COVID-19 Variant Immunologic Landscape Trial (COVAIL Trial)

• ClinicalTrials.gov Identifier: NCT05289037
• Recruitment Status: Active, not recruiting
• First Posted: March 21, 2022
• Last Update Posted: June 9, 2023
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Information provided by (Responsible Party): National Institute of Allergy and Infectious Diseases (NIAID)

Study Description

Brief Summary:

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. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) >/ = 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination.

Condition or disease	Intervention/treatment	Phase
COVID-19	Drug: AS03; Biological: BNT162b2; Biological: BNT162b2 (B.1.1.529); Biological: BNT162b2 (B.1.351); Biological: BNT162b2 bivalent (wildtype and Omicron BA.1); Biological: BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5); Biological: CoV2 preS dTM [B.1.351]; Biological: CoV2 preS dTM/D614; Biological: CoV2 preS dTM/D614+B.1.351; Biological: mRNA-1273; Biological: mRNA-1273.351; Biological: mRNA-1273.529; Biological: mRNA-1273.617.2; Other: Sodium Chloride, 0.9%	Phase 1; Phase 2

Detailed Description:

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. A randomized open-label, non-placebo controlled, multi-site, multi-stage clinical trial in individuals, 18 years of age and older, who are in a stable state of health, has received a complete authorized/approved vaccine series (primary series + booster either with homologous or heterologous vaccine products) >/= 16 weeks prior to enrollment. Subjects will be stratified by i) age (18-64 years and = 65 years of age) (however arms 16 and 17 or stage 4 will only enroll participants between the ages of 18-49 years) and ii) history of confirmed prior SARS-CoV-2 infection, and randomly assigned to receive one of several variant vaccines. Enrollment will target a goal of approximately 45% of each of the variant vaccine arms to be in older adults (= 65 years of age) for stages 1, 2 and 3 and approximately 20% to have had confirmed COVID-19 for all 4 stages. This is an adaptive design and may add arms of new vaccine platforms and/or variant lineage spike vaccines as needed. The study arms will be conducted in different stages (that could overlap) depending on public health needs and the availability of study products (starting with the available mRNA vaccines). The primary objective is to evaluate humoral immune responses of candidate SARS-CoV-2 variant vaccines, alone or in combination. The secondary objective is to evaluate the safety of candidate SARS-CoV-2 variant vaccines, as assessed by: a) Local and systemic solicited Adverse Events for 7 days following each vaccine dose; b) Unsolicited Adverse Events from Dose 1 to 28 days following each vaccine dose; c) Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interests (AESIs), New Onset of Chronic Medical (NOCMCs) and Adverse Events (AEs) leading to withdrawal from the study from Dose 1 to 12 months after last vaccine dose.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1270 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Phase 2 Clinical Trial to Optimize Immune Coverage of SARS-CoV-2 Existing and Emerging Variants
• Actual Study Start Date: March 30, 2022
• Estimated Primary Completion Date: March 28, 2026
• Estimated Study Completion Date: March 28, 2026

Arms and Interventions

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	Biological: mRNA-1273; Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).; Other: Sodium Chloride, 0.9%; 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	Biological: mRNA-1273.351; 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.; Biological: mRNA-1273.529; 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.; Other: Sodium Chloride, 0.9%; 0.9% Sodium Chloride Injection
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	Biological: mRNA-1273.351; 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.; Biological: mRNA-1273.529; 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.; Other: Sodium Chloride, 0.9%; 0.9% Sodium Chloride Injection
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	Biological: mRNA-1273.529; 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.; Biological: mRNA-1273.617.2; 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.; Other: Sodium Chloride, 0.9%; 0.9% Sodium Chloride Injection
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	Biological: mRNA-1273.529; 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.; Other: Sodium Chloride, 0.9%; 0.9% Sodium Chloride Injection
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	Biological: mRNA-1273; Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike (S) protein of the 2019 novel coronavirus (2019-nCoV).; Biological: mRNA-1273.529; 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.; Other: Sodium Chloride, 0.9%; 0.9% Sodium Chloride Injection
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	Biological: BNT162b2; 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	Biological: BNT162b2 (B.1.1.529); 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.; Biological: BNT162b2 (B.1.351); 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	Biological: BNT162b2 (B.1.1.529); 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	Biological: BNT162b2 (B.1.351); 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	Biological: BNT162b2; A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.; Biological: BNT162b2 (B.1.351); 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	Biological: BNT162b2; A nucleoside-modified messenger RNA (modRNA) encoding the viral spike glycoprotein (S) of SARS-CoV-2.; Biological: BNT162b2 (B.1.1.529); 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	Drug: AS03; AS03 oil-in-water emulsion adjuvant.; Biological: CoV2 preS dTM/D614; 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	Drug: AS03; AS03 oil-in-water emulsion adjuvant.; Biological: CoV2 preS dTM [B.1.351]; 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	Drug: AS03; AS03 oil-in-water emulsion adjuvant.; Biological: CoV2 preS dTM/D614+B.1.351; 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	Biological: BNT162b2 bivalent (wildtype and Omicron BA.1); 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	Biological: BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5); 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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.
3. 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.

Secondary Outcome Measures :

1. Adverse Events (AEs) leading to withdrawal from the study [ Time Frame: Day 1 through Day 366 ]
2. Incidence of Adverse Events of Special Interest (AESI) [ Time Frame: Day 1 through Day 366 ]
3. Incidence of Medically Attended Adverse Events (MAAEs) [ Time Frame: Day 1 through Day 366 ]
4. Incidence of New Onset Chronic Medical Conditions (NOCMCs) [ Time Frame: Day 1 through Day 366 ]
5. Incidence of Serious Adverse Events (SAE) [ Time Frame: Day 1 through Day 366 ]
6. Incidence of Solicited Adverse Events [ Time Frame: Day 1 through Day 8 ]
   Local and systemic events
7. Incidence of Unsolicited Adverse Events [ Time Frame: Day 1 through Day 29 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be eligible to participate in this study:

1. Individuals > / = 18 years of age at the time of consent. (18-49 years for stage 4).
2. 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.
3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.
4. 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:

1. Confirmed SARS-CoV-2 infection < 16 weeks prior to any study vaccine dose.
2. Pregnant and breastfeeding participants.

3. 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.

4. Current/planned simultaneous participation in another interventional study or receipt of any investigational study product within 28 days prior to vaccine study dose(s).
5. 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.
6. A history of myocarditis or pericarditis at any time prior to enrollment (for subjects in stages 1, 2 and 4).

7. 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.

8. 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.
9. Current or previous diagnosis of an immunocompromising condition or other immunosuppressive condition.
10. Advanced liver or kidney diseases.
11. Advanced (CD4 count < 200) and/or untreated HIV, untreated Hepatitis B or untreated Hepatitis C.

12. 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.

13. Received immunoglobulin or blood-derived products, within 3 months prior any study vaccine dose.
14. Received chemotherapy, immunotherapy or radiation therapy within 6 months prior to any study vaccine dose.
15. Study personnel or an immediate family member or household member of study personnel.

16. 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.

17. Plan to receive a COVID-19 booster vaccine outside of the study within the next 180 days. (for subjects in Stage 4 only)

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham School of Medicine - Alabama Vaccine Research Clinic

Birmingham, Alabama, United States, 35294

United States, California

University of California, San Diego (UCSD) - Antiviral Research Center (AVRC)

San Diego, California, United States, 92103-8208

Zuckerberg San Francisco General Hospital, UCSF Positive Health Program

San Francisco, California, United States, 94110-2859

United States, District of Columbia

George Washington University Medical Faculty Associates

Washington, District of Columbia, United States, 20037-3201

Howard University - Department of Medicine - Division of Infectious Disease

Washington, District of Columbia, United States, 20060

United States, Georgia

Morehouse School of Medicine - Clinical Research Center

Atlanta, Georgia, United States, 30310

Emory University School of Medicine

Atlanta, Georgia, United States, 30322-1013

The Hope Clinic of Emory University

Decatur, Georgia, United States, 30030-1705

United States, Illinois

University of Illinois at Chicago College of Medicine - Division of Infectious Diseases

Chicago, Illinois, United States, 60612

United States, Iowa

University of Iowa Hospitals & Clinics - Department of Internal Medicine

Iowa City, Iowa, United States, 52242

United States, Louisiana

Tulane University Clinical Translational Unit

New Orleans, Louisiana, United States, 70112

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115-6110

United States, Missouri

Saint Louis University Center for Vaccine Development

Saint Louis, Missouri, United States, 63104-1015

Washington University School of Medicine in St. Louis - Infectious Disease Clinical Research Unit

Saint Louis, Missouri, United States, 63110

United States, New York

NYU Grossman School, NYU Langone Vaccine Center, Long Island

Mineola, New York, United States, 11501

NYU Langone Vaccine Center Research Clinic, Manhattan

New York, New York, United States, 10016

University of Rochester Medical Center - Vaccine Research Unit

Rochester, New York, United States, 14611-3201

United States, North Carolina

Duke Vaccine and Trials Unit

Durham, North Carolina, United States, 27703

United States, Texas

Baylor College of Medicine

Houston, Texas, United States, 77030-3411

University of Texas Medical Branch

League City, Texas, United States, 77573

United States, Washington

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, United States, 98101

The University of Washington - Virology Research Clinic

Seattle, Washington, United States, 98104

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

  Study Documents (Full-Text)

Documents provided by National Institute of Allergy and Infectious Diseases (NIAID):

Informed Consent Form  [PDF] May 31, 2022

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Branche AR, Rouphael NG, Diemert DJ, Falsey AR, Losada C, Baden LR, Frey SE, Whitaker JA, Little SJ, Anderson EJ, Walter EB, Novak RM, Rupp R, Jackson LA, Babu TM, Kottkamp AC, Luetkemeyer AF, Immergluck LC, Presti RM, Backer M, Winokur PL, Mahgoub SM, Goepfert PA, Fusco DN, Malkin E, Bethony JM, Walsh EE, Graciaa DS, Samaha H, Sherman AC, Walsh SR, Abate G, Oikonomopoulou Z, El Sahly HM, Martin TCS, Rostad CA, Smith MJ, Ladner BG, Porterfield L, Dunstan M, Wald A, Davis T, Atmar RL, Mulligan MJ, Lyke KE, Posavad CM, Meagher MA, Stephens DS, Neuzil KM, Abebe K, Hill H, Albert J, Lewis TC, Giebeig LA, Eaton A, Netzl A, Wilks SH, Tureli S, Makhene M, Crandon S, Lee M, Nayak SU, Montefiori DC, Makowski M, Smith DJ, Roberts PC, Beigel JH; COVAIL Study Group. SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses. medRxiv. 2022 Jul 15:2022.07.12.22277336. doi: 10.1101/2022.07.12.22277336. Preprint.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT05289037
• Other Study ID Numbers: 22-0004; 75N93021D00021
• First Posted: March 21, 2022
• Last Update Posted: June 9, 2023
• Last Verified: October 3, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Adaptive; COVAIL; Covid-19; Multivalent; Omicron; SARS-CoV-2; Vaccine; Variants

Additional relevant MeSH terms:

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases