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mRNA Vaccine
COVID-19 Vaccines for Coronavirus
Phase 2
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 366
Awards & highlights
Study Summary
This trial will study different types of vaccines for COVID-19 to see if they are safe and effective in people who have already been vaccinated. The trial will also look at the body's immune response to the vaccines to inform future vaccine development.
Who is the study for?
Adults aged 18+ in stable health who've completed their primary COVID-19 vaccination series and booster at least 16 weeks prior can join. Those with stable chronic conditions may be eligible. Excludes pregnant/breastfeeding individuals, those with advanced liver/kidney disease, recent investigational vaccine or antibody therapy recipients, and people with certain medical histories like myocarditis.Check my eligibility
What is being tested?
The COVAIL Trial is testing the safety and immune response to various prototype and variant COVID-19 vaccines (alone or combined) in adults previously vaccinated against SARS-CoV-2. It's an open-label trial where participants are randomly assigned to receive one of several variant vaccines.See study design
What are the potential side effects?
Potential side effects include typical vaccine reactions such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea; rare risks may involve allergic reactions or heart inflammation known from other mRNA vaccines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 366
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 366
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Geometric Mean Fold Rise (GMFR)
Change from baseline in Geometric Mean Titers (GMT)
Change in Geometric Mean Ratio
Secondary outcome measures
Adverse Events (AEs) leading to withdrawal from the study
Incidence of Adverse Events of Special Interest (AESI)
Incidence of Medically Attended Adverse Events (MAAEs)
+4 moreTrial Design
17Treatment groups
Experimental Treatment
Group I: Arm 17Experimental Treatment1 Intervention
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
Group II: Arm 16Experimental Treatment1 Intervention
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
Group III: Arm 15Experimental Treatment2 Interventions
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
Group IV: Arm 14Experimental Treatment2 Interventions
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
Group V: Arm 13Experimental Treatment2 Interventions
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
Group VI: Arm 12Experimental Treatment2 Interventions
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
Group VII: Arm 11Experimental Treatment2 Interventions
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
Group VIII: Arm 10Experimental Treatment2 Interventions
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
Group IX: Arm 09Experimental Treatment2 Interventions
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
Group X: Arm 08Experimental Treatment3 Interventions
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
Group XI: Arm 07Experimental Treatment1 Intervention
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
Group XII: Arm 06Experimental Treatment3 Interventions
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
Group XIII: Arm 05Experimental Treatment2 Interventions
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
Group XIV: Arm 04Experimental Treatment3 Interventions
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
Group XV: Arm 03Experimental Treatment3 Interventions
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
Group XVI: Arm 02Experimental Treatment3 Interventions
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
Group XVII: Arm 01Experimental Treatment2 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BNT162b2 (B.1.1.529)
2022
Completed Phase 2
~1270
CoV2 preS dTM/D614+B.1.351
2022
Completed Phase 2
~1270
BNT162b2 (B.1.351)
2022
Completed Phase 2
~1270
mRNA-1273
2021
Completed Phase 4
~58700
BNT162b2 bivalent (wildtype and Omicron BA.1)
2022
Completed Phase 2
~1270
mRNA-1273.617.2
2021
Completed Phase 3
~6680
CoV2 preS dTM/D614
2022
Completed Phase 2
~1270
mRNA-1273.351
2020
Completed Phase 2
~2070
BNT162b2 bivalent (wildtype and Omicron BA.4/BA.5)
2022
Completed Phase 2
~1270
CoV2 preS dTM [B.1.351]
2022
Completed Phase 2
~1270
mRNA-1273.529
2021
Completed Phase 3
~10240
BNT162b2
2021
Completed Phase 4
~91740
AS03
2017
Completed Phase 2
~5460
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,268 Previous Clinical Trials
5,479,862 Total Patients Enrolled
78 Trials studying COVID-19
290,938 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You must have completed your COVID-19 vaccination at least 16 weeks before the study starts with a vaccine approved by the FDA.You are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests and other study procedures.You are 18 years old or older when you agree to take part in the study (18-49 years old for stage 4).You have received an experimental COVID-19 vaccine or antibody treatment in the last 3 months.You have severe liver or kidney problems.You have had inflammation of the heart or the sac around the heart before joining the study.You have a diagnosed bleeding disorder or have difficulty with injections or blood draws.You have a condition that weakens your immune system.You have taken certain medications that weaken your immune system for more than two weeks in the past six months before getting the study vaccine.You have had chemotherapy, immunotherapy, or radiation therapy within 6 months before starting the study vaccine.You had a confirmed COVID-19 infection within the last 16 weeks before getting the study vaccine.You have advanced HIV with a low CD4 count, or untreated Hepatitis B or C.You have 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.You must have received all doses of an FDA-approved COVID-19 vaccine at least 16 weeks before the first dose of the study vaccine.You have had a severe allergic reaction after receiving a vaccine or specific types of ingredients like polyethylene glycol, polysorbate, or nanolipid particles.You have received both doses of an FDA-approved COVID-19 vaccine at least 16 weeks before the first dose of the study vaccine.You are at least 18 years old. If you have stage 4 cancer, you are between 18 and 49 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 11
- Group 2: Arm 02
- Group 3: Arm 07
- Group 4: Arm 10
- Group 5: Arm 05
- Group 6: Arm 08
- Group 7: Arm 16
- Group 8: Arm 04
- Group 9: Arm 14
- Group 10: Arm 17
- Group 11: Arm 06
- Group 12: Arm 09
- Group 13: Arm 12
- Group 14: Arm 13
- Group 15: Arm 15
- Group 16: Arm 01
- Group 17: Arm 03
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
COVID-19 Patient Testimony for trial: Trial Name: NCT05289037 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for enrollees in this investigation?
"As reported on clinicaltrials.gov, this particular study is not currently accepting patients due to its initial post date of March 30th 2022 and last update from November 23rd 2022. Nevertheless, there are 1,029 other medical trials at present that are recruiting candidates."
Answered by AI
What is the geographic scope of this trial's implementation?
"This experiment is taking place at Administrative Documents Site in Rockville, Maryland; Tulane University School of Medicine - Clinical Transitional Unit (CTU) in New Orleans, Louisiana; and New york University School of Medicine - Langone Medical Center - Microbiology - Parasitology in Mineola, North carolina. An additional 16 sites are also involved."
Answered by AI
Who else is applying?
What state do they live in?
Washington
Louisiana
New York
How old are they?
18 - 65
What site did they apply to?
George Washington University Medical Faculty Associates
University of Texas Medical Branch
Tulane University School of Medicine - Clinical Transitional Unit (CTU)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I like being vaccinated. I’ve had 2 covid vaccines and boosters and still contracted covid twice.
PatientReceived 2+ prior treatments
I've had previous experiences with COVID clinical trials several years ago.
PatientReceived 1 prior treatment
I was in the clinical trial for the novovax vaccine and I got the two shots and a booster of that. That trial ended and so then I had to get my other booster and I got the Pfizer booster and I had a reaction to that. I want to see if there's another vaccine like the novovax that I won't get a reaction from.
PatientReceived no prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- The University of Washington - Virology Research Clinic: < 24 hours
Average response time
- < 1 Day
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