A Study of mRNA-based Influenza and SARS-CoV-2 (COVID-19) Multi-component Vaccines in Healthy Adults

Sponsor

ModernaTX, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05827926

Collaborator

(none)

1,224

Enrollment

Locations

Arms

10.5

Anticipated Duration (Months)

17.7

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to generate sufficient safety, reactogenicity, and immunogenicity data to enable selection of an mRNA-1083 vaccine composition and dose level to evaluate in a subsequent Phase 3 clinical trial in adults.

Condition or Disease	Intervention/Treatment	Phase
SARS-CoV-2 Influenza	Biological: Fluarix Biological: mRNA-1083.1 Biological: mRNA-1083.2 Biological: mRNA-1083.3 Biological: mRNA-1010.4 Biological: mRNA-1283.222 Biological: mRNA-1273.222 Biological: mRNA-1010 Biological: Fluzone HD	Phase 1/Phase 2

Detailed Description

Participants will be enrolled into 1 of 2 age cohorts: Cohort A for adults ≥65 to <80 years of age or Cohort B for adults ≥18 to <65 year of age. In Cohort A, approximately 600 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by influenza vaccine status in the most recent influenza season (received or not received since September 2022). In Cohort B, approximately 624 participants will be randomized (in equal allocation ratio) into the investigational treatment arms, stratified by 2 age groups: ≥18 to <50 years and ≥50 to <65 years of age and by influenza vaccine status in the most recent influenza season (received or not received since September 2022).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1224 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

A Phase 1/2, Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-based Influenza and SARS-CoV-2 Multi-component Vaccines in Healthy Adults

Actual Study Start Date :

Apr 14, 2023

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A2: mRNA-1083.1 Dose B Participants will receive single intramuscular (IM) injection of mRNA-1083.1 at Dose Level B on Day 1.	Biological: mRNA-1083.1 Sterile liquid for injection
Experimental: Cohort A3: mRNA-1083.1 Dose C Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.	Biological: mRNA-1083.1 Sterile liquid for injection
Experimental: Cohort A4: mRNA-1083.2 Dose A Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort A5: mRNA-1083.2 Dose B Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort A6: mRNA-1083.2 Dose C Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort A7: mRNA-1083.3 Participants will receive single IM injection of mRNA-1083.3 on Day 1.	Biological: mRNA-1083.3 Sterile liquid for injection
Active Comparator: Cohort A8: mRNA-1010.4 Participants will receive single IM injection of mRNA-1010.4 on Day 1.	Biological: mRNA-1010.4 Sterile liquid for injection
Active Comparator: Cohort A9: mRNA-1283.222 Participants will receive single IM injection of mRNA-1283.222 on Day 1.	Biological: mRNA-1283.222 Sterile liquid for injection
Active Comparator: Cohort A10: mRNA-1273.222 Participants will receive single IM injection of mRNA-1273.222 on Day 1.	Biological: mRNA-1273.222 Sterile liquid for injection
Active Comparator: Cohort A11: mRNA-1010 Participants will receive single IM injection of mRNA-1010 on Day 1.	Biological: mRNA-1010 Sterile liquid for injection
Active Comparator: Cohort A12: Fluarix Participants will receive single IM injection of Fluarix on Day 1.	Biological: Fluarix quadrivalent seasonal influenza vaccine
Active Comparator: Cohort A13: Fluzone HD Participants will receive single IM injection of Fluzone HD on Day 1.	Biological: Fluzone HD quadrivalent seasonal influenza vaccine
Experimental: Cohort B1: mRNA-1083.1 Dose A Participants will receive single IM injection of mRNA-1083.1 at Dose Level A on Day 1.	Biological: mRNA-1083.1 Sterile liquid for injection
Experimental: Cohort B2: mRNA-1083.1 Dose B Participants will receive single IM injection of mRNA-1083.1 at Dose Level B on Day 1.	Biological: mRNA-1083.1 Sterile liquid for injection
Experimental: Cohort B3: mRNA-1083.1 Dose C Participants will receive single IM injection of mRNA-1083.1 at Dose Level C on Day 1.	Biological: mRNA-1083.1 Sterile liquid for injection
Experimental: Cohort B4: mRNA-1083.2 Dose A Participants will receive single IM injection of mRNA-1083.2 at Dose Level A on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort B5: mRNA-1083.2 Dose B Participants will receive single IM injection of mRNA-1083.2 at Dose Level B on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort B6: mRNA-1083.2 Dose C Participants will receive single IM injection of mRNA-1083.2 at Dose Level C on Day 1.	Biological: mRNA-1083.2 Sterile liquid for injection
Experimental: Cohort B7: mRNA-1083.3 Participants will receive single IM injection of mRNA-1083.3 on Day 1.	Biological: mRNA-1083.3 Sterile liquid for injection
Active Comparator: Cohort B8: mRNA-1010.4 Participants will receive single IM injection of mRNA-1010.4 on Day 1.	Biological: mRNA-1010.4 Sterile liquid for injection
Active Comparator: Cohort B9: mRNA-1283.222 Participants will receive single IM injection of mRNA-1283.222 on Day 1.	Biological: mRNA-1283.222 Sterile liquid for injection
Active Comparator: Cohort B10: mRNA-1273.222 Participants will receive single IM injection of mRNA-1273.222 on Day 1.	Biological: mRNA-1273.222 Sterile liquid for injection
Active Comparator: Cohort B11: mRNA-1010 Participants will receive single IM injection of mRNA-1010 on Day 1.	Biological: mRNA-1010 Sterile liquid for injection
Active Comparator: Cohort B12: Fluarix Participants will receive single IM injection of Fluarix on Day 1.	Biological: Fluarix quadrivalent seasonal influenza vaccine

Outcome Measures

Primary Outcome Measures

Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [Up to Day 7 (7 days after vaccination)]
Number of Participants With Unsolicited Adverse Events (AEs) and Severe AEs [Up to Day 28 (28 days after vaccination)]
Number of Participants With Unsocilited Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study [Day 1 through Day 181]

Secondary Outcome Measures

Change From Baseline in Geometric Mean Titer (GMT) of Antibodies for Influenza, as Measured by Hemagglutination Inhibition (HAI) Assay [Baseline (Day 1), Day 29, and Day 181]
Change From Baseline in GMT of Antibodies for SARS-CoV-2, as Measured by Pseudovirus Neutralization Assay (PsVNA) [Baseline (Day 1), Day 29, and Day 181]
Change From Baseline in Geometric Mean Fold-Rise (GMFR) of Antibodies for Influenza, as Measured by HAI Assay [Baseline (Day 1), Day 29, and Day 181]
Change From Baseline in GMFR of Antibodies for SARS-CoV-2, as Measured by PsVNA [Baseline (Day 1), Day 29, and Day 181]
Influenza: Percentage of Participants with Seroconversion, as Measured by HAI Assay [Baseline (Day 1) to Day 29, and Day 181]
Seroconversion is defined as a Day 29 and Day 181 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
SARS-CoV-2: Percentage of Participants with Seroresponse, as Measured by PsVNA [Baseline (Day 1) to Day 29, and Day 181]
Seroresponse is defined as a Day 29 and Day 181 titer ≥4-fold if baseline is ≥lower limit of quantification (LLOQ) or ≥4*LLOQ if baseline titer is <LLOQ in neutralizing antibody (nAb) titers measured by PsVNA.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 79 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Key Inclusion Criteria:

Body mass index (BMI) of 18 kilograms (kg)/m2 to 35 kg/square meter (m^2) (inclusive) at the Screening Visit.
Healthy as determined by medical evaluation, including medical history, physical examination, and laboratory tests.
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 through 90 days following vaccine administration, and not currently breastfeeding.
Fully vaccinated for COVID-19 primary series according to the locally authorized or approved regimen, and their last COVID-19 vaccine (primary series or booster) was ≥120 days prior to Day 1.

Key Exclusion Criteria:

Participant is acutely ill or febrile (temperature ≥38.0 degrees Celsius [°C]/100.4 degrees Fahrenheit [°F]) 72 hours prior to or at the Screening Visit or Day 1.
Any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, that, in the opinion of the Investigator, might pose additional risk due to participation in the clinical trial or could interfere with the interpretation of study results.
Participant has received systemic immunosuppressants for >14 days in total within 180 days prior to Screening Visit (for glucocorticoids ≥10 milligrams [mg]/day of prednisone or equivalent) or is anticipating the need for systemic immunosuppressive treatment at any time during participation in the clinical trial (including intra-articular steroid injections). Inhaled, nasal, and topical steroids are allowed.
Participant has received or plans to receive any vaccine authorized or approved by a local health agency ≤28 days prior to study intervention administration or plans to receive a vaccine authorized or approved by a local health agency within 28 days after study intervention administration.
Participant has received a seasonal influenza vaccine or any other investigational influenza vaccine within 150 days prior to Day 1.
Participant tested positive for influenza by local health authority-approved testing methods ≤150 days prior to Day 1.
Participant has had close contact to someone with COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) in the past 10 days prior to Day 1.
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 clinical trial.

Note: Other inclusion/exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chandler Clinical Trials	Chandler	Arizona	United States	85224-6231
2	Benchmark Research	Colton	California	United States	92324
3	Marvel Clinical Research	Huntington Beach	California	United States	92647-6835
4	Central Valley Research	Modesto	California	United States	95350-5365
5	Benchmark Research	Sacramento	California	United States	95864-3102
6	Tekton Research	Longmont	Colorado	United States	80501-6461
7	Accel Research Sites	DeLand	Florida	United States	32720-0834
8	CenExel	Hollywood	Florida	United States	33024
9	Nature Coast Clinical Research	Inverness	Florida	United States	34452
10	Jacksonville Center For Clinical Research	Jacksonville	Florida	United States	32216
11	Accel Research Sites	Maitland	Florida	United States	32751
12	Suncoast Research Group	Miami	Florida	United States	33135-1687
13	Centricity Research	Columbus	Georgia	United States	31904
14	Accel Research Site	Decatur	Georgia	United States	30030-2615
15	CenExel iResearch	Decatur	Georgia	United States	30030
16	Lifeline Primary Care	Lilburn	Georgia	United States	30047-2832
17	Koch Family Medicine	Morton	Illinois	United States	61550
18	Optimal Research	Peoria	Illinois	United States	61614-4885
19	DM Clinical Research	River Forest	Illinois	United States	60305-1876
20	Johnson County Clin-Trials	Lenexa	Kansas	United States	66219-1389
21	Tekton Research	Wichita	Kansas	United States	67218-2913
22	Versailles Family Medicine	Versailles	Kentucky	United States	40383-1947
23	Velocity Clinical research	Baton Rouge	Louisiana	United States	70809
24	Benchmark Research	Metairie	Louisiana	United States	70006
25	DelRicht Research	New Orleans	Louisiana	United States	70115
26	DelRicht Research	Prairieville	Louisiana	United States	70769
27	Annapolis Internal Medicine	Annapolis	Maryland	United States	21401
28	Velocity Clinical Research	Rockville	Maryland	United States	20854
29	DM Clinical Research	Brookline	Massachusetts	United States	02445-7113
30	Vida Clinical Studies	Dearborn Heights	Michigan	United States	48127-2234
31	DelRicht Research	Gulfport	Mississippi	United States	39503
32	Clay Platte Family Medicine	Kansas City	Missouri	United States	64151-2411
33	Velocity Clinical Research	Lincoln	Nebraska	United States	68510
34	Velocity Clinical Research	Norfolk	Nebraska	United States	68701
35	Excel Clinical Research	Las Vegas	Nevada	United States	89109-6209
36	CCT Research	Las Vegas	Nevada	United States	89119
37	Las Vegas Clinical Trials	North Las Vegas	Nevada	United States	89030-7193
38	Rochester Clinical Research	Rochester	New York	United States	14609-3169
39	Tryon Medical Partners	Charlotte	North Carolina	United States	28210
40	Trial Management Associates	Wilmington	North Carolina	United States	28403-6238
41	CTI Clinical Research Center	Cincinnati	Ohio	United States	45212
42	Velocity Clinical Research	Cincinnati	Ohio	United States	45219
43	Velocity Clinical Research	Cincinnati	Ohio	United States	45246
44	Centricity Research	Columbus	Ohio	United States	43213
45	WellNow Urgent Care & Research	Dayton	Ohio	United States	45424-4019
46	Lynn Institute of East Oklahoma	Oklahoma City	Oklahoma	United States	73111-3324
47	DelRicht Research	Tulsa	Oklahoma	United States	74133
48	Tekton Research Inc	Yukon	Oklahoma	United States	73099-9518
49	DM Clinical Research	Philadelphia	Pennsylvania	United States	19107-1530
50	Mercado Medical Practice	Philadelphia	Pennsylvania	United States	19111-2432
51	DelRicht Research	Charleston	South Carolina	United States	29407
52	Trial Management Associates	Myrtle Beach	South Carolina	United States	29572-4612
53	Medical Care	Elizabethton	Tennessee	United States	37643
54	DelRicht Research	Hendersonville	Tennessee	United States	37075
55	Benchmark Research	Austin	Texas	United States	78705-3298
56	Tekton Research	Austin	Texas	United States	78745-1470
57	Tekton Research	Beaumont	Texas	United States	77706-3061
58	Benchmark Research	Fort Worth	Texas	United States	76135
59	Cyfair Clinical Research	Houston	Texas	United States	77065
60	Texas Center for Drug Development	Houston	Texas	United States	77081
61	DelRicht Research	McKinney	Texas	United States	75070
62	Benchmark Research	San Angelo	Texas	United States	76904-7610
63	Tekton Research	San Antonio	Texas	United States	78229
64	CCT Research	Pleasant View	Utah	United States	84404
65	Ogden Clinic	Roy	Utah	United States	84067
66	JBR Clinical Research	Salt Lake City	Utah	United States	84107
67	Meridian Clinical Research	Hampton	Virginia	United States	23666
68	Velocity Clinical Research	Portsmouth	Virginia	United States	23703
69	Wenatchee Valley Hospital & Clinics Campus	Wenatchee	Washington	United States	98801