A Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 Booster Vaccine for COVID-19

NCT ID: NCT05249829

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3548 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-16
• Study Completion Date: 2023-06-23

Brief Summary

This is a 2-part study to evaluate the immunogenicity, safety, and reactogenicity of mRNA-1273.529 and mRNA-1273.214 administered as a booster dose.

Detailed Description

In Part 1, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.529 or mRNA-1273.

In Part 2, participants will be randomized in a 1:1 ratio to receive a single dose of either mRNA-1273.214 or mRNA-1273.

All participants will have previously received 2 or 3 doses of an authorized/approved COVID-19 vaccine. Participants who previously received 2 doses of a COVID-19 vaccine as a primary series will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 3rd dose, and participants who have previously received a primary series and 1 booster dose will receive mRNA-1273.529, mRNA-1273.214, or mRNA-1273 as the 4th dose (a mixed approach is acceptable). Each part will include Phase A (randomized, blinded) and Phase B (open-label, observational).

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Part 1: mRNA-1273.529

Phase A: Participants will receive 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1.

Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study.

Group Type: EXPERIMENTAL

mRNA-1273.529

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part 1: mRNA-1273

Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1.

Phase B: After Day 179, eligible participants may choose to be unblinded and to receive an additional booster outside of the study.

Group Type: ACTIVE_COMPARATOR

mRNA-1273

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part 2: mRNA-1273.214

Phase A: Participants will receive 1 IM dose of mRNA-1273.214 on Day 1.

Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study.

Group Type: EXPERIMENTAL

mRNA-1273.214

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Part 2: mRNA-1273

Phase A: Participants will receive 1 IM dose of mRNA-1273 on Day 1.

Phase B: After Day 85, eligible participants may choose to be unblinded and to receive an additional booster outside of the study.

Group Type: ACTIVE_COMPARATOR

mRNA-1273

Intervention Type: BIOLOGICAL

Sterile liquid for injection

Interventions

mRNA-1273.529

Sterile liquid for injection

Intervention Type: BIOLOGICAL

mRNA-1273

Sterile liquid for injection

Intervention Type: BIOLOGICAL

mRNA-1273.214

Sterile liquid for injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Female participants of childbearing potential may be enrolled in the study if the participant has a negative pregnancy test at the Screening Visit and on the day of vaccination prior to vaccine dose being administered on Day 1; has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1); and has agreed to continue adequate contraception through 90 days following vaccine administration.
• Participant has received 2 prior doses of one of the following approved/authorized COVID-19 vaccines: Moderna, Pfizer/BioNTech, Oxford/AstraZeneca, Janssen. A heterologous vaccine regimen is acceptable.
• Participants who will receive the 4th dose as part of the study must have previously received a mRNA vaccine (Moderna or Pfizer/BioNTech) as the 3rd dose of a COVID-19 vaccine. Participants who will receive the 3rd dose as part of the study may have previously received 2 doses of an approved/authorized mRNA or a non-mRNA COVID-19 vaccine (a heterologous vaccine regimen is acceptable).

Exclusion Criteria

• Participant had close contact (without personal protective equipment [PPE]) as defined by the Centers for Disease Control and Prevention (CDC) in the past 14 days to someone diagnosed with SARS-CoV-2 infection or COVID-19 within 10 days of the close contact. Participants may be rescreened after 14 days provided that they remain asymptomatic.
• Participant is acutely ill or febrile (temperature ≥ 38.0°C/100.4°F) 72 hours prior to or at the Screening Visit or Day 1.
• Participant has tested positive for SARS-CoV-2 by an authorized/approved lateral flow/rapid antigen or polymerase chain reaction (PCR) test within 90 days of Screening.
• Participant has received a COVID-19 vaccine within 90 days of the Screening Visit.
• Participant has received a total of 4 doses or more of COVID-19 vaccine.
• Participant has received a COVID-19 vaccine at a dose different from the authorized/approved dose.
• Any medical, psychiatric, or occupational condition, including reported history of substance abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results.
• Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 181 days prior to screening (for corticosteroids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study.
• Participant has received or plans to receive any licensed vaccine ≤28 days prior to the study injection (Day 1) or plans to receive a licensed vaccine within 28 days after the study injection (with the exception that approved seasonal influenza vaccine may be received by at least 7 days and preferably 14 days apart from the study injection).
• Participant has received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive during the study.
• Participant has donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products during the study.
• Participant has participated in an interventional clinical study within 28 days prior to the Screening Visit based on the medical history interview or plans to do so while participating in this study.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ModernaTX, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aberdeen Royal Infirmary - PPDS

Aberdeen, Aberdeenshire, United Kingdom

Southmead Hospital

Bristol, Avon, United Kingdom

Wansford and Kingscliffe Practice

Wansford, Cambridgeshire, United Kingdom

Halton General Hospital

Runcorn, Cheshire, United Kingdom

The James Cook University Hospital

Middlesbrough, Cleveland, United Kingdom

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Royal Devon and Exeter Hospital NHS Trust

Exeter, Devon, United Kingdom

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Gloucester Royal Hospital

Gloucester, Gloucestershire, United Kingdom

Portsmouth Research Hub

Portsmouth, Hampshire, United Kingdom

Fylde Coast Clinical Research

Blackpool, Lancashire, United Kingdom

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Salford Royal Hospital - PPDS

Salford, Manchester, United Kingdom

University College London Hospitals Covid-19 Vaccine Centre

London, Middlesex, United Kingdom

Castle Hill Hospital

Hull, North Humberside, United Kingdom

The Princess Royal Hospital

Telford, Shropshire, United Kingdom

Royal United Hospital

Bath, Somerset, United Kingdom

Sheffield/Northern General Hospital

Sheffield, South Yorkshire, United Kingdom

Royal Glamorgan Hospital - PPDS

Pont-y-clun, Wales, United Kingdom

Bradford Institute for Health Research

Bradford, West Yorkshire, United Kingdom

Great Western Hospital

Swindon, Wiltshire, United Kingdom

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Barts Hospital

London, , United Kingdom

Royal Free Hospital

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Chelsea and Westminster Hospital

London, , United Kingdom

St. George's Hospital

London, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Countries

United Kingdom

References

Lee IT, Cosgrove CA, Moore P, Bethune C, Nally R, Bula M, Kalra PA, Clark R, Dargan PI, Boffito M, Sheridan R, Moran E, Darton TC, Burns F, Saralaya D, Duncan CJA, Lillie PJ, San Francisco Ramos A, Galiza EP, Heath PT, Girard B, Parker C, Rust D, Mehta S, de Windt E, Sutherland A, Tomassini JE, Dutko FJ, Chalkias S, Deng W, Chen X, Feng J, Tracy L, Zhou H, Miller JM, Das R; Study Investigators. Omicron BA.1-containing mRNA-1273 boosters compared with the original COVID-19 vaccine in the UK: a randomised, observer-blind, active-controlled trial. Lancet Infect Dis. 2023 Sep;23(9):1007-1019. doi: 10.1016/S1473-3099(23)00295-5. Epub 2023 Jun 19.

Reference Type: DERIVED

PMID: 37348519 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2022-000063-51

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

mRNA-1273-P305

Identifier Type: -

Identifier Source: org_study_id