Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04927065
Recruitment Status : Active, not recruiting
First Posted : June 15, 2021
Last Update Posted : May 2, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Brief 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, and mRNA-1273.214.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Biological: mRNA-1273.211 Biological: mRNA-1273 Biological: mRNA-1273.617.2 Biological: mRNA-1273.213 Biological: mRNA-1273.529 Biological: mRNA-1273.214 Phase 2 Phase 3

Detailed Description:

This clinical study will consist of 7 parts: A, B, C, D, E, F, and G.

Part A 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 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 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).

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4658 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants
Actual Study Start Date : May 28, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Experimental: Part A: mRNA-1273.211 50 μg
Participants will receive 1 intramuscular booster dose of 50 micrograms (μg) of mRNA-1273.211 on Day 1.
Biological: mRNA-1273.211
Sterile liquid for injection

Experimental: Part A: mRNA-1273.211 100 μg
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.211 on Day 1.
Biological: mRNA-1273.211
Sterile liquid for injection

Experimental: Part B: mRNA-1273 100 μg
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273 on Day 1.
Biological: mRNA-1273
Sterile liquid for injection

Experimental: Part C: mRNA-1273.617.2 100 μg
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.617.2 on Day 1.
Biological: mRNA-1273.617.2
Sterile liquid for injection

Experimental: Part C: mRNA-1273.617.2 50 μg
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.617.2 on Day 1.
Biological: mRNA-1273.617.2
Sterile liquid for injection

Experimental: Part D: mRNA-1273.213 50 μg
Participants will receive 1 intramuscular booster dose of 50 μg of mRNA-1273.213 on Day 1.
Biological: mRNA-1273.213
Sterile liquid for injection

Experimental: Part D: mRNA-1273.213 100 μg
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Biological: mRNA-1273.213
Sterile liquid for injection

Experimental: Part E: mRNA-1273.213 100 μg
Participants will receive 1 intramuscular booster dose of 100 μg of mRNA-1273.213 on Day 1.
Biological: mRNA-1273.213
Sterile liquid for injection

Experimental: Part F Cohort 1: mRNA-1273.529 50 μg
Participants will receive 1 intramuscular first booster dose of 50 μg of mRNA-1273.529 on Day 1.
Biological: mRNA-1273.529
Sterile liquid for injection

Experimental: Part F Cohort 2: mRNA-1273.529 50 μg and mRNA-1273 50 μg
Participants will receive 1 intramuscular second booster dose of 50 μg of mRNA-1273.529 (after receiving a primary series of mRNA-1273 and a single booster dose of mRNA-1273 50 μg) on Day 1.
Biological: mRNA-1273
Sterile liquid for injection

Biological: mRNA-1273.529
Sterile liquid for injection

Experimental: Part G: mRNA-1273.214 50 μg
Participants will receive 1 intramuscular second booster dose of mRNA-1273.214 50 μg on Day 1.
Biological: mRNA-1273.214
Sterile liquid for injection




Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody at Day 29 [ Time Frame: Day 29 ]
  2. GMT of SARS-CoV-2-Specific Antibody at Day 91 (For Part G only) [ Time Frame: Day 91 ]
  3. GMT of Omicron-Specific Antibody (For Parts F and G only) at Day 29 [ Time Frame: Day 29 ]
  4. GMT of Omicron-Specific Antibody at Day 91 (For Part G only) [ Time Frame: Day 91 ]
  5. Seroresponse Rate of Vaccine Recipients at Day 29 [ Time Frame: Day 29 ]
  6. Seroresponse Rate of Vaccine Recipients at Day 91 (For Part G only) [ Time Frame: Day 91 ]
  7. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [ Time Frame: Up to Day 7 (7 days post-vaccination) ]
  8. Number of Participants with Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 28 (28 days post-vaccination) ]
  9. Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs) [ Time Frame: Up to Day 366 ]

Secondary Outcome Measures :
  1. GMT of SARS-CoV-2-Specific Antibody [ Time Frame: Days 1, 15, 181, and 366 ]
  2. GMT of Omicron-Specific Antibody (For Parts F and G only) [ Time Frame: Days 1, 15, 181, and 366 ]
  3. Seroresponse Rate of Vaccine Recipients [ Time Frame: Days 1, 15, 181, and 366 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927065


Locations
Show Show 23 study locations
Sponsors and Collaborators
ModernaTX, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04927065    
Other Study ID Numbers: mRNA-1273-P205
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1273
mRNA-1273 vaccine
mRNA-1273.211
mRNA-1273.617.2
mRNA-1273.213
mRNA-1273.529
mRNA-1273.214
SARS-CoV-2
SARS-CoV-2 Vaccine
Coronavirus
Virus Diseases
Messenger RNA
COVID 19
COVID 19 Vaccine
Moderna