mRNA Vaccines for COVID-19

No longer recruiting at 9 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: Antivirals, Immunosuppressants

Disqualifiers: Immunodeficiency, Anaphylaxis, Influenza, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 9

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of new mRNA vaccines for COVID-19. It examines different versions, named mRNA-1010, mRNA-1010.4, and mRNA-1010.6, to assess their efficacy and the body's response. Individuals without recent close contact with someone infected with the flu and who are not currently ill may qualify for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important vaccine development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on systemic immunosuppressants, you may need to stop if you've been on them for more than 14 days in the past 180 days, or if you anticipate needing them during the study. Inhaled, nasal, and topical steroids are allowed.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mRNA-1010 is safe. One study found that a single 50-microgram dose was well-tolerated and triggered a strong immune response, indicating good safety. Earlier trials also suggest that mRNA-1010 remains a safe option.

Specific safety data for mRNA-1010.4 is unavailable, but as a Phase 2 trial, it has already passed initial safety tests, indicating it was deemed safe enough for further testing.

For mRNA-1010.6, a review found that its medium dose was well-tolerated, suggesting a good balance of safety and effectiveness.

Overall, early findings for these mRNA vaccines indicate safety for humans. Participants in early studies have generally tolerated these vaccines well, making them promising for further trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these mRNA-based vaccines for COVID-19 because they represent a cutting-edge approach that could enhance immune response and adaptability. Unlike traditional vaccines that use inactivated viruses or viral proteins, mRNA vaccines like mRNA-1010, mRNA-1010.4, and mRNA-1010.6 work by instructing the body's cells to produce a protein that triggers an immune response. This method not only allows for rapid development and production but also offers the flexibility to quickly update the vaccine as the virus mutates. Additionally, these vaccines are administered via a simple intramuscular injection, making them easy to distribute and administer compared to more complex delivery systems.

What evidence suggests that this trial's treatments could be effective for COVID-19?

Research shows that mRNA-1010 vaccines, including mRNA-1010, mRNA-1010.4, and mRNA-1010.6, hold promise in enhancing the body's defense against the flu. This trial will evaluate different versions of the mRNA-1010 vaccine. One study found that mRNA-1010 triggered strong immune responses in adults, suggesting it could effectively protect against the flu. Early reports from Moderna highlighted that mRNA-1010 performed well, with a relative vaccine efficacy (rVE) of 26.6%, indicating it worked better than some existing vaccines. While this research focuses on the flu, the mRNA technology used in these vaccines has also succeeded in COVID-19 vaccines, demonstrating its versatility and potential effectiveness. ^{2 5 6 7 8}

Are You a Good Fit for This Trial?

Healthy adults who can follow the study plan, have not had a flu shot or any vaccine within certain time frames before the trial, and show no severe allergies to mRNA vaccines. Women must test negative for pregnancy and use contraception. People with unstable health conditions or recent close contact with influenza cases are excluded.

Inclusion Criteria

Investigator has assessed that the participant understands and is willing and physically able to comply with protocol mandated follow up, including all procedures.

For assigned females at birth and of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement to continue adequate contraception through 90 days following vaccine administration.

Exclusion Criteria

Participant has received a licensed seasonal influenza vaccine within 5 months (150 days) prior to Day 1.

Participant has received any vaccine authorized or approved by local health agency ≤28 days prior to study intervention dosing (Day 1) or plans to receive a vaccine authorized or approved by local health agency within 28 days before or after study intervention dosing.

You had a severe allergic reaction after getting mRNA or influenza vaccines in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of mRNA-1010 vaccine candidate variations by intramuscular injection on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Visits on Days 8, 29, 91, and 181

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1010
• mRNA-1010.4
• mRNA-1010.6

Trial Overview

The trial is testing different versions of an mRNA-based flu vaccine called mRNA-1010 (including variations like mRNA-1010.4 and mRNA-1010.6) to see how safe they are, how people react to them, and how well they work at triggering an immune response.

How Is the Trial Designed?

Group I: mRNA-1010.6 Dose C Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group II: mRNA-1010.6 Dose B Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group III: mRNA-1010.6 Dose A Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010.6 by IM injection on Day 1.

Group IV: mRNA-1010.4 Dose C Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Group V: mRNA-1010.4 Dose B Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010.4 by IM injection on Day 1.

Group VI: mRNA-1010 Dose C Experimental Treatment 1 Intervention

Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

In a study involving over 3.3 million individuals who received COVID-19 mRNA vaccines, there was no increased risk for serious adverse events like acute myocardial infarction, immune thrombocytopenia, disseminated intravascular coagulation, Bell's Palsy, or myocarditis/pericarditis after vaccination.

The analysis showed a slight increase in the risk of pulmonary embolism after the primary series of the BNT162b2 vaccine, but this risk was not present after the booster dose, supporting the overall favorable safety profile of COVID-19 mRNA vaccines in the elderly population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of potential adverse events following COVID-19 mRNA vaccination among adults aged 65 years and older: Two self-controlled studies in the U.S. Shoaibi, A., Lloyd, PC., Wong, HL., et al.[2023]

In a study of 1842 patients who visited the emergency department within 10 days of receiving COVID-19 vaccines, the most common reasons for visits included trauma, hypertensive emergencies, and generalized pain, with a mortality rate of 2.2%.

The study found that serious adverse events (AEs) following vaccination were significantly lower than those associated with COVID-19 infections, indicating that while AEs can occur, they are less frequent and less severe compared to the risks of the virus itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of adverse events after COVID-19 vaccination. Kewan, T., Flores, M., Mushtaq, K., et al.[2022]

In a survey of 2,849 individuals aged 18-49 who completed mRNA COVID-19 vaccinations, about 90% reported adverse events (AEs), with 3.3% after the first dose and 4.3% after the second dose experiencing severe AEs.

Factors associated with a higher incidence of AEs included receiving the mRNA-1273 vaccine, being female, having dermatologic diseases, and a history of serious allergic reactions or anticoagulant medication use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. Yoon, D., Jeon, HL., Noh, Y., et al.[2023]

In a large study involving nearly 885,000 vaccinated individuals, the BNT162b2 mRNA vaccine was found to have a low risk of serious adverse events, with a notable but rare increase in myocarditis risk (2.7 events per 100,000 persons).

Compared to the risks associated with SARS-CoV-2 infection, which showed a significantly higher risk of myocarditis (11 events per 100,000 persons) and other serious conditions, the vaccine's safety profile is favorable, indicating that vaccination is safer than infection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. Barda, N., Dagan, N., Ben-Shlomo, Y., et al.[2023]

In a study of 395 healthcare workers who received the Oxford/AstraZeneca COVID-19 vaccine, 270 participants (68.4%) reported at least one adverse event, with common symptoms including muscle ache, fatigue, headache, and fever.

No serious adverse events such as hospitalization, disability, or death were reported, indicating that while mild to moderate side effects are common, the vaccine is generally safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of Oxford/AstraZeneca's COVID-19 vaccine among health care workers of Ayder Comprehensive Specialized Hospital, Tigray, Ethiopia. Tequare, MH., Abraha, HE., Adhana, MT., et al.[2022]

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