Modified mRNA Vaccines for Infectious Diseases

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new mRNA vaccines to evaluate their safety and effectiveness against infectious diseases. It includes various vaccine options, such as mRNA-1010, mRNA-1273, mRNA-1345, and mRNA-1647, each with distinct dosing schedules. The study aims to assess the body's response to these vaccines and any side effects. Individuals in good health without recent exposure to respiratory viruses like the flu, RSV, or COVID-19 may be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive these new 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.

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

Research has shown that the vaccines tested in this trial have been safe in previous studies.

For mRNA-1345, a vaccine for respiratory syncytial virus (RSV), studies found it was well-tolerated by adults aged 18–59, with no major safety concerns and a good immune response.

The mRNA-1647 vaccine, tested for cytomegalovirus (CMV), was generally safe and well-tolerated, with no serious side effects, and it triggered strong immune responses in participants.

The mRNA-1273 vaccine, known for its use in COVID-19 prevention, has been safe in large groups, though some rare cases of allergic reactions and heart-related issues were noted.

Lastly, mRNA-1010, aimed at influenza, showed no serious side effects in trials. Some adverse reactions occurred, but they were less frequent and less severe among adults.

Overall, these vaccines have demonstrated promising safety records in earlier studies. However, as this is an early-phase trial, it aims to gather more data on safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these mRNA vaccines because they represent a cutting-edge approach to preventing infectious diseases. Unlike traditional vaccines that typically use weakened or inactivated viruses, these mRNA vaccines, including mRNA-1010, mRNA-1273, mRNA-1345, and mRNA-1647, use synthetic messenger RNA to instruct cells to produce a protein that triggers an immune response. This method can be more efficient and faster to produce and adapt for emerging infectious threats. Additionally, the flexibility of mRNA technology allows for the development of multi-target vaccines, which could protect against multiple diseases with a single shot. These potential benefits make mRNA vaccines a promising advancement over conventional vaccine strategies.

What evidence suggests that this trial's treatments could be effective for infectious diseases?

Research shows that mRNA-1345, one of the treatments in this trial, effectively prevents lung infections caused by RSV (respiratory syncytial virus). A single dose has proven effective for several months in adults and is considered safe. Participants in this trial may receive mRNA-1345.

Another treatment option in this trial is mRNA-1647, which aims to prevent cytomegalovirus (CMV). Studies have shown mixed results, with effectiveness ranging from 6% to 50%, depending on the study. However, it has been found to be safe and has improved immune responses in previous trials. Participants may receive either a 2-dose or 3-dose regimen of mRNA-1647.

For mRNA-1273, another treatment in this trial, research indicates it offers strong protection against severe COVID-19, significantly reducing hospitalizations and symptoms. Participants may receive a single dose of mRNA-1273.

Lastly, mRNA-1010, also part of this trial, targets the seasonal flu and has shown to be safe and effective in boosting immune responses in adults, with a vaccine effectiveness of about 26.6%. Participants may receive a single dose of mRNA-1010. ^{1 2 4 6 7}

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

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970786/

An mRNA-based seasonal influenza vaccine in adults mRNA-1010 (50-µg) demonstrated an acceptable reactogenicity and safety profile among the >14,000 adult participants vaccinated in both trials.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X25001446

A phase 3 randomized safety and immunogenicity trial of ... mRNA-1010 is an mRNA-based vaccine targeting seasonal influenza A and B strains. mRNA-1010 elicited strong immune responses in adults of all ages.

3. cidrap.umn.edu cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trial

Moderna announces promising efficacy results from mRNA ... In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11793046/

Safety and Immunogenicity of mRNA-1010, an Investigational ... In conclusion, findings from this phase 1/2 study demonstrated that mRNA-1010 elicited broad and durable humoral responses that persisted through 6 months, as ...

5. healio.com healio.com/news/infectious-disease/20250702/moderna-reports-positive-phase-3-data-for-mrna-seasonal-flu-vaccine

Moderna reports positive phase 3 data for mRNA seasonal ... Positive results​​ According to results reported by Moderna, the relative vaccine efficacy (rVE) of mRNA-1010 was 26.6% (95% CI, 16.7%-35.4%) ...

6. nature.com nature.com/articles/s41467-023-39376-7

Safety and immunogenicity of a phase 1/2 randomized ... No safety concerns were identified; solicited adverse reactions were dose-dependent and more frequent after receipt of mRNA-1010 than the active ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05606965

NCT05606965 | A Study to Evaluate the Safety ... The main purpose of the study is to evaluate the safety, reactogenicity, and the humoral immunogenicity of mRNA-1010 and comparator influenza vaccines against ...