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mRNA-1273Wiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (2)

Name (Synonyms) Correlation
drug604 Peginterferon Lambda-1a Wiki 1.00
drug616 Placebo Wiki 0.10

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D014777 Virus Diseases NIH 0.11
D007239 Infection NIH 0.08
D045169 Severe Acute Respiratory Syndrome NIH 0.07
D018352 Coronavirus Infections NIH 0.06

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

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, 18 to 55 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 one domestic site. Forty-five subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of mRNA-1273 on Days 1 and 29 in the deltoid muscle. Subjects will be followed through 12 months post second vaccination (Day 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 3 dosages in healthy adults.

NCT04283461 Corona Virus Infection Immunisations Biological: mRNA-1273
MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

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

No related HPO nodes (Using clinical trials)