Studies


Mucosal immunity against GC after 4CMenB Vaccination (DMID 19-0015)

This phase 2 double blinded study will be conducted at a single site in the US to evaluate the immune response to the meningococcal group B vaccine (4CMenB) against Neisseria gonorrhoeae (GC). The study will enroll 50 healthy young adults, ages 18-49. All study participants will have samples of mucosal secretions (body fluids/cells) collected to test for antibodies against GC and a small group of participants will also undergo rectal tissue sampling for GC.

Visit ClinicalTrials.gov and search identifier NCT04722003 for additional details.

Participating IDCRC Site:

  • Emory Vaccine Center – The Hope Clinic

Heterologous Prime Boost, Mix and Match Study (DMID 21-0012)

This clinical study will assess the use of booster doses of COVID-19 vaccines to determine the safety and effects of a booster on a person’s immunity to COVID-19. The study will include two groups: persons who have already received COVID-19 vaccines through Emergency Use Authorization (EUA), and persons who have never received a COVID-19 vaccine and have not had a prior SARS-CoV-2, the cause of COVID-19, infection. Study participants will receive a delayed booster vaccine of a COVID-19 vaccine under EUA which includes Moderna-mRNA-1273. This study will enroll approximately 400 healthy individuals ages 18 and older in the United States. The number of participants may increase with the addition of groups based on vaccines newly awarded EUA.

Read about the mixed COVID-19 vaccine booster trial on the NIH/National Institute of Allergy and Infectious Diseases (NIAID) website. 

Visit ClinicalTrials.gov and search identifier NCT04889209 for additional details.

Click here to visit the FHI 360 SharePoint site

Participating IDCRC Sites:

  • Baylor College of Medicine VTEU
  • University of Texas Medical Branch at Galveston, subsite of Baylor VTEU
  • Cincinnati Children’s Hospital Medical Center VTEU
  • Emory University VETU
  • Kaiser Permanente Washington Health Research Institute VTEU
  • University of Rochester VTEU
  • New York University VTEU
  • University of Washington VTEU
  • University of Pittsburgh, subsite of Vanderbilt VTEU
  • University of Maryland School of Medicine VTEU

SARS-CoV-2 Vaccines in Pregnancy and Postpartum, the MOMI-Vax Study (DMID 21-0004)

The NIAID-funded IDCRC is conducting an observational, non-interventional study to evaluate the safety and immune responses created by various EUA COVID-19 vaccines when administered to pregnant or postpartum individuals. The study will also assess how vaccine-induced antibodies transfer to infants through breast milk and placenta. This study will enroll approximately 750 pregnant individuals and 250 postpartum individuals who have received or will receive an authorized SARS-CoV-2 vaccine and their infants in the United States. Vaccines will not be provided through this study.

Read about the MOMI-Vax trial on the NIH/National Institute of Allergy and Infectious Diseases (NIAID) website.

Visit ClinicalTrials.gov and search identifier NCT05031468 for additional details.

Click here to visit the FHI 360 SharePoint site

Participating IDCRC Sites:

  • Baylor College of Medicine VTEU
  • University of Rochester VTEU
  • New York University VTEU
  • Emory University VTEU
  • Cincinnati Children’s Hospital Medical Center VTEU and subsite University of Cincinnati
  • UPMC Magee Women’s Hospital, subsite of University of Maryland VTEU
  • Children’s Hospital of Philadelphia, subsite of Vanderbilt VTEU
  • University of Washington VTEU and subsite Seattle Children’s Hospital
  • University of Illinois at Chicago, subsite of Saint Louis University VTEU

Moderna’s mRNA-1273 vaccine, the KidCOVE Study (mRNA-1273-P204)

Moderna is testing its mRNA-1273 COVID-19 vaccine in 3 dose levels in healthy children ages 6 months to less than 12 years. The phase 2/3 study will be conducted in two parts to evaluate the safety and effectiveness of the investigational vaccine to protect against SAVS-CoV-2, which causes COVID-19, by administering two doses of mRNA-1273 given 28 days apart. This study will enroll approximately 6,750 pediatric participants in the U.S. and Canada.

Visit ClinicalTrials.gov and search identifier NCT04796896 and http://www.kidcovestudy.com for additional details.

 Participating IDCRC Sites:

  • Vanderbilt University Medical Center VTEU
  • University of Maryland School of Medicine VTEU
  • Emory University VTEU Emory Children’s Center – Vaccine Research Center
  • Baylor College of Medicine VTEU
  • University of Rochester VTEU
  • Cincinnati Children’s Hospital Medical Center VTEU
  • Children’s Hospital of Philadelphia, subsite of Vanderbilt VTEU
  • University of Pittsburgh, subsite of Vanderbilt VTEU
  • Washington University in St. Louis, subsite of Vanderbilt VTEU

Moderna’s mRNA-1273.351 Variant vaccine (DMID 21-0002)

The mRNA-1273.351 vaccine uses the messenger RNA (mRNA)-based vaccine and encodes the S protein of the B.1.351 variant. The study will enroll individuals who have been previously vaccinated and naïve individuals who have not been vaccinated and have no history of COVID-19 disease to receive varying doses of mRNA-1273.351. The phase 1 study is being conducted in the United States to see if the variant vaccine is safe and generates an immune response. Read More

Visit ClinicalTrials.gov and search identifier NCT04785144 for additional details.

 Participating IDCRC Sites:

  • Kaiser Permanente Washington Health Research Institute VTEU
  • Emory University VTEU
  • Cincinnati Children's Hospital Medical Center VTEU
  • Vanderbilt University Medical Center VTEU

Gritstone Second Generation COVID-19 Vaccine, CORAL Program (DMID 20-0034)

Gritstone Oncology, Inc. is combining Chimpanzee Adenovirus (ChAd) and self-amplifying mRNA (SAM) vectors with SARS-CoV-2 spike protein or spike plus SARS-CoV-2 T cell epitopes to develop a second generation vaccine to prevent SARS-CoV-2, the virus that causes COVID-19, and mutant variants. The investigational vaccines will be administered in different doses of ChAd-S (or ChAd-S-TCE) and SAM-S (or SAM-S-TCE) to healthy adults as a prime vaccine and/or boost. The Gritstone phase 1 study aims to test the safety and tolerability of the investigational vaccines in the United States.

Visit ClinicalTrials.gov and search identifier NCT04776317 for additional details.

 Participating IDCRC Sites:

  • Saint Louis University VTEU
  • Emory University VTEU - The Hope Clinic
  • University of Washington VTEU
  • Baylor College of Medicine VTEU

SARS-CoV-2/COVID-19 PREVALENCE STUDY, The COMPASS Study (CoVPN 5002)

The study is designed to estimate the prevalence of SARS-CoV-2 in about 15 communities in the United States. The study will enroll approximately 60,000 people. CoVPN 5002 will evaluate the impact of COVID-19 on these communities; assess knowledge, attitude and behavior about SARS-CoV-2 and COVID-19; model the potential impact of different prevention interventions; and inform rollout of future SARS-CoV-2 prevention studies and COVID-19 treatment studies in these communities. It will also provide valuable samples for important laboratory assessments related to the acquisition of SARS-CoV-2 and impact of the COVID-19 pandemic.

Visit ClinicalTrials.gov and search identifier NCT04658121 and https://www.compassstudy.org/ for additional details.

Participating IDCRC Sites:

Novavax Study of NVX-CoV2373 (CoVPN 3004)

NVX-CoV2373 (SARS-CoV-2 rS with Matrix-M1 adjuvant) is an investigational vaccine developed by Novavax, Inc. to prevent or reduce the severity of COVID-19, the disease caused by the SARS-CoV-2 virus. The NVX-CoV2373 vaccine is made from a stabilized form of the coronavirus spike protein and contains a proprietary adjuvant, Matrix-M1. The investigational vaccine cannot replicate or cause COVID-19. The Novavax Phase 3 study aims to test the effectiveness and safety of the investigational vaccine in populations in the United States and Mexico. Read More

Visit ClinicalTrials.gov and search identifier NCT04611802 for additional details.

Participating IDCRC Sites:

The ENSEMBLE Study with Janssen’s Ad26.COV2.S Investigational Vaccine (CoVPN 3003)

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 safety and efficacy in different populations across the globe. Read More

Visit ClinicalTrials.gov and search identifier NCT04505722 for additional details.

Participating IDCRC Sites:

AstraZeneca Study of AZD1222 (CoVPN 3002)

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. Read More

Visit ClinicalTrials.gov and search identifier NCT04516746 for additional details.

Participating IDCRC Sites:

Regeneron’s 10933 and 10987 Monoclonal Antibodies, the REGN-COV2 Study (CoVPN 3502/REGN 2069)

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.

Partcipating IDCRC Sites:

  • New York University VTEU
  • Emory University VTEU Emory Children's Center - Vaccine Research Center

Eli Lilly’s LY3819253 Antibody, the BLAZE-2 Study (CoVPN 3501)

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:

Moderna’s mRNA-1273 vaccine, The COVE Study™ (CoVPN 3001)

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.

Participating IDCRC Sites:

Adaptive COVID-19 Treatment Trial 4 (ACTT 4) - COMPLETED

US map with sites named

ACTT 4 is a randomized, controlled clinical trial evaluating the safety and efficacy of two treatment regimens consisting of the antiviral remdesivir and baricitinib, a modulator of inflammation, compared to remdesivir and the corticosteroid dexamethasone in patients with coronavirus disease 2019 (COVID-19). The study is anticipated to enroll approximately 1,500 hospitalized adults with COVID-19 who require supplemental oxygen at as many as 100 sites in the United States and abroad. The trial, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), is the fourth iteration of NIAID's Adaptive COVID-19 Treatment Trial (ACTT).

Read about adaptive COVID-19 Treatment Trial 4 on the National Institute of Allergy and Infectious Diseases (NIAID) website.

Visit ClinicalTrials.gov for additional details.

Partcipating IDCRC Sites:

  • University of Alabama at Birmingham
  • Emory University VTEU
  • University of Maryland School of Medicine VTEU
  • Saint Louis University VTEU
  • New York University
  • University of Rochester Medical Center VTEU
  • Baylor College of Medicine VTEU and subsite University of Texas Medical Branch

Adaptive COVID-19 Treatment Trial 3 (ACTT 3) - COMPLETED

site map

ACTT 3 is a 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).

Read about adaptive COVID-19 Treatment Trial 3 on the National Institute of Allergy and Infectious Diseases (NIAID) website.

Visit ClinicalTrials.gov for additional details.

Partcipating IDCRC Sites:

  • University of Alabama at Birmingham
  • Emory University VTEU
  • University of Maryland School of Medicine VTEU
  • Saint Louis University VTEU
  • New York University
  • 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 University VTEU and subsite Emory Children's Center - Vaccine Research 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

US map with sites named

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. 

Read about the adaptive COVID-19 treatment trial 1 on the National Institute of Allergy and Infectious Diseases (NIAID) website.

Visit ClinicalTrials.gov for additional details.

Partcipating IDCRC Sites:

  • University of Alabama at Birmingham
  • Emory University 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

US map with sites named

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).

Read about the adaptive COVID-19 treatment trial 2 on the National Institute of Allergy and Infectious Diseases (NIAID) website.

Visit ClinicalTrials.gov for additional details.

Partcipating IDCRC Sites

  • University of Alabama at Birmingham
  • Emory University 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

Please include the following citation in any publications resulting from direct or indirect IDCRC support:

"Supported by the Infectious Diseases Clinical Research Consortium through the National Institute for Allergy and Infectious Diseases of the National Institutes of Health, under award number UM1AI148684. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health."