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mRNA-1273Wiki

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (6)


Name (Synonyms) Correlation
drug2185 Saline-sodium citrate (SSC) buffer Wiki 0.71
drug1330 Lenzilumab Wiki 0.71
drug431 CELLECTRA® 2000 Wiki 0.50
drug1152 INO-4800 Wiki 0.50
drug2319 Standard of Care Wiki 0.14
drug1822 Placebo Wiki 0.04

Correlated MeSH Terms (3)


Name (Synonyms) Correlation
D018352 Coronavirus Infections NIH 0.06
D011014 Pneumonia NIH 0.04
D045169 Severe Acute Respiratory Syndrome NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.04

There are 2 clinical trials

Clinical Trials


1 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

This is a phase I, open-label, dose-ranging clinical trial in males and non-pregnant females, starting at 18 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at up to 3 domestic clinical research sites. One hundred and fifty-five subjects will be enrolled into one of thirteen cohorts (10 micrograms [mcg], 25 mcg, 50 mcg, 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliters [mL]) of mRNA-1273 on Days 1 and 29 in the deltoid muscle and will be followed through 12 months post second vaccination (Day 394). Follow-up visits will occur 1, 2, and 4 weeks post each vaccination (Days 8, 15, 29, 36, 43, and 57), as well as 3, 6, and 12 months post second vaccination (Days 119, 209, and 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 5 dosages in healthy adults.

NCT04283461 COVID-19 COVID-19 Immunisation Biological: mRNA-1273

Primary Outcomes

Measure: Frequency of solicited local reactogenicity adverse events (AEs)

Time: Through 7 days post-vaccination

Measure: Frequency of any medically-attended adverse events (MAAEs)

Time: Day 1 to Day 394

Measure: Frequency of any new-onset chronic medical conditions (NOCMCs)

Time: Day 1 to Day 394

Measure: Frequency of any serious adverse events (SAEs)

Time: Day 1 to Day 394

Measure: Frequency of any unsolicited adverse events (AEs)

Time: Through 28 days post-vaccination

Measure: Frequency of solicited systemic reactogenicity adverse events (AEs)

Time: Through 7 days post-vaccination

Measure: Grade of any unsolicited adverse events (AEs)

Time: Through 28 days post-vaccination

Measure: Grade of solicited local reactogenicity adverse events (AEs)

Time: Through 7 days post-vaccination

Measure: Grade of solicited systemic reactogenicity adverse events (AEs)

Time: Through 7 days post-vaccination

Secondary Outcomes

Measure: Geometric mean fold rise (GMFR) in IgG titer from baseline

Time: Day 1 to Day 57

Measure: Geometric mean titer (GMT) of antibody

Time: Day 57

Description: Seroconversion is defined as a 4-fold change in antibody titer from baseline

Measure: Percentage of subjects who seroconverted

Time: Day 1 to Day 57

2 A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older

The mRNA-1273 vaccine is being developed to prevent COVID-19, the disease resulting from Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) infection. 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 of mRNA-1273.

NCT04470427 SARS-CoV-2 Biological: mRNA-1273 Biological: Placebo

Primary Outcomes

Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

Measure: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal

Time: Up to Day 759 (2 years after second dose)

Measure: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)

Time: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose)

Measure: Number of Participants with Unsolicited AEs

Time: Up to Day 57 (28 days after each dose)

Secondary Outcomes

Description: Clinical signs indicative of severe COVID-19 as predefined for the study.

Measure: Number of Participants with a First Occurrence of Severe COVID-19 Starting 14 Days after Second Dose of mRNA-1273

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 Infection as predefined for the study.

Measure: Number of Participants with a First Occurrence of Either COVID-19 or SARS-CoV-2 Infection regardless of symptomatology or Severity Starting 14 Days after Second Dose of mRNA-1273 or Placebo

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)]

Description: Clinical signs indicative of secondary case definition of COVID-19 as predefined for the study.

Measure: Number of Participants with a Secondary Case Definition of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

Description: Clinical signs indicative of COVID-19 as predefined for the study.

Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after First Dose of mRNA-1273 or Placebo

Time: Day 1 (first dose) up to Day 759 (2 years after second dose)

Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

Measure: Number of Participants with a First Occurrence of COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo regardless of evidence of prior SARS-CoV-2 Infection

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

Description: Clinical signs indicative of COVID-19 and SARS-CoV-2 infection as predefined for the study.

Measure: Number of Participants with a First Occurrence of SARS-CoV-2 Infection in the Absence of Symptoms Defining COVID-19 Starting 14 days after Second Dose of mRNA-1273 or Placebo

Time: Day 29 (second dose) up to Day 759 (2 years after second dose)

Measure: Geometric Mean Titer (GMT) of SARS-CoV-2 Specific Neutralizing Antibody (nAb)

Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

Measure: Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 Specific nAb

Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

Measure: Quantified Levels or GMT of S Protein-Specific Binding Antibody (bAb)

Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759

Measure: GMFR of S Protein Specific bAb

Time: Day 1, Day 29, Day 57, Day 209, Day 394, and Day 759


No related HPO nodes (Using clinical trials)