A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

Epstein-Barr Virus Infection Clinical Trial

Official title:

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 12- to 30-Year-Old Healthy Adolescents and Adults

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05164094
• Other study ID #: mRNA-1189-P101
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: December 28, 2021
• Est. completion date: June 18, 2025

Study information

• Verified date: November 2023
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of Part A of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults and the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old EBV-seronegative healthy adolescents.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 422
• Est. completion date: June 18, 2025
• Est. primary completion date: June 18, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• According to the assessment of the investigator, is in good general health and can comply with study procedures. Part A: Healthy adult from 18 to 30 years of age (inclusive) at the time of consent (Screening Visit, Day 0). Part B: Healthy adolescent from 12 to <18 years of age at the time of consent (Screening Visit, Day 0). EBV - seronegative as determined by serology at screening.

Exclusion Criteria:

• Has had significant exposure to someone with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection or COVID-19 in the past 14 days prior to the screening visit, if the participant has not been fully vaccinated against COVID-19 at least 14 days prior to the screening visit.
• Has 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).
• Significant, progressive, unstable or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures per investigator judgement.
• Has a history of myocarditis, and/or pericarditis.
• 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 vaccine injection, with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study vaccine injection. Note: Other inclusion and exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Smart Cures Clinical Research	Anaheim	California
United States	Velocity Clinical Research	Anderson	South Carolina
United States	Benchmark Research - Austin - PPDS	Austin	Texas
United States	Tekton Research - Texas - Platinum - PPDS	Austin	Texas
United States	Velocity Clinical Research - Banning - PPDS	Banning	California
United States	Meridian Clinical Research	Binghamton	New York
United States	ACRC Trials - Hunt - PPDS	Carrollton	Texas
United States	Velocity Clinical Research - Austin - PPDS	Cedar Park	Texas
United States	Coastal Pediatric Associates	Charleston	South Carolina
United States	Charlottesville Medical Research Center	Charlottesville	Virginia
United States	Olivo Medical and Wellness Center	Chicago	Illinois
United States	Meridian Clinical Research	Cincinnati	Ohio
United States	Benchmark Research - Colton - HyperCore - PPDS	Colton	California
United States	Cedar Health Research - Fort Worth - PPDS	Dallas	Texas
United States	Velocity Clinical Research	East Syracuse	New York
United States	Alliance for Multispecialty Research, LLC - El Dorado - PPDS	El Dorado	Kansas
United States	Meridian Clinical Research	Endwell	New York
United States	Benchmark Research - Fort Worth - HyperCore - PPDS	Fort Worth	Texas
United States	Meridian Clinical Research (Grand Island, Nebraska)	Grand Island	Nebraska
United States	Research Centers of America - ERG	Hollywood	Florida
United States	DM Clinical Research - Texas Center For Drug Development - ERN - PPDS	Houston	Texas
United States	DM Clinical Research - Texas Center For Drug Development - ERN - PPDS	Houston	Texas
United States	Ventavia Research Group	Houston	Texas
United States	Medical Affiliated Research Institute	Huntsville	Alabama
United States	Jacksonville Center For Clinical Research - ERN - PPDS	Jacksonville	Florida
United States	Velocity Clinical Research - Lafayette - PPDS	Lafayette	Louisiana
United States	Alliance for Multispecialty Research, LLC	Las Vegas	Nevada
United States	Tanner Clinic	Layton	Utah
United States	Johnson County Clin-Trials	Lenexa	Kansas
United States	Michael W Simon MD, PSC	Lexington	Kentucky
United States	Velocity Clinical Research	Meridian	Idaho
United States	Care Access Network	Mesa	Arizona
United States	Clinical Research Institute, Inc.	Minneapolis	Minnesota
United States	Lucas Research	Morehead City	North Carolina
United States	Lucas Research	New Bern	North Carolina
United States	Health Research of Hampton Roads Inc. - Newport News	Newport News	Virginia
United States	Alliance for Multispecialty Research, LLC	Norfolk	Virginia
United States	Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS	Norfolk	Nebraska
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research, LLC (Lincoln Nebraska)	Omaha	Nebraska
United States	Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS	Omaha	Nebraska
United States	Quality Clinical Research - ClinEdge - PPDS	Omaha	Nebraska
United States	Fomat Medical Research	Oxnard	California
United States	Center For Clinical Trials LLC -Paramount	Paramount	California
United States	ACRC Trials	Plano	Texas
United States	ACRC Trials - Legacy Medical Village Headquarters	Plano	Texas
United States	Clinical Research Partners LLC - Richmond - ERN - PPDS	Richmond	Virginia
United States	DM Clinical Research	River Forest	Illinois
United States	Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS	Riverside	California
United States	Peninsula Research Associates - Headlands Research - PPDS	Rolling Hills	California
United States	Sundance Clinical Research - ERN - PPDS	Saint Louis	Missouri
United States	Acclaim Clinical Research	San Diego	California
United States	California Research Foundation - 4180 Ruffin Rd	San Diego	California
United States	iResearch Savannah - CenExel - PPDS	Savannah	Georgia
United States	Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS	Savannah	Georgia
United States	Meridian Clinical Research, LLC	Sioux City	Iowa
United States	DM Clinical Research	Southfield	Michigan
United States	Clinical Research Atlanta - Headlands - PPDS	Stockbridge	Georgia
United States	Alliance for Multispecialty Research, LLC	Tempe	Arizona
United States	Orange County Research Center	Tustin	California
United States	Velocity Clinical Research	Valparaiso	Indiana
United States	Victoria Clinical Research Group	Victoria	Texas
United States	Alliance for Multispecialty Research LLC, East Wichita	Wichita	Kansas
United States	UMass Memorial Medical Center	Worcester	Massachusetts

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 (7-day follow-up after vaccination)
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 505)
Primary	Number of Participants with Laboratory Abnormalities		Up to Day 176 (7-day follow-up after vaccination)
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 Antigen-Specific bAb		Days 1, 85, and 197
Secondary	Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs	The number of initially EBV-negative participants with seroconversion from below the lower limit of quantification (LLOQ) to above the LLOQ for EBV-specific (vaccine antigen) binding and nAbs responses and the initially EBV-positive participants with > 2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline (if above LLOQ) will be analyzed.	Days 1, 85, and 197