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

SARS-CoV-2 Clinical Trial

Official title:

A Phase 2/3, Randomized, Observer-blind, Active-controlled, Multicenter Study to Evaluate the Immunogenicity and Safety of Omicron Variant Vaccines in Comparison With mRNA-1273 (Prototype) Booster Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249829
• Other study ID #: mRNA-1273-P305
• Secondary ID: 2022-000063-51
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: February 16, 2022
• Est. completion date: June 23, 2023

Study information

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

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3557
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

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. Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

• SARS-CoV-2

Intervention

Biological:
• mRNA-1273.529
Sterile liquid for injection
• mRNA-1273
Sterile liquid for injection
• mRNA-1273.214
Sterile liquid for injection

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary - PPDS	Aberdeen	Aberdeenshire
United Kingdom	Royal United Hospital	Bath	Somerset
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Fylde Coast Clinical Research	Blackpool	Lancashire
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	Bradford Institute for Health Research	Bradford	West Yorkshire
United Kingdom	Southmead Hospital	Bristol	Avon
United Kingdom	Royal Devon and Exeter Hospital NHS Trust	Exeter	Devon
United Kingdom	Gloucester Royal Hospital	Gloucester	Gloucestershire
United Kingdom	Castle Hill Hospital	Hull	North Humberside
United Kingdom	Leicester General Hospital	Leicester	Leicestershire
United Kingdom	Barts Hospital	London
United Kingdom	Chelsea and Westminster Hospital	London
United Kingdom	Kings College Hospital	London
United Kingdom	Royal Free Hospital	London
United Kingdom	St. George's Hospital	London
United Kingdom	University College London Hospitals Covid-19 Vaccine Centre	London	Middlesex
United Kingdom	The James Cook University Hospital	Middlesbrough	Cleveland
United Kingdom	Royal Victoria Infirmary	Newcastle upon Tyne
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Glamorgan Hospital - PPDS	Pontyclun	Wales
United Kingdom	Portsmouth Research Hub	Portsmouth	Hampshire
United Kingdom	Halton General Hospital	Runcorn	Cheshire
United Kingdom	Salford Royal Hospital - PPDS	Salford	Manchester
United Kingdom	Sheffield/Northern General Hospital	Sheffield	South Yorkshire
United Kingdom	Great Western Hospital	Swindon	Wiltshire
United Kingdom	The Princess Royal Hospital	Telford	Shropshire
United Kingdom	Royal Cornwall Hospital	Truro	Cornwall
United Kingdom	Wansford and Kingscliffe Practice	Wansford	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain		Up to Day 85 post-vaccination
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 8 (7 days post-vaccination)
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 29 (28 days post-vaccination)
Primary	Number of Participants with Serious AEs (SAEs)		Day 1 to end of study (Day 359)
Primary	Number of Participants with Medically Attended AEs (MAAEs)		Day 1 to end of study (Day 359)
Primary	Number of Participants with AEs Leading to Withdrawal		Day 1 to end of study (Day 359)
Primary	Number of Participants with AEs of Special Interest (AESIs)		Day 1 to end of study (Day 359)
Primary	GMT of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain		Up to Day 85 post-vaccination
Primary	GMT of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain		Up to Day 85 post-vaccination
Secondary	GMT of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain		Days 1, 29, 85, 179, and 359
Secondary	GMT of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain		Days 1, 29, 85, 179, and 359
Secondary	Seroresponse Rate of Vaccine Recipients		Days 1, 29, 85, 179, and 359
Secondary	GMT of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains		Days 29 and 85
Secondary	Number of Participants with Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR)		Day 1 through the end of study (Day 359)
Secondary	Number of Participants with Symptomatic SARS-CoV-2 Infection Measured by RT-PCR		Day 1 through the end of study (Day 359)