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

SARS-CoV-2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04927065
• Other study ID #: mRNA-1273-P205
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 28, 2021
• Est. completion date: November 17, 2023

Study information

• Verified date: December 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5404
• Est. completion date: November 17, 2023
• Est. primary completion date: November 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria:

• For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, agreement to continue adequate contraception or abstinence through 3 months following the vaccination, and not currently breastfeeding.

• Participants must have been either previously enrolled in the mRNA-1273-P301 (COVE) study, must have received 2 doses of mRNA-1273 in that study, with their second dose at least 6 months prior to enrollment in this study (mRNA-1273-P205), and must be currently enrolled and compliant in that study (that is, has not withdrawn or discontinued early); or participant must have received 2 doses of mRNA-1273 under the EUA with their second dose at least 6 months prior to enrollment in mRNA-1273-P205; or have received a 2 dose primary series of mRNA-1273 followed by a 50 µg booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA at least 3 months prior to enrolment in mRNA-1273-P205; and able to provide proof of vaccination status at the time of screening (Day 1); or for enrollment in Part A.2, participant must be currently enrolled and compliant in Part A.1 of the mRNA 1273 P205 study and must have received their first booster dose of mRNA 1273.211 50 µg; or for enrollment in Part J, participant must meet at least 1 of the following criteria: completed enrollment in Part H of the mRNA-1273-P205 study; or received a 2-dose primary series of mRNA-1273 (100 µg) followed by a 50 µg booster dose of mRNA-1273 in the mRNA-1273-P301 (COVE) study or under EUA, followed by a 50 µg booster dose of mRNA-1273.222 under EUA at least 3 months prior to enrollment in Part J of mRNA-1273-P205; or previously received a 2-dose primary series of mRNA vaccine against SARS-CoV-2 followed by a booster dose of a monovalent mRNA vaccine, followed by a second booster dose of a bivalent mRNA vaccine. Participants in Part J must also provide proof of vaccination status at the time of screening (Day 0 or Day 1).

Key Exclusion Criteria:

• Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14 days, as defined by the US Centers for Disease Control and Prevention (CDC) as a close contact of someone who has had COVID-19.

• Known history of SARS-CoV-2 infection within 3 months prior to enrollment.

• Is acutely ill or febrile (temperature =38.0°Celsius/[100.4°Fahrenheit]) less than 72 hours prior to or at the Screening Visit (Day 0) or Day 1.

• Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.

• Has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids =10 milligrams (mg)/day of prednisone equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.

• Known or suspected allergy or history of anaphylaxis, urticaria, or other significant AR to the vaccine or its excipients.

• Has a documented history of myocarditis or pericarditis within 2 months prior to Screening Visit (Day 0).

• Has received or plans to receive any licensed vaccine =28 days prior to the injection (Day 1) or a licensed vaccine within 28 days before or after they study injection, with the exception of influenza vaccines, which may be given 14 days before or after receipt of a study vaccine.

• Has received systemic immunoglobulins or blood products within 3 months prior to the Screening Visit (Day 0) or plans for receipt during the study.

• Has donated =450 milliliters (mL) of blood products within 28 days prior to the Screening Visit (Day 0) or plans to donate blood products during the study.

• Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of screening for this study.

Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• mRNA-1273.211
Sterile liquid for injection
• mRNA-1273
Sterile liquid for injection
• mRNA-1273.617.2
Sterile liquid for injection
• mRNA-1273.213
Sterile liquid for injection
• mRNA-1273.529
Sterile liquid for injection
• mRNA-1273.214
Sterile liquid for injection
• mRNA-1273.222
Sterile liquid for injection
• mRNA-1273.815
Sterile liquid for injection
• mRNA-1273.231
Sterile liquid for injection

Locations

Country	Name	City	State
United States	Benchmark Research - Austin - HyperCore	Austin	Texas
United States	Tekton Research, Inc.	Austin	Texas
United States	Meridian Clinical Research-(Baton Rouge, Louisiana)	Baton Rouge	Louisiana
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Benchmark Research - Fort Worth - HyperCore	Fort Worth	Texas
United States	Meridian Clinical Research (Grand Island, Nebraska)	Grand Island	Nebraska
United States	Research Centers of America	Hollywood	Florida
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Johnson County Clinical Trials	Lenexa	Kansas
United States	Benchmark Research	Metairie	Louisiana
United States	Meridian Clinical Research, LLC	New York	New York
United States	Meridian Clinical Research (Norfolk-Nebraska)	Norfolk	Nebraska
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research-(Omaha Nebraska)	Omaha	Nebraska
United States	Meridian Clinical Research-(Rockville Maryland)	Rockville	Maryland
United States	Benchmark Research (California)	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Washington State University	Saint Louis	Missouri
United States	Meridian Clinical Research-(Savannah Georgia)	Savannah	Georgia
United States	Meridian Clinical Research (Iowa)	Sioux City	Iowa
United States	DM Clinical Research	Tomball	Texas
United States	Trial Management Associates	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29		Day 29
Primary	GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only)		Day 91
Primary	GMT of Omicron-Specific Antibody (For Part J only) at Day 15		Day 15
Primary	GMT of Omicron-Specific Antibody (For Parts F, G, H and J only) at Day 29		Day 29
Primary	GMT of Omicron-Specific Antibody at Day 91 (For Part G only)		Day 91
Primary	Geometric mean fold rise (GMFR) of Omicron-Specific Antibody (For Part J only) at Day 15		Day 15
Primary	Seroresponse Rate of Vaccine Recipients at Day 15 (For Part J only)		Day 15
Primary	Seroresponse Rate of Vaccine Recipients at Day 29		Day 29
Primary	Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only)		Day 91
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 7 (7 days post-vaccination)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 28 (28 days post-vaccination)
Primary	Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs)		Up to Day 366
Secondary	GMT of SARS-CoV-2-Specific Antibody		Days 1, 15, 181, and 366
Secondary	Seroresponse Rate of Vaccine Recipients		Days 1, 15, 181, and 366