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

Epstein-Barr Virus Infection Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05831111
• Other study ID #: mRNA-1195-P101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: April 5, 2023
• Est. completion date: February 4, 2026

Study information

• Verified date: January 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 354
• Est. completion date: February 4, 2026
• Est. primary completion date: February 4, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epstein-Barr Virus Infection
• Epstein-Barr Virus Infections

Intervention

Biological:
• mRNA-1195.1
Sterile liquid for injection
• mRNA-1195.2
Sterile liquid for injection
• mRNA-1189
Sterile liquid for injection
• Placebo
0.9% sodium chloride (normal saline) injection

Locations

Country	Name	City	State
United States	Pinnacle Research Group, LLC	Anniston	Alabama
United States	Benchmark Research	Austin	Texas
United States	Tekton Research Inc.	Austin	Texas
United States	Velocity Clinical Research	Binghamton	New York
United States	DM Clinical Research	Brookline	Massachusetts
United States	Tekton Research, Inc	Edmond	Oklahoma
United States	Meridian Clinical Research	Grand Island	Nebraska
United States	Velocity Clinical Research	Hastings	Nebraska
United States	CyFair	Houston	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	Las Vegas Clinical Trials, LLC	Las Vegas	Nevada
United States	Johnson County Clin-Trials, Inc (JCCT)	Lenexa	Kansas
United States	Meridian Clinical Research	Lincoln	Nebraska
United States	Longmonth Medical Research Network	Longmont	Colorado
United States	Suncoast Research Group, LLC	Miami	Florida
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Optimal Research	Peoria	Illinois
United States	DM Clinical Research - Philadelphia	Philadelphia	Pennsylvania
United States	Research Your Health	Plano	Texas
United States	DM Clinical Research- River Forest	River Forest	Illinois
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Velocity Clinical Research	Rockville	Maryland
United States	Meridian Clinical Research - Savannah	Savannah	Georgia
United States	Meridian Clinical Research	Sioux City	Iowa
United States	DM Clinical Research	Southfield	Michigan
United States	DM Clinical Research	Sugar Land	Texas
United States	DM Clinical Research	Tomball	Texas
United States	Noble Clinical Research	Tucson	Arizona
United States	University of Mass Medical School	Worcester	Massachusetts
United States	Tekton Research, Inc - Yukon Location	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)		Up to Day 176
Primary	Number of Participants with Unsolicited Adverse Events (AEs)		Up to Day 197 (28-day follow-up after vaccination)
Primary	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)		Day 1 to end of study (EOS) (Day 337)
Secondary	Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb)		Days 1, 85, and 197
Secondary	Geometric Mean Fold Rise (GMFR) of B-Cell nAb and/or Antigen-Specific bAb		Days 1, 85, and 197
Secondary	Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs		Days 1, 85, and 197