- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05289037
COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)
Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants
Study Overview
Status
Conditions
Intervention / Treatment
- Biological: mRNA-1273
- Other: Sodium Chloride, 0.9%
- Biological: mRNA-1273.351
- Biological: mRNA-1273.529
- Biological: mRNA-1273.617.2
- Biological: BNT162b2
- Biological: BNT162b2 (B.1.1.529)
- Biological: BNT162b2 (B.1.351)
- Drug: AS03
- Biological: CoV2 preS dTM/D614
- Biological: CoV2 preS dTM [B.1.351]
- Biological: CoV2 preS dTM/D614+B.1.351
- Biological: BNT162b2 bivalent (wildtype and Omicron BA.1)
- Biological: BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic
-
-
California
-
San Diego, California, United States, 92103-8208
- University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)
-
San Francisco, California, United States, 94110-2859
- Zuckerberg San Francisco General Hospital, UCSF Positive Health Program
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20060
- Howard University - Department of Medicine - Division of Infectious Disease
-
Washington, District of Columbia, United States, 20037-3201
- George Washington University Medical Faculty Associates
-
-
Georgia
-
Atlanta, Georgia, United States, 30310
- Morehouse School of Medicine - Clinical Research Center
-
Atlanta, Georgia, United States, 30322-1013
- Emory University School of Medicine
-
Decatur, Georgia, United States, 30030-1705
- The Hope Clinic of Emory University
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- University of Illinois at Chicago College of Medicine - Division of Infectious Diseases
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa Hospitals & Clinics - Department of Internal Medicine
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70112
- Tulane University Clinical Translational Unit
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115-6110
- Brigham and Women's Hospital
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit
-
Saint Louis, Missouri, United States, 63104-1015
- Saint Louis University Center for Vaccine Development
-
-
New York
-
Mineola, New York, United States, 11501
- NYU Grossman School, NYU Langone Vaccine Center, Long Island
-
New York, New York, United States, 10016
- NYU Langone Vaccine Center Research Clinic, Manhattan
-
Rochester, New York, United States, 14611-3201
- University of Rochester Medical Center - Vaccine Research Unit
-
-
North Carolina
-
Durham, North Carolina, United States, 27703
- Duke Vaccine and Trials Unit
-
-
Texas
-
Houston, Texas, United States, 77030-3411
- Baylor College of Medicine
-
League City, Texas, United States, 77573
- University of Texas Medical Branch
-
-
Washington
-
Seattle, Washington, United States, 98101
- Kaiser Permanente Washington Health Research Institute
-
Seattle, Washington, United States, 98104
- The University of Washington - Virology Research Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible to participate in this study:
- Individuals > / = 18 years of age at the time of consent. (18-49 years for stage 4).
- Confirmed receipt of a complete primary and booster COVID-19 vaccine series, either homologous or heterologous, with an FDA authorized/approved vaccine at least 16 weeks prior to study vaccine dose 1.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
- Determined by medical history, targeted physical examination and clinical judgement of the investigator to be in stable state of health.
Note: Participants with pre-existing stable chronic medical conditions defined as condition not requiring significant change in therapy or hospitalization for worsening disease within 4 weeks from enrollment, can be included at the discretion of the investigator.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded from the study:
- Confirmed SARS-CoV-2 infection < 16 weeks prior to any study vaccine dose.
- Pregnant and breastfeeding participants.
Prior administration of an investigational coronavirus vaccine at any time or SARS-CoV-2 immunoglobulin, monoclonal antibody or plasma antibody therapy in the preceding 3 months.
Note: subjects that participated in clinical trials of products that are now FDA approved/authorized are allowed to participate.
- Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s).
- A history of anaphylaxis, urticaria, or other significant adverse reaction requiring medical intervention after receipt of a vaccine, polyethylene glycol (PEG), polysorbate or nanolipid particles.
- A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1, 2 and 4).
Received or plans to receive a vaccine within 28 days prior to or after any dose of study vaccine.
Note: Receipt of seasonal influenza vaccine is allowed at any time.
- Bleeding disorder diagnosed by a healthcare provider (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or bleeding difficulties with intramuscular injections or blood draws.
- Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition.
- Advanced liver or kidney diseases.
- Advanced (CD4 count < 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C.
Received oral, intramuscular or intravenous systemic immunosuppressants, or immune-modifying drugs for >14 days in total within 6 months prior to any study vaccine dose (for corticosteroids = 20 mg > / = day of prednisone equivalent).
Note: Topical medications are allowed.
- Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose.
- Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose.
- Study personnel or an immediate family member or household member of study personnel.
Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as > / = 38.0 degrees Celsius/100.4 degrees Fahrenheit). Participants meeting this criterion may be rescheduled within the relevant window periods.
Note: Afebrile participants with minor illnesses can be enrolled at the discretion of the Investigator, as long as the illness is not suggestive of COVID-19.
- Plan to receive a COVID-19 booster vaccine outside of the study within the next 180 days. (for subjects in Stage 4 only)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 01
mRNA-1273 administered through 0.2 mg/ml intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
0.9% Sodium Chloride Injection
|
Experimental: Arm 02
0.1 mg/ml of mRNA-1273.351
and 0.2 mg/ml of mRNA-1273.529
mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
0.9% Sodium Chloride Injection
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351
variant SARS-CoV-2 strain.
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 03
0.1 mg/ml of mRNA-1273.351
and 0.2 mg/ml of mRNA-1273.529
mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
0.9% Sodium Chloride Injection
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike (S) protein of the B.1.351
variant SARS-CoV-2 strain.
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 04
0.2 mg/ml of mRNA-1273.617.2 and 0.2 mg/ml of mRNA-1273.529
administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
0.9% Sodium Chloride Injection
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.617.2 (Delta) variant SARS-CoV-2 strain.
|
Experimental: Arm 05
0.2 mg/ml of mRNA-1273.529
administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
0.9% Sodium Chloride Injection
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 06
0.2 mg/ml of mRNA-1273.529
and mRNA-1273 0.2 mg/ml administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=100
|
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).
0.9% Sodium Chloride Injection
Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 07
500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.
|
Experimental: Arm 08
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351
(Beta) variant SARS-CoV-2 strain.
|
Experimental: Arm 09
500 mcg/mL of BNT162b2 (Omicron) administered through intramuscular injection in the deltoid muscle on Day 1 and Day 57 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 10
500 mcg/mL of BNT162b2 (Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351
(Beta) variant SARS-CoV-2 strain.
|
Experimental: Arm 11
500 mcg/mL of BNT162b2 (Beta) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.351
(Beta) variant SARS-CoV-2 strain.
|
Experimental: Arm 12
500 mcg/mL of BNT162b2 (Omicron) and 500 mcg/mL of BNT162b2 (Wildtype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer contains mRNA that encodes for the prefusion stabilized S protein of the B.1.1.529
(Omicron) variant SARS-CoV-2 strain.
|
Experimental: Arm 13
500 mcg/mL CoV2 preS dTM-AS03 [D614] (prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
AS03 oil-in-water emulsion adjuvant.
Is a liquid formulation made of recombinant protein placed in a formulation buffer.
The antigen solution contains the spike protein sequence of the ancestral strain of SARS-CoV-2.
|
Experimental: Arm 14
500 mcg/mL CoV2 preS dTM-AS03 [B.1.351]
(Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
AS03 oil-in-water emulsion adjuvant.
Is a liquid formulation made of recombinant protein placed in a formulation buffer that contains the spike protein sequence of the B.1.351
(Beta) variant SARS-CoV-2 strain.
|
Experimental: Arm 15
500 mcg/mL CoV2 preS dTM-AS03 [D614 + B.1.351]
(prototype + Beta) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 64; > / = 65 years (~45% in > / = 65 years) N=50
|
AS03 oil-in-water emulsion adjuvant.
Is a liquid formulation made of recombinant protein placed in a formulation buffer contains the spike protein sequences of the ancestral and B.1.351
(Beta) variant SARS-CoV-2 strains
|
Experimental: Arm 16
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.1) + Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100
|
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer.
Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.1 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.
|
Experimental: Arm 17
100 mcg/mL BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)
+ Wildtype (Prototype) administered through intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 49 years; ( 45% in > / = 49 years) N=100
|
A preservative-free, sterile dispersion of RNA formulated in LNP in aqueous cryoprotectant buffer.
Contains mRNA that encodes for the prefusion stabilized S protein of the Omicron BA.4/BA.5 variant SARS-CoV-2 strain and the ancestral strain of SARS-CoV-2.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in Geometric Mean Fold Rise (GMFR)
Time Frame: Day 1 through Day 366
|
As measured by Immunoglobin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) or Multiplex Meso Scale Discovery (MSD) antibody binding assays to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) proteins.
Neutralization titers will be calculated by neutralization assays using SARS-CoV-2 variant-specific S-pseudotyped viruses and different strains of live SARS-CoV-2.
|
Day 1 through Day 366
|
Change from baseline in Geometric Mean Titers (GMT)
Time Frame: Day 1 through Day 366
|
As measured by Immunoglobin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) or Multiplex Meso Scale Discovery (MSD) antibody binding assays to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) proteins.
Neutralization titers will be calculated by neutralization assays using SARS-CoV-2 variant-specific S-pseudotyped viruses and different strains of live SARS-CoV-2.
|
Day 1 through Day 366
|
Change in Geometric Mean Ratio
Time Frame: Day 1 through Day 366
|
As measured by Immunoglobin G (IgG) Enzyme-Linked Immunosorbent Assay (ELISA) or Multiplex Meso Scale Discovery (MSD) antibody binding assays to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) proteins.
Neutralization titers will be calculated by neutralization assays using SARS-CoV-2 variant-specific S-pseudotyped viruses and different strains of live SARS-CoV-2.
|
Day 1 through Day 366
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events (AEs) leading to withdrawal from the study
Time Frame: Day 1 through Day 366
|
Day 1 through Day 366
|
|
Incidence of Adverse Events of Special Interest (AESI)
Time Frame: Day 1 through Day 366
|
Day 1 through Day 366
|
|
Incidence of Medically Attended Adverse Events (MAAEs)
Time Frame: Day 1 through Day 366
|
Day 1 through Day 366
|
|
Incidence of New Onset Chronic Medical Conditions (NOCMCs)
Time Frame: Day 1 through Day 366
|
Day 1 through Day 366
|
|
Incidence of Serious Adverse Events (SAE)
Time Frame: Day 1 through Day 366
|
Day 1 through Day 366
|
|
Incidence of Solicited Adverse Events
Time Frame: Day 1 through Day 8
|
Local and systemic events
|
Day 1 through Day 8
|
Incidence of Unsolicited Adverse Events
Time Frame: Day 1 through Day 29
|
Day 1 through Day 29
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0004
- 75N93021D00021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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