Studies


Phase 1, Placebo-Controlled, Double-Blinded Study to Assess the Safety and Pharmacokinetics of Single Ascending Doses of EV68-228-N in Healthy Adult Volunteers

This is a Phase 1, randomized, placebo-controlled, double-blinded study to assess the safety and pharmacokinetics of single intravenous (IV) administrations of EV68-228-N in healthy adult volunteers. The study will enroll 3 cohorts that will be dosed sequentially with a single dose at increasing dose levels. All participants will be monitored for adverse events (AE) following dosing and safety laboratory data through Day 8. This data will be reviewed by a Safety Monitoring Committee (SMC) before advancing to the next cohort.The dosing of each cohort will begin with a sentinel pair of 1 active and 1 placebo recipient. There will be a minimum of 2 days of observation of the sentinels before the PI authorizes dosing of additional participants in each cohort. The study population will be comprised of generally healthy males and non-pregnant, non-lactating females, aged 18-49 years inclusive at the time of first vaccination, regardless of religion, sex, or ethnic background, who meet all the inclusion and none of the exclusion criteria. Subjects will be recruited from the general population of the participating Vaccine and Treatment Evaluation Unit (VTEU) sites.

Participating IDCRC Sites:

  • Vanderbilt University
  • The University of Maryland, Baltimore

A Study of Doxycycline to Treat Chlamydial Infection

This is a Phase 4 blinded, randomized, active-controlled, non-inferiority trial. Persons of any gender identity will be eligible. Final evaluable population will include a minimum 596 individuals: 298 persons assigned female sex at birth (AFAB) with confirmed urogenital chlamydia (CT) and 298 persons assigned male at birth (AMAB) with confirmed rectal chlamydia (CT). Approximately 664 participants will be enrolled to achieve a minimum 596 participants who contribute primary outcome data. Randomization will be stratified by study site and sex at birth: 332 persons assigned female sex at birth (AFAB) and 332 persons assigned male sex at birth (AMAB). Participants will be randomized 1:1 to a 3-day regimen of doxycycline or a 7-day regimen of doxycycline. The study blind will be maintained by providing 7 days of identical pre-filled blister packs, one with 3 days of active treatment and 4 days of placebo, and the other with 7 days of active treatment. Participants will be asked to return 28 days after randomization (at day 29), at which time they will be re-tested for chlamydia (CT) using a laboratory-based chlamydia (CT) nucleic acid amplification test (NAAT).

Participating IDCRC Sites:

  • University of Washington: Harborview Medical Center (Seattle, WA), Ganjoni Clinic (Mombasa, Kenya), KEMRI-CCR (Thika, Kenya)
  • Emory University: Grady Memorial Hospital (Atlanta, GA) and Emory University Hospital Midtown (Atlanta, GA)
  • University of Rochester Medical Center (Rochester, NY)

Visit ClinicalTrials.gov and search identifier NCT05840159 for additional details.

Pharmacokinetic Study of IV Artesunate to Treat Children With Severe Malaria

This clinical study is a phase 4, single-site, open-label pharmacokinetic (PK) study of IV artesunate in up to 100 Ugandan children 6 months-14 years of age who are diagnosed with severe malaria according to standardized World Health Organization (WHO) criteria (any P. falciparum parasitemia and the presence of danger signs). Participants will receive the standard of care IV artesunate for initial treatment of severe malaria per WHO guidelines: children weighing <20 kg should receive 3.0 mg/kg/dose compared to children weighing =20 kg who should receive 2.4 mg/kg/dose, at times 0, 12, 24, 48 and 72 hours (WHO 2015). Parenteral treatment will be administered for a minimum of 24 hours (irrespective of the patient's ability to tolerate oral medication earlier), after which patients will be evaluated clinically and assessed for ability for oral intake of antimalarials. Children who are able to transition to oral antimalarial therapy will initiate a 3-day course of artemisinin-combination oral therapy per national guidelines. The primary objective of the study is to determine the relationship between DHA exposures following IV artesunate dosing and markers of physiologic dysfunction associated with severe malaria in Ugandan children.

Participating IDCRC Sites:

  • University of Maryland (Makerere University Infectious Disease Institute-Uganda)

Visit ClinicalTrials.gov and search identifier NCT05750459 for additional details.

Trial to Evaluate the Immunogenicity of Dose Reduction Strategies of the MVA-BN Monkeypox Vaccine

This study is a Phase 2 randomized, open-label, non-placebo controlled, multi-site clinical trial that will evaluate two intradermal (ID) regimens for Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine compared to the standard subcutaneous (SC) regimen in healthy, vaccinia-naïve adults 18 to 50 years of age, inclusive. At least 210 participants will be enrolled and randomized to one of three study arms. The two dose sparing strategies include one-fifth (2 x 10^7) and one-tenth (1 x 10^7) of the standard dose of MVA-BN administered ID on Day 1 and 29 (Arm 1 and 2, respectively). The comparator arm (Arm 3) will be the 2-dose standard (1 x 10^8) MVA-BN SC regimen. 

Participating IDCRC Sites:

  • Emory Vaccine Center - The Hope Clinic
  • Saint Louis University - Center for Vaccine Development
  • Vanderbilt University Medical Center - Infectious Diseases
  • Baylor College of Medicine - Molecular Virology and Microbiology

Visit ClinicalTrials.gov and search identifier NCT05512949 for additional details.

Safety and Immunogenicity of CJCV2 With and Without ALFQ

This is a randomized, double-blind, dose-escalating, outpatient trial in a total of approximately 60 subjects, assigned to 3 cohorts (20 subjects per cohort). Each subject will receive one of three intramuscular (IM) vaccinations, spaced 28 days apart, of Campylobacter jejuni Conjugate Vaccine (CJCV2) with or without a fixed dose of the adjuvant Army Liposome Formulation containing QS-21 (ALFQ)(200 mcg 3D-PHAD, 100 mcg QS-21). Three doses (1 ug, 3 ug and 10 ug) of CJCV2 will be evaluated. The first six participants at each dose will be sentinels and randomized in a 1:1 blinded fashion to receive CJCV2 with or without ALFQ. The primary objective is to evaluate the safety of the three different doses of IM injection of CJCV2 with and without ALFQ. The study hypothesis is that the CJCV2 vaccine alone and CJCV2 with ALFQ adjuvant will be safe and that the CJCV2 alone will be immunogenic, with immunogenicity enhanced through the use of the adjuvant ALFQ.

Participating IDCRC Site:

  • Cincinnati Children’s Hospital Medical Center VTEU

Visit ClinicalTrials.gov and search identifier NCT05500417 for additional details.

Safety, Tolerability, and Immunogenicity Study of Sm-p80 + GLA-SE (SchistoShield(R)) Vaccine in Healthy Adults (DMID 18-0018)

This phase 1 trial will assess the safety of the Sm-p80 + GLA-SE (SchistoShield®) study vaccine. The research will measure indicators of immunity to Schistosomiasis. The study will also assess whether the vaccine prompts an immune response, leading to the generation of antibodies that can prevent infection. Participants will include healthy people ages 18 through 55 years old. Volunteers will be assigned to one of five study groups, based on when they enroll in the study. Each group will include nine participants. Group A will receive the study vaccine without the adjuvant (a substance that increases the body’s response to vaccines), at a dose of 100 micrograms (μg) of Sm-p80, to test whether the adjuvant acts to increase immune responses. Groups B, C, D and E will receive the study vaccine with adjuvant. The dose of the Sm-p80 protein will be 10 μg in Group B, 30 μg in Groups C and D, and 100 μg in Group E to find out what dose leads to the best immune responses and side effect profile. The study will run over a 15-month period.

Participating IDCRC Site:

  • Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases (UM1AI148576)

Visit ClinicalTrials.gov and search identifier NCT05292391 for additional details.

COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial) (22-004)

This phase 2 clinical trial will evaluate the safety and immunogenicity of additional doses of prototype and variant (alone or in combination) vaccine candidates in previously vaccinated participants with or without prior severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and will evaluate innate, cellular, and humoral immune responses to inform on how to shift the immune response to cover new variants as they emerge. Subjects will include individuals 18 years of age and older who are in a stable state of health and have received a complete authorized/approved vaccine series (primary series and booster either with homologous or heterologous vaccine products) 16 weeks prior to enrollment. Subjects will be stratified by age and history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. 

Visit ClinicalTrials.gov and search identifier NCT05289037 for additional details.

Participating IDCRC Sites:

  • Emory Children's Center - Pediatric Infectious Diseases
  • Emory Vaccine Center - The Hope Clinic
  • University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
  • Saint Louis University - Center for Vaccine Development
  • Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
  • NYU Grossman School, NYU Langone Vaccine Center, Long Island site
  • NYU Langone Vaccine Center Research Clinic, Manhattan site
  • University of Rochester Medical Center - Vaccine Research Unit
  • Baylor College of Medicine - Molecular Virology and Microbiology
  • University of Texas Medical Branch - Division of Infectious Disease
  • Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases
  • The University of Washington - Virology Research Clinic

Meningococcal Serogroup ACYWX Conjugate Vaccine in Comparison With MenACWY-TT Conjugate Vaccine (DMID 20-0024)

Meningococcal meningitis, caused by invasive strains of Neisseria meningitidis, is a major public health concern because of its considerable morbidity and mortality in sub-Saharan Africa. Case fatality during meningococcal meningitis epidemics can surpass 15%, and rates of permanent sequelae among meningitis survivors in Africa are twice as high as they are in high income countries. Because of the fulminant clinical course of invasive bacterial meningitis and difficulties in access to care in the African meningitis belt, prevention by vaccination is the optimal way to reduce meningococcal meningitis morbidity and mortality. Infants aged 9 months will be randomized to receive a meningococcal vaccine at 9 months or 15 months. Infants randomized to the 9-month age group will be further randomized in a 2:1 ratio to receive a single dose of the experimental meningococcal vaccine (NmCV-5) or a single dose of the comparator meningococcal vaccine (MenACWY-TT). Prospectively identified and consented infants randomized to the 15-month age group will return when aged 15 months and will be randomized in a 2:1 ratio to receive a single dose of NmCV-5 or a single dose of MenACWY-TT.

Visit ClinicalTrials.gov and search identifier NCT05093829 for additional details.

Participating IDCRC Site:

  • University of Maryland-Baltimore VTEU affiliate site in Bamako, Mali

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 U.S. 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.

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 Maryland-Baltimore 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.

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

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

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

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:

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

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:

AstraZeneca Study of AZD1222 (CoVPN 3002) - COMPLETED

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:

Novavax Study of NVX-CoV2373 (CoVPN 3004) - COMPLETED

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:

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

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) - COMPLETED

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:

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

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:

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

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

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

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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.

Read about IDCRC-VTEU Sites Supported ACTT 1-4 Studies: Contributing to Advance COVID-19 Therapeutics.

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

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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

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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

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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."