mRNA Vaccines Comparison for COVID-19 Prevention

(NextCOVE Trial)

Recruiting at 259 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immune-modifying drugs

Disqualifiers: Substance abuse, Acute illness, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 30

Duration: 1 day

14246 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new COVID-19 vaccine called mRNA-1283.222. It aims to see if this new vaccine is safe and effective. The vaccine works by using a small piece of genetic material 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 or immune-modifying drugs, you may not be eligible to participate.

What data supports the effectiveness of the treatment mRNA-1273.222 and mRNA-1283.222 for COVID-19 prevention?

The mRNA-1273 vaccine, which is similar to mRNA-1273.222, has shown high effectiveness in preventing COVID-19, with studies reporting around 94% efficacy. This suggests that mRNA-1273.222, being a related treatment, may also be effective in preventing COVID-19. ^{1 2 3 4 5}

Is the mRNA-1273 and mRNA-1283 COVID-19 vaccine generally safe for humans?

The mRNA-1273 and mRNA-1283 vaccines have been studied in various trials and are generally considered safe for humans. Most people experience mild to moderate side effects like sore arms or tiredness, and no serious safety concerns have been identified in these studies. ^{2 3 6 7 8}

How does the mRNA-1273.222 and mRNA-1283.222 treatment for COVID-19 differ from other treatments?

The mRNA-1273.222 and mRNA-1283.222 treatments are unique because they are mRNA-based vaccines that use lipid nanoparticles to deliver genetic instructions for making the spike protein of the virus, which helps the body recognize and fight the virus. This approach is different from traditional vaccines that often use weakened or inactivated viruses. ^{1 2 3 9 10}

Eligibility Criteria

This trial is for people ≥12 years old who've had a full initial COVID-19 vaccination series, and if they're ≥18, at least one booster. They must show proof of vaccination, be able to follow the study plan, and not be pregnant or become pregnant during the study. People can't join if they've been exposed to COVID-19 recently, are sick or have a fever before starting the trial, have conditions that could risk their health in the study or affect results, plan to get other vaccines close to this trial's timeline, received certain treatments like blood products or immunosuppressants near the start of the trial.

Inclusion Criteria

For female participants 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 the first injection, and agreement to continue adequate contraception or abstinence through 90 days following the vaccine administration.

I understand and can follow the study's requirements.

I have completed the initial COVID-19 vaccine series and, if over 18, received a booster.

Exclusion Criteria

I have not received any blood products or immunoglobulins in the last 90 days and do not plan to receive any during the study.

I have not taken strong immune system drugs for more than 2 weeks in the last 6 months.

I have not had, nor plan to have, any vaccines 60 days before or after the study injection.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of either mRNA-1283 or mRNA-1273 on Day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, immunogenicity, and vaccine efficacy

365 days

Multiple visits (in-person and virtual) on Days 29, 91, 181, and 365

Treatment Details

Interventions

• mRNA-1273.222
• mRNA-1283.222

Trial Overview The study compares two mRNA vaccines: mRNA-1283.222 (new) versus mRNA-1273.222 (existing). It looks at how safe they are and how bodies react to them ('reactogenicity'), as well as comparing their effectiveness ('relative vaccine efficacy') and immune response ('immunogenicity').

Participant Groups

Group I: Part 2: mRNA-1283.815 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1283.815 on Day 1.

Group II: Part 2: mRNA-1273.815 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1273.815 on Day 1.

Group III: Part 1: mRNA-1283.222 Experimental Treatment 1 Intervention

Participants will receive single intramuscular (IM) injection of mRNA-1283.222 on Day 1.

Group IV: Part 1: mRNA-1273.222 Experimental Treatment 1 Intervention

Participants will receive single IM injection of mRNA-1273.222 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

Findings from Research

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]

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 Covid-19 vaccine was found to be safe for children aged 6 months to 5 years, with mostly low-grade and transient adverse events, and no new safety concerns identified during the trial.

The vaccine elicited immune responses in young children that were comparable to those in young adults, meeting noninferiority criteria, with estimated efficacy rates of 36.8% for children aged 2-5 years and 50.6% for those aged 6-23 months against Covid-19.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. Anderson, EJ., Creech, CB., Berthaud, V., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: Interim results from a prospective observational cohort study. [2022]

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

Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase. [2023]

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

In high-risk adults, the Moderna vaccine had 94% efficacy against COVID-19 ≥14 d after the 2nd dose. [2021]

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

Humoral Immunogenicity of the mRNA-1273 Vaccine in the Phase 3 Coronavirus Efficacy (COVE) Trial. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Variant SARS-CoV-2 mRNA vaccines confer broad neutralization as primary or booster series in mice. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Reactogenicity to the mRNA-1273 Booster According to Previous mRNA COVID-19 Vaccination. [2022]

7. 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]

8. 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]

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

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. [2023]

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

Evaluation of mRNA-1273 Vaccine in Children 6 Months to 5 Years of Age. [2023]