Modified mRNA Vaccines for Infectious Diseases

Recruiting at 7 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Corticosteroids, others

Disqualifiers: Recent vaccines, Allergies, others

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

Compensation: Varies

Number of Visits: 3

Duration: 24 weeks

308 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{6 8 11 12 13}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Part 2: mRNA-1273 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1273 on Day 1

Group II: Part 2: mRNA-1010 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1010 on Day 1.

Group III: Part 1: mRNA-1647 3-Dose Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1647 on Days 1, 57, and 169.

Group IV: Part 1: mRNA-1647 2-Dose Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1647 on Days 1 and 57.

Group V: Part 1: mRNA-1345 Experimental Treatment 1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1345 on Day 1.

Group VI: Part 2: FLUAD® Active Control 1 Intervention

Participants will receive single IM injection of FLUAD® 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

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

The mRNA-1273 Moderna COVID-19 vaccine was found to have a safety profile in a real-world setting in Japan that is consistent with clinical trial data, indicating it is well-tolerated among participants.

In a survey of 301 respondents, 98% reported local and systemic adverse events following the second dose, with younger individuals (18-29 years) and females experiencing higher rates of adverse events after the first dose, although these differences diminished with subsequent doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University. Okumura, K., Hara, A., Inada, I., et al.[2022]

Citations

1. Germany pubmed.ncbi.nlm.nih.gov

Self-amplifying mRNA-Based Vaccine Technology and Its Mode of Action. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Protective Immune Responses Induced by an mRNA-LNP Vaccine Encoding prM-E Proteins against Japanese Encephalitis Virus Infection. [2023]

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

Revolutionizing viral disease vaccination: the promising clinical advancements of non-replicating mRNA vaccines. [2023]

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

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]

5. China pubmed.ncbi.nlm.nih.gov

[mRNA vaccines for infectious diseases: research progress and applications]. [2023]

6. Iran pubmed.ncbi.nlm.nih.gov

Safety and Adverse Events Related to COVID-19 mRNA Vaccines; a Systematic Review. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Analysis of the adverse events following the mRNA-1273 COVID-19 vaccine. [2023]

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

Comparative safety of mRNA COVID-19 vaccines to influenza vaccines: A pharmacovigilance analysis using WHO international database. [2022]

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

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]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time Survey of Vaccine Safety of the mRNA-1273 SARS-CoV-2 Vaccine in Workplace Vaccination at Keio University. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

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]

12. England pubmed.ncbi.nlm.nih.gov

Adaptation to cell culture induces functional differences in measles virus proteins. [2019]

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

Modified mRNA-LNP Vaccines Confer Protection against Experimental DENV-2 Infection in Mice. [2020]