NCT04927065

A Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 (COVID-19) Variants

A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 5,161 (actual)
• Sponsor: ModernaTX, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.211, mRNA-1273, mRNA-1273.617.2, mRNA-1273.213, mRNA-1273.529, mRNA-1273.214, mRNA-1273.222, mRNA-1273.815, and mRNA-1273.231 administered as booster doses.

Detailed description

This clinical study will consist of 9 parts: A (1 and 2), B, C, D, E, F, G, H, and J. Part A.1 will evaluate 2 dose levels of the mRNA-1273.211 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE \[NCT04470427\]) study who have previously received 2 doses of mRNA-1273. Part A.2 will evaluate the immunogenicity, safety, and reactogenicity of the mRNA-1273.214 vaccine candidate when administered as a second booster dose to adult participants of the mRNA-1273-P205 study who have previously received 2 doses of mRNA-1273 as a primary series and a first booster of (50 μg total mRNA content) of the mRNA-1273.211 in Part A.1 of this study. Part B will evaluate the mRNA-1273 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE \[NCT04470427\]) study who have previously received 2 doses of mRNA-1273. Part C will evaluate 2 dose levels of the mRNA-1273.617.2 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE \[NCT04470427\]) study who have previously received 2 doses of mRNA-1273. Part D will evaluate 2 dose levels of the mRNA-1273.213 vaccine when administered as a single booster dose to adult participants of the mRNA-1273-P301 (COVE \[NCT04470427\]) study who have previously received 2 doses of mRNA-1273. Part E will be enrolled at a single clinical study site. Part E will evaluate the mRNA-1273.213 vaccine when administered as a single booster dose to adult participants who have previously received 2 doses of any SARS-CoV-2 mRNA authorized vaccine, including mRNA-1273. Part F will consist of 2 cohorts: Cohort 1 will consist of adults who have previously received 2 doses of mRNA-1273 as primary series. Cohort 1 will evaluate the mRNA-1273.529 vaccine as a single booster dose. Cohort 2 will consist of adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273 in study mRNA-1273-P301 (COVE \[NCT04470427\]) or under the emergency use authorization (EUA). Cohort 2 will evaluate the mRNA-1273.529 and mRNA-1273 vaccines as a single booster dose. Part G will evaluate the mRNA1273.214 vaccine candidate when administered as a second booster dose to adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273. Part H will evaluate the immunogenicity, safety, and reactogenicity of the mRNA- 1273.222 vaccine candidate when administered as a second booster dose to adults who have previously received 2 doses of mRNA-1273 as a primary series and a single booster dose of mRNA-1273. Part J will evaluate mRNA-1273.815 and mRNA-1273.231 when administered as a booster dose to adults who previously received a primary series of mRNA vaccine, a first booster dose of a monovalent mRNA vaccine, and a second booster dose of a bivalent mRNA vaccine against SARS-COV-2.

Conditions

• SARS-CoV-2

Interventions

Type	Name	Description
BIOLOGICAL	mRNA-1273.211	Sterile liquid for injection
BIOLOGICAL	mRNA-1273	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.617.2	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.213	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.529	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.214	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.222	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.815	Sterile liquid for injection
BIOLOGICAL	mRNA-1273.231	Sterile liquid for injection

Timeline

• Start date: 2021-05-28
• Primary completion: 2023-11-17
• Completion: 2023-11-17
• First posted: 2021-06-15
• Last updated: 2025-02-28
• Results posted: 2025-02-28

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study