The purpose of this study is to evaluate the immunogenicity and safety of the recommended variant-containing formulations of mRNA-1283 COVID-19 vaccine (mNEXSPIKE®) within the current epidemiological environment.
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity of variant-containing formulations of the mRNA-1283 COVID-19 vaccine. As different variant-containing vaccine formulations will be evaluated, each study intervention (for example, updated mRNA-1283 COVID-19 vaccine) will be described in the subprotocol. For each evaluation of an updated variant vaccine, a new subprotocol will be generated. Subprotocol 01 is a single arm study to evaluate immunogenicity and safety of mRNA-1283 (COVID-19 vaccine) 2025-2026 formula in individuals aged ≥65 years and ≥12 to \<65 years with at least 1 underlying condition that puts them at high risk for severe outcomes from COVID-19. The study included Parts A and B. Part A enrollment was discontinued due to addition of Part B to evaluate the safety and immunogenicity of variant-containing mRNA-1283 using a hypothesis driven study endpoint with reactogenicity data collection and longer safety follow up in Part B.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
832
Sterile liquid for injection
DelRicht Research-Atlanta
Atlanta, Georgia, United States
DelRicht Research-Baton Rouge
Baton Rouge, Louisiana, United States
DelRicht Research-New Orleans
New Orleans, Louisiana, United States
DelRicht Research-Gulfport
Gulfport, Mississippi, United States
Subprotocol 1: Part A - Geometric Mean (GM) Value of Neutralizing Antibody (nAb) Against Vaccine-matched COVID-19 Variants
Time frame: Day 29
Subprotocol 1: Part A - Geometric Mean Fold Rise (GMFR) of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part B - GMFR of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part A - Seroresponse Rate (SRR) of nAb Against Vaccine-matched COVID-19 Variants
Time frame: Baseline to Day 29
Subprotocol 1: Part A - Number of Participants with Unsolicited Adverse Events (AEs), Serious Adverse Events (SAEs), AEs of Special Interests (AESIs), and AEs Leading to Study Withdrawal
Time frame: Day 1 through Day 29
Subprotocol 1: Part B - Number of Participants with Unsolicited AEs
Time frame: Day 1 through Day 29
Subprotocol 1: Part B - Number of Participants with SAEs, AESIs, and AEs Leading to Study Withdrawal
Time frame: Day 1 through Day 181
Subprotocol 1: Part B - Geometric Mean Ratio (GMR) of nAb Against Vaccine-matched COVID-19 Variants Between Participants Aged ≥12 to <65 Years and Those Aged ≥65 Years
Time frame: Day 29
Subprotocol 1: Part B - Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs)
Time frame: 7 days post vaccination
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DelRicht Research-Tulsa
Tulsa, Oklahoma, United States