mRNA Vaccine for COVID-19

Recruiting at 5 trial locations

Overseen By Moderna WeCare Team

Age: Any Age

Sex: Any

Trial Phase: Phase 4

Sponsor: ModernaTX, Inc.

Must not be taking: Immunosuppressants, Immunoglobulins

Disqualifiers: Recent COVID-19, Anaphylaxis, 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

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

764 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of a new mRNA COVID-19 vaccine against both known and emerging variants of the virus. Participants will receive a shot of the mRNA-1273 Variant-containing Formulation to assess their immune response. Individuals who have already been vaccinated and may be at risk for severe COVID-19 could be suitable candidates. Interested participants should not have had a recent COVID-19 infection or received a vaccine shot too close to the trial's start. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective vaccine benefits a broader range of patients.

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.

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 is the safety track record for the mRNA-1273 variant-containing formulation?

Previous studies have shown that the mRNA-1273 vaccine, also known as Spikevax, is safe for people. Research indicates that this vaccine is generally well-tolerated, with most experiencing only mild side effects, such as sore arms or slight fevers, which resolve on their own. Serious side effects are rare. The vaccine's widespread use has generated extensive safety data, providing reassurance.

It is important to note that the mRNA-1273 vaccine is already approved for use in other COVID-19 vaccines, which adds confidence in its safety. While the new versions in this trial include variations of the original vaccine, they rely on the same proven technology. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the mRNA-1273 variant-containing formulation because it offers a tailored approach to COVID-19 protection by incorporating new mRNA sequences designed to target emerging virus variants. Unlike existing vaccines that were developed based on the original strain of the virus, this treatment aims to provide broader and potentially more effective immunity against variants like mRNA-1273.167, mRNA-1273.712, and mRNA-1273.251. This adaptability may help enhance vaccine effectiveness and keep up with the virus's evolution, offering a significant advantage in controlling the pandemic.

What is the effectiveness track record for the mRNA-1273 variant-containing formulation against COVID-19?

Research has shown that the mRNA-1273 vaccine, also known as Spikevax, is highly effective at preventing COVID-19, achieving a 94.1% success rate in preventing illness, including severe cases. This vaccine has been widely used and has proven effective in real-world settings, not just in laboratories. In this trial, participants will receive an intramuscular injection of a variant-containing formulation of mRNA-1273 (mRNA-1273.167, mRNA-1273.712, or mRNA-1273.251) to test its effectiveness against new COVID-19 variants. The goal is to ensure it continues to protect people as the virus evolves. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for adults who've already had an mRNA COVID-19 vaccine and can follow the study rules. They must not be pregnant, have a negative pregnancy test before getting the shot, and use birth control or abstain from sex that could lead to pregnancy from 28 days before until 28 days after vaccination.

Inclusion Criteria

Able to comply with study procedures based on the assessment of the Investigator

I have received an mRNA COVID-19 vaccine.

I am not pregnant, have been using birth control, and agree to continue for 28 days after getting the vaccine.

Exclusion Criteria

I haven't received any blood products or immunoglobulins in the last 3 months.

I had COVID-19 within the last 3 months.

I have not been seriously ill or had a fever in the last 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an intramuscular (IM) injection of a mRNA-1273 variant-containing formulation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for immunogenicity and safety after receiving the vaccine

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1273 Variant-containing Formulation

Trial Overview The study tests new versions of the mRNA-1273 vaccine designed to fight different COVID-19 variants. It checks how well these updated vaccines work against both known and emerging variants in people who've been vaccinated before.

How Is the Trial Designed?

Group I: mRNA-1273 Variant-containing Formulation Experimental Treatment 1 Intervention

Participants will receive an intramuscular (IM) injection of a mRNA-1273 variant-containing formulation (mRNA-1273.167, mRNA-1273.712, or mRNA-1273.251).

mRNA-1273 Variant-containing Formulation is already approved in European Union, United States, Canada, Switzerland, United Kingdom for the following indications:

Approved in European Union as Spikevax for:

• Prevention of COVID-19

Approved in United States as Spikevax for:

• Prevention of COVID-19

Approved in Canada as Spikevax for:

• Prevention of COVID-19

Approved in Switzerland as Spikevax for:

• Prevention of COVID-19

Approved in United Kingdom as Spikevax for:

• Prevention of COVID-19

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 booster dose of the mRNA-1273 COVID-19 vaccine significantly increased neutralizing antibody levels against the original virus and key variants of concern, indicating enhanced immune response after waning immunity from the initial two-dose series.

Both the mRNA-1273 booster and variant-modified boosters were found to be safe and well-tolerated, suggesting they could be effective options for improving protection against emerging SARS-CoV-2 variants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Choi, A., Koch, M., Wu, K., et al.[2021]

The Moderna COVID-19 Vaccine (mRNA-1273) was developed using a proprietary mRNA platform and demonstrated high efficacy in preventing COVID-19 during clinical trials involving over 30,000 adults, starting with human studies in March 2020.

The vaccine received Emergency Use Authorization in December 2020 and full FDA approval in January 2022, indicating its safety and effectiveness based on interim and final analyses of trial data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Moderna COVID-19 Vaccine (mRNA-1273). Leav, B., Straus, W., White, P., et al.[2023]

A booster dose of the mRNA vaccines BNT162b2 and mRNA-1273 significantly increases the durability of antibodies against SARS-CoV-2, providing enhanced long-term protection compared to the initial two-dose series.

Antibody levels after the mRNA-1273 booster were found to be higher than those after the BNT162b2 booster, indicating that the Moderna vaccine may offer superior antibody responses in the months following the booster.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced SARS-CoV-2 IgG durability following COVID-19 mRNA booster vaccination and comparison of BNT162b2 with mRNA-1273. Ailsworth, SM., Keshavarz, B., Richards, NE., et al.[2023]

In a study involving over 4 million participants, local and systemic reactions to the mRNA COVID-19 vaccines (BNT162b2 and mRNA-1273) were commonly reported, particularly after the second dose, with 72.9% experiencing injection-site reactions and 69.5% reporting systemic reactions after dose 2.

Younger individuals (under 45 years), females, and those receiving the mRNA-1273 vaccine reported higher rates of reactogenicity, but new or worsening symptoms were rare in the second week after vaccination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reactogenicity within 2 weeks after mRNA COVID-19 vaccines: Findings from the CDC v-safe surveillance system. Chapin-Bardales, J., Myers, T., Gee, J., et al.[2022]

In a study of 4,870,915 patients receiving the Moderna mRNA-1273 vaccine, approximately 85% completed their second dose on time, indicating strong adherence to vaccination recommendations.

However, only 51% of immunocompromised patients received the recommended third dose, highlighting a gap in vaccine completion that may require targeted interventions based on demographics and community characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with receipt of mRNA-1273 vaccine at a United States national retail pharmacy during the COVID-19 pandemic. Roberts-McCarthy, E., Buck, PO., Smith-Ray, RL., et al.[2023]

The Moderna COVID-19 vaccine (mRNA-1273) was granted Emergency Use Authorization in December 2020 and has since been administered in approximately 204 million doses in the U.S., demonstrating its widespread use and acceptance as a primary vaccination method against COVID-19.

Following extensive review of clinical trial data and real-world effectiveness studies, the CDC concluded that the benefits of the Moderna vaccine in preventing COVID-19 infections and related hospitalizations significantly outweigh the associated risks, leading to its full approval for adults aged 18 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Advisory Committee on Immunization Practices' Recommendation for Use of Moderna COVID-19 Vaccine in Adults Aged ≥18 Years and Considerations for Extended Intervals for Administration of Primary Series Doses of mRNA COVID-19 Vaccines - United States, February 2022. Wallace, M., Moulia, D., Blain, AE., et al.[2022]

The Moderna COVID-19 vaccine (mRNA-1273) has been found to have a favorable safety profile, with common adverse events like injection site pain, fatigue, and headache being transient and not significant enough to discourage vaccination.

However, there is a noted increased risk of myocarditis and pericarditis in young males aged 18-29, highlighting the need for ongoing monitoring and larger studies to fully understand rare adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety outcomes associated with the moderna COVID-19 vaccine (mRNA-1273): a literature review. Shabu, A., Nishtala, PS.[2023]

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]

This report describes a rare case of delayed inflammatory myositis occurring after the third dose of the mRNA-1273 vaccine, marking the first documented instance of this specific adverse reaction following a booster shot.

The condition was confirmed through biopsy and successfully treated, highlighting the importance of monitoring for unusual side effects even after vaccination, especially with booster doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Successful Treatment of Delayed Localized Necrotizing Inflammatory Myositis After Severe Acute Respiratory Syndrome Coronavirus 2 mRNA-1273 Vaccine: A Case Report. Li, JC., Siglin, J., Marshall, MS., et al.[2023]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2035389

Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9117141/

Effectiveness of mRNA-1273 against SARS-CoV-2 ... Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: interim results from a prospective observational cohort study. Lancet Reg. Health Am.6 ...

3. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/spikevax

Spikevax (previously COVID-19 Vaccine Moderna) Spikevax is a vaccine for preventing coronavirus disease 2019 (COVID-19) in people from the age of 6 months.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04470427

NCT04470427 | A Study to Evaluate Efficacy, Safety, and ... The study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19 for up to 2 years after the second dose ...

5. thelancet.com thelancet.com/journals/laninf/article/PIIS1473-3099(25)00236-1/fulltext

Efficacy, immunogenicity, and safety of a next-generation ... We evaluated the relative vaccine efficacy (rVE), immunogenicity, and safety of mRNA-1283 compared to the first-generation vaccine (mRNA-1273).

6. fda.gov fda.gov/media/155675/download

Package Insert - SPIKEVAX Analyses of postmarketing data from use of authorized or approved mRNA COVID-19 vaccines, including SPIKEVAX, have demonstrated increased risks ...

7. gha.gi gha.gi/wp-content/uploads/2023/01/Moderna-mRNA1273-SARS-CoV2-vaccine-SDS-PIL.pdf

Safety Data Sheet The mRNA in SARS-CoV2 vaccine is not viral or pathogenic and does not require specific biosafety handling recommendations. As an mRNA molecule with a large ...