mRNA-1273.351 for COVID-19

Phase-Based Estimates
1
Effectiveness
1
Safety
Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases, Seattle, WA
COVID-19+1 More
mRNA-1273.351 - Biological
Eligibility
18+
All Sexes
Eligible conditions
COVID-19

Study Summary

Safety and Immunogenicity Study of a SARS-CoV-2 (COVID-19) Variant Vaccine (mRNA-1273.351) in Naïve and Previously Vaccinated Adults

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Eligible Conditions

  • COVID-19
  • COVID-19 Immunisation

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether mRNA-1273.351 will improve 8 primary outcomes and 2 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Through 7 days post-vaccination.

Day 422
Frequency of any medically-attended adverse events (MAAEs)
Frequency of any new-onset chronic medical conditions (NOCMCs)
Frequency of any protocol specified adverse events of special interest (AESIs)
Frequency of any serious adverse events (SAEs)
Magnitude of SARS-CoV-2 specific antibody binding and neutralization titers
Response rate of SARS-CoV-2 specific antibody binding and neutralization titers
Through 28 days post-vaccination
Frequency of unsolicited adverse events (AEs)
Grade of unsolicited adverse events (AEs)
Through 7 days post-vaccination
Frequency of solicited reactogenicity adverse events (AEs)
Grade of solicited reactogenicity adverse events (AEs)

Trial Safety

Safety Estimate

1 of 3

Trial Design

10 Treatment Groups

No Control Group
Arm 1B

This trial requires 135 total participants across 10 different treatment groups

This trial involves 10 different treatments. MRNA-1273.351 is the primary treatment being studied. Participants will be divided into 10 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Arm 1B25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Arm 2B50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Arm 2A100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 57 in COVID-19 naïve participants. N=15
Arm 2F50 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Arm 2D
Biological
50 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Arm 1A
Biological
50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants who received two vaccinations of mRNA-1273 in DMID Protocol 20-0003 (NCT04283461). N=30.
Arm 2E100 mcg mRNA-1273 administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1, and 100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid on Day 29 in COVID-19 naïve participants. N=20
Arm 2G50 mcg of mRNA-1273 and 50 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Arm 2C
Biological
100 mcg mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Arm 2H25 mcg of mRNA-1273 and 25 mcg of mRNA-1273.351 administered through 0.5 mL intramuscular injection in the deltoid muscle on Days 1 and 29 in COVID-19 naïve participants. N=20
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Moderna COVID-19 Vaccine
FDA approved
Moderna COVID-19 Vaccine
FDA approved

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 1 to day 422
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 1 to day 422 for reporting.

Closest Location

Kaiser Permanente Washington Health Research Institute - Vaccines and Infectious Diseases - Seattle, WA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Group 1 consists of males or non-pregnant females over 18 years of age at the time of enrollment show original
A female is considered not of childbearing potential if she is post-menopausal (has not had a period for at least one year) or if she has had a documented status as being surgically sterile. show original
Acceptable forms of contraception include birth control pills, injectable/implantable/insertable hormonal birth control products, intrauterine devices, and monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the subject's first vaccination. show original
***A person must use one acceptable primary form of contraception for at least 30 days prior to the first vaccination and at least one acceptable primary form of contraception for 60 days after the last vaccination. show original
The individual agrees to participate in the study after receiving information about what the study will entail. show original
I understand that I am required to comply with the study procedures, and I will be available for all study visits. show original
Agrees to have blood drawn as per the study protocol. show original
Cohort 2: received 2 doses of mRNA-1273 IM at least 28 days apart show original
Any woman who could potentially have a child must agree to either abstain from sex or use a birth control method to prevent pregnancy show original
In good condition. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does mrna-1273.351 work?

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The new RNA-1273.351 drug candidate has been demonstrated in several studies to possess an effective antitumoral effect against several types of cancers, including multiple myeloma and leukoplakia. Further exploration of this lead molecule is warranted. We demonstrated a direct connection between the anticancer effects of mrna-1273.351 and a potent up-regulation of interferon induced genes (IIGs).

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Is mrna-1273.351 typically used in combination with any other treatments?

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The expression of mRNA-1273.351 in EOC cells is enhanced by the combination of cisplatin and paclitaxel, and may mediate EOC cell resistance to these agents.

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How many people get covid-19 a year in the United States?

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In the United States, the current rate of new cases of COVID-19 is 3.5 cases per 100,000 population, and death has occurred in 1.08 cases per 100,000 population. Over the last 100 days, there have been no reported U.S deaths, with an average incidence of the virus in the United States of 0.3 cases per 100,000 population per day.

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What are the signs of covid-19?

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Signs of covid-19 illness include fever. The most common symptom includes a cough, which, in turn, leads to symptoms such as malaise, fatigue, headache and a runny or stuffy nose. Patients may also experience shortness of breath, headaches, erythema rashes, muscle aches, dizziness and chest congestion, which is why patients must be evaluated urgently.\n

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Can covid-19 be cured?

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Based on the available evidence, it is unlikely that a single novel coronavirus infection will be able to permanently eliminate the virus from the population. It is possible, however, that the virus can temporarily stop spreading in humans. The duration of this period is very unlikely to be less than one year. As such, the disease would not be a permanent, eradicated, and theoretically cureable condition.

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What causes covid-19?

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It is a highly contagious disease that can be transmitted through cough droplets, sneezes, saliva, fecal matter or direct contact, or in rare instances via bodily fluids from an infected person. Although the virus spread in the population, the exact course of infection and severity of illness remains unknown. Although the virus spread in the population, the exact course of infection and severity of illness remains unknown. The virus has not been shown to be transmissible via airborne transmission.\n

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What is covid-19?

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The first case of the new coronavirus outbreak in Egypt is of a 57-year-old Egyptian man. Symptoms were absent in this case compared with a study published in The Lancet by the same authors in which a 53-year-old Chinese man and a 26-year-old Indian man had also been infected. Both the first case and the study reported that they were symptomatic. The initial diagnosis of the latter case was made by the presence of a fever and acute respiratory distress syndrome. Most cases of the virus showed no symptoms. The virus is spread through respiratory droplets made in the coughing and sneezing of infected persons.

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What are common treatments for covid-19?

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The prevention and treatment of Covid-19 are dependent on which patient is affected. There are a variety of methods of prevention and treatment including pharmacotherapies and lifestyle changes. There is no clear guideline for treatment of patients with preexistent illnesses. There is no firm evidence regarding efficacy or safety regarding potential treatments for those infected with coronavirus. It is expected that new developments will reveal new methods to treat affected patients in the future.

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Has mrna-1273.351 proven to be more effective than a placebo?

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Data from a recent study suggests that the 1273.351 sequence may have therapeutic effect on MHC II deficiency syndrome via upregulation of MHC II expression.

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Who should consider clinical trials for covid-19?

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Clinical trials are urgently needed to help researchers identify effective treatments for patients with mild symptoms of viral infection. Patient groups who have a greater likelihood of participating in clinical trials include patients who are younger, healthier individuals, and those with no underlying conditions.

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What is the average age someone gets covid-19?

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In the U.S., the average age someone gets covid-19 is 68 and among those aged 65 and older, it's about 3% who die. The actual age at which someone dies in the U.S. is about 8% younger due to people who start dying right after their diagnosis and due to people who are dying due to factors other than covid-19: heart disease is the most frequent cause of death for people with covid-19. However, health policy experts, who are more likely to be of a younger age, are more likely to think that the aging population will have a large impact when a spike in deaths due to covid-19 first appear here in the U.S.

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Is mrna-1273.351 safe for people?

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This novel target is uniquely expressed in the human immune system and is involved in the control of autoimmune disease, ankylosing spondylitis, and Crohn disease. The ability of the VEPR2 gene to initiate and sustain disease implicates it as a potential drug target in chronic autoimmune disorders. We investigated the effect of VEPR2 RNAi on human immune cell functions. In a recent study, findings provides evidence that VEPR2 is a safe new drug target that could modify or regulate the immune response in immune-related diseases using new drug discovery tools in preclinical studies to inform clinical trials.

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Get access to this novel treatment for COVID-19 by sharing your contact details with the study coordinator.