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A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults

Primary Purpose

Epstein-Barr Virus Infection

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
mRNA-1195.1
mRNA-1195.2
mRNA-1189
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epstein-Barr Virus Infection focused on measuring Infectious mononucleosis, Mononucleosis, Virus Diseases, Infections, Gamma-herpesvirus

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Key Inclusion Criteria: For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus at Screening. According to the assessment of the Investigator, is in good general health and can comply with study procedures. 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, and agreement to continue adequate contraception through 3 months following vaccine administration. 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. Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator). 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 study or could interfere with the interpretation of study results. History of myocarditis, pericarditis, or myopericarditis. Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (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. Topical corticosteroids and tacrolimus are allowed. Participant has received or plans to receive any licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza or SARS-CoV-2 vaccines, which may be received more than 14 days before or after any study injection. 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. Note: Other inclusion and exclusion criteria may apply.

Sites / Locations

  • Pinnacle Research Group, LLC
  • Noble Clinical ResearchRecruiting
  • Marvel Clinical ResearchRecruiting
  • Longmonth Medical Research Network
  • Suncoast Research Group, LLC
  • Meridian Clinical Research - Savannah
  • Optimal ResearchRecruiting
  • DM Clinical Research- River ForestRecruiting
  • Meridian Clinical Research
  • Johnson County Clin-Trials, Inc (JCCT)Recruiting
  • Velocity Clinical ResearchRecruiting
  • DM Clinical ResearchRecruiting
  • University of Mass Medical School
  • DM Clinical ResearchRecruiting
  • Meridian Clinical ResearchRecruiting
  • Velocity Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical Research
  • Meridian Clinical ResearchRecruiting
  • Las Vegas Clinical Trials, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Rochester Clinical Research, IncRecruiting
  • Tekton Research, Inc
  • Tekton Research, Inc - Yukon LocationRecruiting
  • DM Clinical Research - PhiladelphiaRecruiting
  • Alliance for Multispecialty Research, LLC
  • Benchmark ResearchRecruiting
  • Tekton Research Inc.Recruiting
  • CyFairRecruiting
  • Research Your HealthRecruiting
  • DM Clinical ResearchRecruiting
  • DM Clinical ResearchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Part A: mRNA-1195.1 Dose Level 1

Part A: mRNA-1195.2 Dose Level 1

Part A: mRNA-1195.1 Dose Level 2

Part A: mRNA-1195.2 Dose Level 2

Part A: mRNA-1195.1 Dose Level 3

Part A: mRNA-1195.2 Dose Level 3

Part A: mRNA-1195.1 Dose Level 4

Part A: mRNA-1195.2 Dose Level 4

Part A: mRNA-1189

Part A: Placebo

Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose

Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose

Part B: mRNA-1195.1 or mRNA-1195.2 High Dose

Part B: mRNA-1189

Part B: Placebo

Arm Description

Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.

Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.

Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.

Outcomes

Primary Outcome Measures

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Participants with Unsolicited Adverse Events (AEs)
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs)

Secondary Outcome Measures

Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb
Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs

Full Information

First Posted
April 14, 2023
Last Updated
June 12, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05831111
Brief Title
A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults
Official Title
A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Adults 18 to 55 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
February 4, 2026 (Anticipated)
Study Completion Date
February 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy adults (18 to 55 years of age).
Detailed Description
There will be 2 sequential parts to the study: Participants will be enrolled in Part A of the study first, which will only enroll those participants who are EBV-seropositive at Screening. Part B will enroll only those participants who are EBV-seronegative at Screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epstein-Barr Virus Infection
Keywords
Infectious mononucleosis, Mononucleosis, Virus Diseases, Infections, Gamma-herpesvirus

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Part A: mRNA-1195.1 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive 3 intramuscular (IM) injections of mRNA-1195.1 at Dose Level 1 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.2 Dose Level 1
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 1 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.1 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 2 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.2 Dose Level 2
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 2 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.1 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 3 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.2 Dose Level 3
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 3 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.1 Dose Level 4
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 at Dose Level 4 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1195.2 Dose Level 4
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.2 at Dose Level 4 on Days 1, 57, and 169.
Arm Title
Part A: mRNA-1189
Arm Type
Active Comparator
Arm Description
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Arm Title
Part A: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.
Arm Title
Part B: mRNA-1195.1 or mRNA-1195.2 Low Dose
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) low dose on Days 1, 57, and 169.
Arm Title
Part B: mRNA-1195.1 or mRNA-1195.2 Middle Dose
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) middle dose on Days 1, 57, and 169.
Arm Title
Part B: mRNA-1195.1 or mRNA-1195.2 High Dose
Arm Type
Experimental
Arm Description
Participants will receive 3 IM injections of mRNA-1195.1 or mRNA-1195.2 (at a dose level selected based on the Part A interim analysis) high dose on Days 1, 57, and 169.
Arm Title
Part B: mRNA-1189
Arm Type
Active Comparator
Arm Description
Participants will receive 3 IM injections of mRNA-1189 on Days 1, 57, and 169.
Arm Title
Part B: Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IM injection of study drug-matching placebo on Days 1, 57, and 169.
Intervention Type
Biological
Intervention Name(s)
mRNA-1195.1
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1195.2
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
mRNA-1189
Intervention Description
Sterile liquid for injection
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Primary Outcome Measure Information:
Title
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 176
Title
Number of Participants with Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 197 (28-day follow-up after vaccination)
Title
Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine, and AEs of Special Interest (AESIs)
Time Frame
Day 1 to end of study (EOS) (Day 337)
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
Time Frame
Days 1, 85, and 197
Title
Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb
Time Frame
Days 1, 85, and 197
Title
Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs
Time Frame
Days 1, 85, and 197

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Key Inclusion Criteria: For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus at Screening. According to the assessment of the Investigator, is in good general health and can comply with study procedures. 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, and agreement to continue adequate contraception through 3 months following vaccine administration. 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. Symptomatic acute or chronic illness requiring ongoing medical or surgical care, to include changes in medication in the past 2 months indicating that chronic illness/disease is not stable (at the discretion of the Investigator). 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 study or could interfere with the interpretation of study results. History of myocarditis, pericarditis, or myopericarditis. Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening Visit (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. Topical corticosteroids and tacrolimus are allowed. Participant has received or plans to receive any licensed vaccine ≤28 days prior to the first injection (Day 1) or plans to receive a licensed vaccine within 28 days before or after any study injection, with the exception of licensed/authorized influenza or SARS-CoV-2 vaccines, which may be received more than 14 days before or after any study injection. 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. Note: Other inclusion and exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Pinnacle Research Group, LLC
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36207
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Noble Clinical Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Marvel Clinical Research
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Longmonth Medical Research Network
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Suncoast Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Meridian Clinical Research - Savannah
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Optimal Research
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research- River Forest
City
River Forest
State/Province
Illinois
ZIP/Postal Code
60305
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Johnson County Clin-Trials, Inc (JCCT)
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Mass Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
DM Clinical Research
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Individual Site Status
Recruiting
Facility Name
Meridian Clinical Research
City
Grand Island
State/Province
Nebraska
ZIP/Postal Code
68803
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Hastings
State/Province
Nebraska
ZIP/Postal Code
68901
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Meridian Clinical Research
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68510
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Individual Site Status
Recruiting
Facility Name
Las Vegas Clinical Trials, LLC
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Name
Velocity Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
13905
Country
United States
Individual Site Status
Recruiting
Facility Name
Rochester Clinical Research, Inc
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research, Inc
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Tekton Research, Inc - Yukon Location
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
Alliance for Multispecialty Research, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Tekton Research Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Individual Site Status
Recruiting
Facility Name
CyFair
City
Houston
State/Province
Texas
ZIP/Postal Code
77065
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Your Health
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Individual Site Status
Recruiting
Facility Name
DM Clinical Research
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Adults

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