Clinical trial NCT05831111: A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1195, in 18- to 55-Year-Old Healthy Participants
Official title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, 2-Part, Dose-Ranging Study of an EBV Candidate Vaccine, mRNA-1195, in Healthy Participants 18 Through 55 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Epstein-Barr Virus Infection
Keywords: Infectious mononucleosis
Mononucleosis
Virus Diseases
Infections
Gamma-herpesvirus
Lead sponsor: ModernaTX, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 474
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety and reactogenicity of mRNA-1195 in healthy participants.

Detailed description: There will be 2 sequential parts to the study:

* Participants 18 through 55 years of age 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 participants 18 through 30 years of age who are either EBV-seronegative or EBV-seropositive at Screening.

Eligibility criteria: Key Inclusion Criteria:

* For Part A: Positive EBV serostatus at Screening. For Part B: Negative EBV serostatus or Positive EBV serostatus at Screening.
* According to the assessment of the Investigator, is in good general health and can comply with study procedures.
* For 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 3 months following last study injection and is not currently breast/chest feeding.

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 or authorized vaccine, to include COVID-19 vaccines, ≤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 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.

Primary outcomes:
measure: Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
timeFrame: Up to Day 176 (7-day follow-up after vaccination)
measure: Number of Participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 197 (28-day follow-up after vaccination)
measure: Number of Participants with Any Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Discontinuation of Study Intervention and/or Study Participation, and AEs of Special Interest (AESIs)
timeFrame: Part A and B: Day 1 to end of study (EOS) (Part A: Day 337; Part B: Day 505)
Secondary outcomes:
measure: Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)
timeFrame: Days 1, 85, and 197
measure: Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb
timeFrame: Days 1, 85, and 197
measure: Number of Participants With Seroresponse of B-Cell nAbs and/or Antigen-Specific bAbs
timeFrame: Days 1, 85, and 197
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Pinnacle Research Group, LLC
state: Alabama
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Dublin
country: United States
facility: West Coast Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Longmont
country: United States
facility: Tekton Research
state: Colorado
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Miami
country: United States
facility: Suncoast Research Group, LLC
state: Florida
city: Savannah
country: United States
facility: Velocity Clinical Research
state: Georgia
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: River Forest
country: United States
facility: DM Clinical Research- River Forest
state: Illinois
city: Sioux City
country: United States
facility: Velocity Clinical Research
state: Iowa
city: El Dorado
country: United States
facility: Alliance for Multispecialty Research
state: Kansas
city: Lenexa
country: United States
facility: Johnson County Clin-Trials, Inc (JCCT)
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research
state: Kentucky
city: Rockville
country: United States
facility: Velocity Clinical Research
state: Maryland
city: Brookline
country: United States
facility: DM Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Southfield
country: United States
facility: DM Clinical Research
state: Michigan
city: Kansas City
country: United States
facility: Alliance for Multispecialty Research
state: Missouri
city: Grand Island
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Hastings
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Lincoln
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research
state: Nebraska
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials, LLC
state: Nevada
city: Binghamton
country: United States
facility: Velocity Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc
state: New York
city: Raleigh
country: United States
facility: Eximia Clinical Research
state: North Carolina
city: Edmond
country: United States
facility: Tekton Research, Inc
state: Oklahoma
city: Moore
country: United States
facility: Tekton Research
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research, Inc - Yukon Location
state: Oklahoma
city: Philadelphia
country: United States
facility: DM Clinical Research - Philadelphia
state: Pennsylvania
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research Inc.
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: Sugar Land
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
Study officials:
References: