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Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

Our take —

This trial will evaluate the safety of a 2-dose vaccination schedule of mRNA-1273 for COVID-19. The study has three treatment groups, with 15 healthy adults in each group (total of 45 study subjects). Each treatment group will receive two vaccinations, spaced 28 days apart, but the dose of the vaccine will be different in each of the three groups. No placebo group was included, which is a limitation. The study will follow up with participants regularly to determine if they have any side effects, and will also investigate the immune response elicited by the vaccine 57 days after the second dose.

Study design

Non-Randomized Trial

Study population and setting

This is a phase I, open-label, dose ranging clinical trial in males and non-pregnant females, 18 to 55 years of age, 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 has begun at sites in Georgia and Washington and started enrolling patients on March 3, 2020.

Fifteen subjects will be included in each of three escalating dosage groups: 25 microgram [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).

Summary of Main Findings

N/A, study is incomplete

Study Strengths

N/A, study is incomplete

Limitations

N/A, study is incomplete

Value added

This study will help in assessing the safety of the mRNA vaccine and also measure the seroconversion in individuals in a dose dependent manner.