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

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05249829

Collaborator

(none)

3,924

Enrollment

Locations

Arms

13.6

Anticipated Duration (Months)

135.3

Patients Per Site

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2	Biological: mRNA-1273.529 Biological: mRNA-1273 Biological: mRNA-1273.214	Phase 2/Phase 3

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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3924 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Feb 16, 2022

Anticipated Primary Completion Date :

Apr 7, 2023

Anticipated Study Completion Date :

Apr 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part 1: mRNA-1273.529 Participants will receive 1 intramuscular (IM) dose of mRNA-1273.529 on Day 1.	Biological: mRNA-1273.529 Sterile liquid for injection
Active Comparator: Part 1: mRNA-1273 Participants will receive 1 IM dose of mRNA-1273 on Day 1.	Biological: mRNA-1273 Sterile liquid for injection
Experimental: Part 2: mRNA-1273.214 Participants will receive 1 IM dose of mRNA-1273.214 on Day 1.	Biological: mRNA-1273.214 Sterile liquid for injection
Active Comparator: Part 2: mRNA-1273 Participants will receive 1 IM dose of mRNA-1273 on Day 1.	Biological: mRNA-1273 Sterile liquid for injection

Outcome Measures

Primary Outcome Measures

Geometric Mean Titer (GMT) of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [Up to Day 179 post-vaccination]
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [Up to Day 8 (7 days post-vaccination)]
Number of Participants with Unsolicited Adverse Events (AEs) [Up to Day 29 (28 days post-vaccination)]
Number of Participants with Serious AEs (SAEs) [Day 1 to end of study (Day 359)]
Number of Participants with Medically Attended AEs (MAAEs) [Day 1 to end of study (Day 359)]
Number of Participants with AEs Leading to Withdrawal [Day 1 to end of study (Day 359)]
Number of Participants with AEs of Special Interest (AESIs) [Day 1 to end of study (Day 359)]
GMT of mRNA-1273.214 and mRNA-1273 Against the B1.1.529 Strain [Up to Day 179 post-vaccination]
GMT of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain [Up to Day 179 post-vaccination]

Secondary Outcome Measures

GMT of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [Days 1, 29, 85, 179, and 359]
GMT of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [Days 1, 29, 85, 179, and 359]
GMFR of mRNA-1273.529 and mRNA-1273 Against the Prototype Strain [Days 1, 29, 85, 179, and 359]
GMFR of mRNA-1273.529 and mRNA-1273 Against the B.1.1.529 Strain [Days 1, 29, 85, 179, and 359]
Seroresponse Rate of Vaccine Recipients [Days 1, 29, 85, 179, and 359]
GMT of mRNA-1273.214 and mRNA-1273 Against Other Variant Strains [Days 29, 85, and 179]
GMT of mRNA-1273.214 Against the B.1.1.529 Strain [Days 1, 29, 85, 179, and 359]
GMT of mRNA-1273.214 Against the Prototype Strain [Days 1, 29, 85, 179, and 359]
GMFR of mRNA-1273.214 and mRNA-1273 Against the B.1.1.529 Strain [Days 1, 29, 85, 179, and 359]
GMFR of mRNA-1273.214 and mRNA-1273 Against the Prototype Strain [Days 1, 29, 85, 179, and 359]
Number of Participants with Asymptomatic SARS-CoV-2 Infection Measured by Reverse Transcriptase Polymerase-chain Reaction (RT-PCR) [Day 1 to end of study (Day 359)]
Number of Participants with Symptomatic SARS-CoV-2 Infection Measured by RT-PCR [Day 1 to end of study (Day 359)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aberdeen Royal Infirmary - PPDS	Aberdeen	Aberdeenshire	United Kingdom	AB25 2ZD
2	Southmead Hospital	Bristol	Avon	United Kingdom	BS10 5NB
3	Wansford and Kingscliffe Practice	Wansford	Cambridgeshire	United Kingdom	PE8 6PL
4	Halton General Hospital	Runcorn	Cheshire	United Kingdom	WA7 2DA
5	The James Cook University Hospital	Middlesbrough	Cleveland	United Kingdom	TS4 3BW
6	Royal Cornwall Hospital	Truro	Cornwall	United Kingdom	TR1 3LJ
7	Royal Devon and Exeter Hospital NHS Trust	Exeter	Devon	United Kingdom	EX2 5DW
8	Royal Bournemouth Hospital	Bournemouth	Dorset	United Kingdom	BH7 7DW
9	Gloucester Royal Hospital	Gloucester	Gloucestershire	United Kingdom	GL1 3NN
10	Portsmouth Research Hub	Portsmouth	Hampshire	United Kingdom	PO1 3HN
11	Fylde Coast Clinical Research	Blackpool	Lancashire	United Kingdom	FY3 7EN
12	Leicester General Hospital	Leicester	Leicestershire	United Kingdom	LE5 4PW
13	Salford Royal Hospital - PPDS	Salford	Manchester	United Kingdom
14	University College London Hospitals Covid-19 Vaccine Centre	London	Middlesex	United Kingdom	WC1E 6EB
15	Castle Hill Hospital	Hull	North Humberside	United Kingdom	HU16 5JQ
16	The Princess Royal Hospital	Telford	Shropshire	United Kingdom	TF1 6TF
17	Royal United Hospital	Bath	Somerset	United Kingdom	BA1 3NG
18	Sheffield/Northern General Hospital	Sheffield	South Yorkshire	United Kingdom	S5 7AU
19	Royal Glamorgan Hospital - PPDS	Pontyclun	Wales	United Kingdom	CF72 8XR
20	Bradford Institute for Health Research	Bradford	West Yorkshire	United Kingdom	BD9 6RJ
21	Great Western Hospital	Swindon	Wiltshire	United Kingdom	SN3 6BB
22	Queen Elizabeth Hospital	Birmingham		United Kingdom	B15 2TH
23	Barts Hospital	London		United Kingdom	EC1A 7BE
24	Royal Free Hospital	London		United Kingdom	NW3 2QG
25	Kings College Hospital	London		United Kingdom	SE5 9RS
26	Chelsea and Westminster Hospital	London		United Kingdom	SW10 9NH
27	St. George's Hospital	London		United Kingdom	SW17 0RE
28	Royal Victoria Infirmary	Newcastle upon Tyne		United Kingdom	NE1 4LP
29	Derriford Hospital	Plymouth		United Kingdom	PL6 8DH