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 |
There are 2 clinical trials
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.
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 57The 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.
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)