*nih.life
			Clinical Trial Sponsors: National Institute of Allergy and Infectious Diseases (NIAID)

  Source:		NCT04283461


    		Safety and Immunogenicity Study of 2019-nCoV
     		Vaccine (mRNA-1273) for Prophylaxis
			SARS CoV-2 Infection (COVID-19)

			Recruiting

			First Update February 21, 2020
			Last Update April 9, 2020

			Brief Summary
			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.

			Detailed Description
			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
			(25 microgram [mcg], 100 mcg, 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. The secondary objective is to
			evaluate the immunogenicity as measured by
			Immunoglobulin G (IgG) enzyme-linked
			immunosorbent assay ELISA to the SARS-CoV-2
			S (spike) protein following a 2-dose vaccination
			schedule of mRNA-1273 at Day 57.

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