mRNA Vaccines for COVID-19

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

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing different versions of a new vaccine called mRNA-1010. It likely involves healthy volunteers or at-risk individuals. The vaccine uses mRNA to help the body recognize and fight the virus.

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 the mRNA COVID-19 vaccine generally safe for humans?

Research shows that mRNA COVID-19 vaccines have a good safety profile, but some studies have identified potential risks for certain adverse events (unwanted side effects) in older adults. These findings do not necessarily mean the vaccine causes these events, but they highlight the importance of ongoing safety monitoring. ^{1 2 3 4 5}

How is the mRNA-1010 COVID-19 vaccine different from other COVID-19 treatments?

The mRNA-1010 vaccine is unique because it uses mRNA technology to instruct cells to produce the spike protein of the virus, which helps the immune system recognize and fight the virus. This approach is different from traditional vaccines that often use weakened or inactivated viruses. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment mRNA-1010, mRNA-1010, mRNA-1010.4, mRNA-1010.6 for COVID-19?

Research on similar mRNA vaccines, like mRNA-1273, shows they can create strong immune responses that protect against COVID-19 without causing severe side effects. This suggests that mRNA-1010 and its variants might also be effective in preventing COVID-19. ^{11 12 13 14 15}

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

COVID-19 vaccine mRNA-1273 elicits a protective immune profile in mice that is not associated with vaccine-enhanced disease upon SARS-CoV-2 challenge. [2023]

2. China pubmed.ncbi.nlm.nih.gov

COVID-19 mRNA vaccines. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Effectiveness of BNT162b2 and mRNA-1273 covid-19 vaccines against symptomatic SARS-CoV-2 infection and severe covid-19 outcomes in Ontario, Canada: test negative design study. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Real world SARS-COV-2 vaccine effectiveness in a Miami academic institution. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of BNT162b2 and mRNA-1273 Second Doses and Boosters for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection and SARS-CoV-2-Related Hospitalizations: A Statewide Report From the Minnesota Electronic Health Record Consortium. [2022]

6. Netherlands 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Characteristics and outcomes of adverse events after COVID-19 vaccination. [2022]

8. Korea (South) pubmed.ncbi.nlm.nih.gov

A Nationwide Survey of mRNA COVID-19 Vaccinee's Experiences on Adverse Events and Its Associated Factors. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. [2023]

10. England 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. [2022]

11. Netherlands pubmed.ncbi.nlm.nih.gov

A phase 1/2 randomised placebo-controlled study of the COVID-19 vaccine mRNA-1273 in healthy Japanese adults: An interim report. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

Distinct antibody and memory B cell responses in SARS-CoV-2 naïve and recovered individuals following mRNA vaccination. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

Durability of Heterologous and Homologous COVID-19 Vaccine Boosts. [2023]

14. Netherlands pubmed.ncbi.nlm.nih.gov

The dawn of mRNA vaccines: The COVID-19 case. [2022]

15. England pubmed.ncbi.nlm.nih.gov

Immunogenicity and efficacy of mRNA COVID-19 vaccine MRT5500 in preclinical animal models. [2023]