|drug317||Convalescent anti-SARS-CoV-2 plasma Wiki||1.00|
|drug799||Oral placebo Wiki||1.00|
|drug584||Injective placebo Wiki||1.00|
|D011024||Pneumonia, Viral NIH||0.14|
|D045169||Severe Acute Respiratory Syndrome NIH||0.06|
|D018352||Coronavirus Infections NIH||0.05|
There is one clinical trial.
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.
Description: Seroconversion is defined as a 4-fold change in antibody titer from baselineMeasure: Percentage of subjects who seroconverted Time: Day 1 to Day 57