308 Participants Needed

Modified mRNA Vaccines for Infectious Diseases

Recruiting at 7 trial locations
MC
Overseen ByModerna Clinical Trials Support Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on immunosuppressants or immune-modifying drugs, you may not be eligible to participate. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Modified mRNA Vaccines for Infectious Diseases?

Research shows that mRNA vaccines, like those used for COVID-19, are highly effective in preventing viral infections. They work by teaching the body to recognize and fight viruses, leading to strong and lasting immune responses. This technology has been successfully used in vaccines for other diseases, suggesting it could be effective for the treatments in this trial.12345

What safety data exists for modified mRNA vaccines in humans?

Studies on mRNA vaccines, like mRNA-1273 for COVID-19, show they are generally safe in humans, with common side effects being mild, such as fatigue and chills. Some studies noted a higher risk of certain manageable heart-related issues compared to flu vaccines, but overall, mRNA vaccines have a lower risk of serious side effects.678910

How do modified mRNA vaccines for infectious diseases differ from other treatments?

Modified mRNA vaccines like mRNA-1010, mRNA-1273, mRNA-1345, and mRNA-1647 are unique because they use a piece of genetic material to instruct cells to produce a protein that triggers an immune response, mimicking a viral infection without using the live virus. This approach allows for rapid production and adaptation to emerging infectious diseases, offering a flexible and potentially more effective alternative to traditional vaccines.15111213

What is the purpose of this trial?

The main goal of this study is to evaluate the safety, reactogenicity, and immunogenicity of study vaccines.

Eligibility Criteria

Healthy adults aged 18-75 (18-50 for certain vaccines) with a BMI of 18 to 35 can join. They shouldn't plan to get other vaccines within a month of the study, have severe allergies to FLUAD's components, recent blood donations, or immunosuppressant use. Those who've had COVID-19 or flu shots recently are excluded.

Inclusion Criteria

Your body mass index (BMI) should be between 18 and 35.
Your body mass index (BMI) is between 18 and 35.

Exclusion Criteria

I had flu, RSV, or COVID-19 confirmed by a test recently.
I have not taken drugs that weaken my immune system for more than 14 days in the last 6 months.
I haven't been in a clinical study in the last 28 days and won't join another for 12 months after my last study vaccine.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intramuscular injections of mRNA vaccines or FLUAD®

24 weeks
Up to 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • FLUAD®
  • mRNA-1010
  • mRNA-1273
  • mRNA-1345
  • mRNA-1647
Trial Overview The trial is testing modified mRNA vaccines targeting Flu, COVID-19, RSV and CMV. Vaccines like mRNA-1273 and others will be evaluated for safety and immune response in participants compared against FLUAD®, an approved influenza vaccine.
Participant Groups
6Treatment groups
Experimental Treatment
Active Control
Group I: Part 2: mRNA-1273Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1273 on Day 1
Group II: Part 2: mRNA-1010Experimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1010 on Day 1.
Group III: Part 1: mRNA-1647 3-DoseExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.
Group IV: Part 1: mRNA-1647 2-DoseExperimental Treatment1 Intervention
Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.
Group V: Part 1: mRNA-1345Experimental Treatment1 Intervention
Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.
Group VI: Part 2: FLUAD®Active Control1 Intervention
Participants will receive single IM injection of FLUAD® on Day 1.

Find a Clinic Near You

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 profile image

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

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

Findings from Research

Cardiac complications, particularly myopericarditis, were the most frequently reported severe adverse events associated with mRNA COVID-19 vaccines, with systemic reactions being more common after the second dose.
Despite the higher number of reported adverse effects following the Pfizer vaccine, the review concluded that the overall benefits of mRNA vaccines in controlling the COVID-19 pandemic significantly outweigh the risks of adverse events.
Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review.SeyedAlinaghi, S., Karimi, A., Pashaei, Z., et al.[2022]
A comparative safety study involving 18,755 individuals vaccinated with mRNA COVID-19 vaccines and 27,895 individuals vaccinated with influenza vaccines found that mRNA vaccines had a different safety profile, with more systemic reactions like chills and fatigue compared to the influenza vaccine.
While mRNA COVID-19 vaccines showed a higher risk for some manageable cardiovascular issues, such as hypertensive crisis and supraventricular tachycardia, they had a lower risk of serious neurological complications compared to influenza vaccines, indicating a generally favorable safety profile for mRNA vaccines.
Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database.Kim, MS., Jung, SY., Ahn, JG., et al.[2022]
In a phase 1 clinical trial involving 104 healthy adults, the mRNA-1283 vaccine was found to be safe, with no serious adverse events reported, indicating a favorable safety profile.
All doses of the mRNA-1283 vaccine (10, 30, and 100 µg) produced strong immune responses comparable to the established mRNA-1273 vaccine, suggesting its potential effectiveness in generating immunity against SARS-CoV-2.
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults.Yassini, P., Hutchens, M., Paila, YD., et al.[2023]

References

Self-amplifying mRNA-Based Vaccine Technology and Its Mode of Action. [2023]
Protective Immune Responses Induced by an mRNA-LNP Vaccine Encoding prM-E Proteins against Japanese Encephalitis Virus Infection. [2023]
Revolutionizing viral disease vaccination: the promising clinical advancements of non-replicating mRNA vaccines. [2023]
Effectiveness of mRNA Booster Vaccination Against Mild, Moderate, and Severe COVID-19 Caused by the Omicron Variant in a Large, Population-Based, Norwegian Cohort. [2022]
[mRNA vaccines for infectious diseases: research progress and applications]. [2023]
Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. [2022]
Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine. [2023]
Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. [2022]
Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults. [2023]
Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University. [2022]
Enhancement of the HIV-1-Specific Immune Response Induced by an mRNA Vaccine through Boosting with a Poxvirus MVA Vector Expressing the Same Antigen. [2021]
Adaptation to cell culture induces functional differences in measles virus proteins. [2019]
13.United Statespubmed.ncbi.nlm.nih.gov
Modified mRNA-LNP Vaccines Confer Protection against Experimental DENV-2 Infection in Mice. [2020]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security