search identifier NCT04505722 for additional details.
AstraZeneca Study of AZD1222
AZD1222 is an investigational vaccine being developed by AstraZeneca to prevent COVID-19, the disease caused by the SARS-CoV-2 virus.
The vaccine is based on a weakened version of a common cold (adenovirus) virus. The adenovirus vaccine has been changed so that it can’t replicate. The vector presents the COVID-19 spike protein to generate an immune response. The purpose of the study is to test how well the investigational vaccine works at preventing COVID-19 disease and how safe it is.
Visit ClinicalTrials.gov and search identifier NCT04516746 for additional details.
Qualified IDCRC Sites:
- Cincinnati Children’s Hospital Medical Center VTEU and Nationwide Children’s subsite
- New York University VTEU
- University of Rochester VTEU
- University of Washington VTEU
Regeneron’s 10933 and 10987 Monoclonal Antibodies, the REGN-COV2 Study
REGN-COV-2 is testing a combination of two specific (monoclonal) antibodies called REGN10933 and REGN10987 to see whether they are able to prevent acquisition or lessen symptoms of SARS-CoV-2. The antibodies are directed at the SARS-CoV-2 spike protein. This study will enroll approximately 2,000 adults in the United States who are living in the same household as a person who has recently tested positive for SARS-CoV-2. This will include about 1,700 participants who test SARS-CoV-2 negative at enrollment and about 300 participants who have a positive SARS-CoV-2 test result but do not yet have any COVID-19 symptoms.
The REGN10933 and REGN10987 antibodies are designed to bind to SARS-CoV-2 spike protein and prevent the virus from entering healthy cells.
Visit ClinicalTrials.gov and search identifier NCT04452318 for additional details.
Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study
BLAZE-2 is testing the LY3819253 specific (monoclonal) antibody. It will be enrolling staff and residents in skilled nursing and assisted living facilities with a high risk of exposure to SARS-CoV-2. The study questions are:
- Does the antibody prevent the acquisition of SARS-CoV-2 in this population?
- Does the antibody help to prevent the development of more severe COVID-19, or does it reduce the symptoms?
The study is being conducted in the United States with up to 2,400 participants. LY3819253 is designed to bind to SARS‑CoV-2 spike protein and prevent the virus from entering healthy cells. Dr. Mark Mulligan from the NYU VTEU is the study Co-PI.
Visit ClinicalTrials.gov and search identifier NCT04497987 for additional details.
Qualified IDCRC Site:
- Baylor College of Medicine VTEU
Moderna’s mRNA-1273 vaccine, The COVE Study™
The mRNA-1273 vaccine is being developed to prevent COVID-19. The purpose of this large phase 3 study is to test Moderna’s vaccine candidate to see if it can prevent COVID-19 illness if people are exposed to the SARS-CoV-2 virus. The mRNA-1273 vaccine is directed at the spike protein of SARS-CoV-2. The vaccine contains messenger ribonucleic acid (mRNA), a genetic code that tells cells how to make protein, and directs the body’s immune system to make antibodies to fight the virus.
Visit ClinicalTrials.gov and search identifier NCT04470427 for additional details.
Partcipating IDCRC Sites:
- Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
- Emory Children's Center - Vaccine Research Center
- The Hope Clinic of the Emory Vaccine Center
- Kaiser Permanente Washington Health Research Institute VTEU
- Saint Louis University VTEU
- University of Maryland School of Medicine VTEU
- Vanderbilt University Medical Center VTEU and subsite University of Pittsburgh
Adaptive COVID-19 Treatment Trial 3 (ACTT 3)
ACTT 3 is randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen consisting of the antiviral remdesivir plus the immunomodulator interferon beta-1a in patients with coronavirus disease 2019 (COVID-19). The study is anticipated to enroll approximately 1,000 hospitalized adults with COVID-19 on low-flow oxygen and those not requiring supplemental oxygen at as many as 100 sites in the United States and abroad. The National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the trial. ACTT 3 is the third study in NIAID’s Adaptive COVID-19 Treatment Trial (ACTT).
Visit ClinicalTrials.gov for additional details.
Partcipating IDCRC Sites:
- University of Alabama at Birmingham
- The Hope Clinic of the Emory VTEU
- University of Maryland School of Medicine VTEU
- Saint Louis University VTEU
- University of Rochester Medical Center VTEU
- Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
Safety and Immunogenicity Study of 2019-nCoV Vaccine (mRNA-1273) for Prophylaxis of SARS-CoV-2 Infection (COVID-19) - COMPLETED
The mRNA-1273 vaccine is being developed to prevent COVID-19. The purpose of the phase 1 study was to test Moderna’s vaccine candidate to see if the vaccine is safe and generates an immune response. The mRNA-1273 vaccine is directed at the spike protein of SARS-CoV-2. It is made from messenger ribonucleic acid (mRNA), the genetic code that tells cells how to make a protein, and directs the body’s immune system to make antibodies to fight the virus.
Visit ClinicalTrials.gov and search identifier NCT04283461 for additional details.
Partcipating IDCRC Sites:
- Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
- Emory Children's Center - Vaccine Research Center
- The Hope Clinic of the Emory Vaccine Center
- Kaiser Permanente Washington Health Research Institute VTEU
- Saint Louis University VTEU
- University of Maryland School of Medicine VTEU
- Vanderbilt University Medical Center VTEU and subsite University of Pittsburgh
Adaptive COVID-19 Treatment Trial 1 (ACTT 1) - COMPLETED
Hospitalized patients with advanced COVID-19 and lung involvement who received remdesivir recovered faster than similar patients who received placebo, according to data from a randomized, controlled trial involving 1,063 patients. The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, was the first clinical trial launched in the United States to show efficacies for remdesivir for COVID-19.
Visit ClinicalTrials.gov for additional details.
Partcipating IDCRC Sites:
- University of Alabama at Birmingham
- The Hope Clinic of the Emory VTEU
- University of Maryland School of Medicine VTEU
- Saint Louis University VTEU
- New York University
- University of Rochester Medical Center VTEU
- Vanderbilt University Medical Center VTEU
- Baylor College of Medicine VTEU and subsite University of Texas Medical Branch
- University of Washington VTEU
Adaptive COVID-19 Treatment Trial 2 (ACTT 2) - COMPLETED
ACTT 2 is a randomized, controlled clinical trial evaluating the safety and efficacy of a treatment regimen of the investigational antiviral remdesivir plus the anti-inflammatory drug baricitinib for coronavirus disease 2019 (COVID-19). National Institute of Allergy and Infectious Diseases (NIAID) is sponsoring the trial. The clinical trial is the next iteration of NIAID’s Adaptive COVID-19 Treatment Trial (ACTT).
Visit ClinicalTrials.gov for additional details.
Partcipating IDCRC Sites:
- University of Alabama at Birmingham
- The Hope Clinic of the Emory VTEU
- University of Maryland School of Medicine VTEU
- Saint Louis University VTEU
- New York University
- University of Rochester Medical Center VTEU
- Vanderbilt University Medical Center VTEU
- Baylor College of Medicine VTEU and subsite University of Texas Medical Branch