CovidResearchTrials by Shray Alag

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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
drug317 Convalescent anti-SARS-CoV-2 plasma Wiki 1.00
drug799 Oral placebo Wiki 1.00
drug584 Injective placebo Wiki 1.00
drug140 Baricitinib Wiki 0.50
drug1012 Sarilumab Wiki 0.41
drug505 Hydroxychloroquine Wiki 0.11

Correlated MeSH Terms (4)

Name (Synonyms) Correlation
D011024 Pneumonia, Viral NIH 0.14
D011014 Pneumonia NIH 0.07
D045169 Severe Acute Respiratory Syndrome NIH 0.06
D018352 Coronavirus Infections NIH 0.05

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 0.07

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, 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 five subjects will be enrolled into one of nine cohorts (25 micrograms [mcg], 100 mcg, and 250 mcg). Subjects will receive an intramuscular (IM) injection (0.5 milliliter [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 3 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

No related HPO nodes (Using clinical trials)