What side effects are associated with this type of intervention?

The most common side effects of mRNA COVID-19 vaccines, such as the mRNA-CR-04 vaccine, include local reactions at the injection site (pain, redness, swelling), systemic reactions (fever, fatigue, headache, muscle pain, chills), and, less frequently, gastrointestinal symptoms (nausea). Severe allergic reactions (anaphylaxis) are rare. Other treatments for COVID-19, like tocilizumab, may cause constipation, diarrhea, nausea, anxiety, insomnia, hypertension, and superinfection. It is important to discuss these potential side effects with a healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved mRNA vaccines for COVID-19, specifically the BNT162b2 vaccine developed by Pfizer/BioNTech and the mRNA-1273 vaccine developed by Moderna. These vaccines use mRNA technology to encode the spike protein of the SARS-CoV-2 virus, thereby stimulating an immune response to protect against COVID-19. These approvals marked significant advancements in the use of mRNA technology for infectious disease prevention.

What other types of research exist?

Promising novel alternatives to the mRNA-CR-04 vaccine for COVID-19 patients in 2024 include: 1) mRNA-encoded monoclonal antibodies, which have shown efficacy and tolerability in pre-clinical studies; 2) MVA vector vaccines, which have demonstrated the ability to inhibit SARS-CoV-2 replication in animal models; and 3) Nanosecond Pulsed Electric Field (nsPEF) technology, which is being explored for its potential to improve vaccine efficacy by inactivating viruses.

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Virus Therapy

mRNA Vaccine Doses for COVID-19

Phase 1

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is a male or nonpregnant female of 18 to 49 years, inclusive, at screening

Be between 18 and 65 years old

Must not have

History of myocarditis, pericarditis, second- and third-degree heart block or idiopathic cardiomyopathy, or presence of any medical condition that increases risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis eosinophilic granulomatosis with polyangiitis, persistent myocardial viral infection (e.g., due to enterovirus or adenovirus)

Has any of the following self-reported or medically documented risk factors for severe COVID-19: Chronic kidney disease, Cerebrovascular disease, Cystic fibrosis, Chronic liver disease, Pulmonary fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to month 6

Summary

This trial is testing a new COVID-19 vaccine on healthy adults who have already been vaccinated. The goal is to see if it can safely boost their immune response. The vaccine works by using genetic material to help the body recognize and fight the virus.

Who is the study for?

Healthy adults aged 18-49 who've had their primary and booster mRNA COVID-19 vaccines at least 6 months prior can join. They must not be pregnant, plan to become pregnant soon, or have a history of severe allergies to vaccines. Participants should not have any immune system issues or serious health conditions that could affect the trial.

What is being tested?

The study tests different doses (10μg, 30μg, and 100μg) of an mRNA vaccine called mRNA-CR-04 against COVID-19 in comparison with a placebo. The goal is to assess safety and how well the body responds by producing immunity.

What are the potential side effects?

Possible side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea. These are common reactions seen with other similar vaccines but may vary based on dose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 49 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of serious heart conditions or conditions that could affect my heart.

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I have a condition like kidney disease or liver disease that increases my risk for severe COVID-19.

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I have a significant health condition like heart disease, severe asthma, or uncontrolled high blood pressure.

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I have had a fever of 100.4°F or higher in the last 3 days.

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I am not planning to become pregnant or stop using birth control within a month after getting the study vaccine.

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I haven't received and don't plan to receive any blood products or immunoglobulins 90 days before and during the study.

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I have received a non-mRNA COVID-19 vaccine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants reporting Unsolicited Adverse Events (AEs)

Number of participants reporting medically attended adverse events (MAAEs)

Number of participants with adverse events of special interest (AESIs)

+4 more

Secondary study objectives

Number of participants reporting MAAEs

Number of participants with AESIs

Number of participants with SAEs

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part B: mRNA CR-04 3 µgExperimental Treatment1 Intervention

mRNA 3 µg administered on day 1.

Group II: Part B: mRNA CR-04 10 µgExperimental Treatment1 Intervention

mRNA 10µg administered on day 1.

Group III: Part A, Group 3: mRNA CR-04 100 µg +PlaceboExperimental Treatment2 Interventions

mRNA 100µg or placebo administered on day 1.

Group IV: Part A, Group 2: mRNA CR-04 30 µg +PlaceboExperimental Treatment2 Interventions

mRNA 30µg or placebo administered on day 1.

Group V: Part A, Group 1: mRNA CR-04 10 µg +PlaceboExperimental Treatment2 Interventions

mRNA 10 micrograms (µg) or placebo administered on day 1.

Group VI: Part B: PlaceboPlacebo Group1 Intervention

Placebo administered on day 1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

mRNA vaccines, such as the mRNA-CR-04, work by encoding a viral protein, typically the spike protein of SARS-CoV-2, which is then produced by the body's cells. This stimulates the immune system to recognize and fight the virus if exposed in the future. This mechanism is crucial for COVID-19 patients as it provides a proactive defense, reducing the severity and spread of the disease. Other common treatments include antiviral drugs, which inhibit viral replication, and monoclonal antibodies, which target and neutralize the virus. These treatments are essential for managing active infections and preventing severe outcomes.

TLR4 as a therapeutic target for respiratory and neurological complications of SARS-CoV-2.AI-guided discovery of the invariant host response to viral pandemics.The race to treat COVID-19: Potential therapeutic agents for the prevention and treatment of SARS-CoV-2.