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Epstein-Barr Virus InfectionPhase 1/2NCT05164094

A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults

A Phase 1/2 study testing mRNA-1189 in people with Epstein-Barr Virus Infection, run by ModernaTX, Inc. at 65 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

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, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C… Read more about this study

Who is it for?
Ages 10 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Epstein-Barr Virus Infection
What is being tested?
mRNA-1189
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
867 participants
Where
65 sitesUnited States
Study dates
28 Dec 2021to 18 Aug 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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 baseline EBV-seronegative adolescents from 12 to <18 years of age at the time of consent (Screening Visit, Day 0).
  • Part C:
  • Healthy adolescents and adults from 10 to 21 years of age (inclusive) at the time of consent (Screening Visit, Day 0).

Who cannot join

  • 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.

Trial locations and contacts

65 sites in 1 country.

65 sites in 1 country

United States65 sites

  • Smart Cures Clinical Research

    Anaheim, California, 92806

  • Velocity Clinical Research

    Anderson, South Carolina, 29621

  • Benchmark Research - Austin - PPDS

    Austin, Texas, 78705

  • Tekton Research - Texas - Platinum - PPDS

    Austin, Texas, 78745

  • Velocity Clinical Research - Binghamton

    Binghamton, New York, 13901

  • ACRC Trials - Hunt - PPDS

    Carrollton, Texas, 75010

  • Velocity Clinical Research - Austin - PPDS

    Cedar Park, Texas, 78613-3936

  • Coastal Pediatric Associates

    Charleston, South Carolina, 29414-5834

  • Charlottesville Medical Research Center

    Charlottesville, Virginia, 22911

  • Olivo Medical and Wellness Center

    Chicago, Illinois, 60618-8101

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45219

  • Benchmark Research - Colton - HyperCore - PPDS

    Colton, California, 92324

  • Cedar Health Research - Fort Worth - PPDS

    Dallas, Texas, 75251

  • Velocity Clinical Research

    East Syracuse, New York, 13057

  • Alliance for Multispecialty Research, LLC - El Dorado - PPDS

    El Dorado, Kansas, 67042-2187

  • Benchmark Research - Fort Worth - HyperCore - PPDS

    Fort Worth, Texas, 76135

  • ACRC Trials

    Frisco, Texas, 75024

  • Velocity Clinical Research - Grand Island

    Grand Island, Nebraska, 68803

  • CenExel iResearch, LLC

    Hollywood, Florida, 33024

  • Helios Clinical Research

    Houston, Texas, 77008

  • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

    Houston, Texas, 77065

  • Medical Affiliated Research Institute

    Huntsville, Alabama, 35801

  • Jacksonville Center For Clinical Research - ERN - PPDS

    Jacksonville, Florida, 32216-4357

  • Velocity Clinical Research - Lafayette - PPDS

    Lafayette, Louisiana, 70508-5173

  • Alliance for Multispecialty Research, LLC

    Las Vegas, Nevada, 89119

  • Tanner Clinic

    Layton, Utah, 84041

  • Johnson County Clin-Trials

    Lenexa, Kansas, 66219

  • Michael W Simon MD, PSC

    Lexington, Kentucky, 40517-8379

  • Velocity Clinical Research - Lincoln

    Lincoln, Nebraska, 68510

  • Velocity Clinical Research

    Meridian, Idaho, 83642

  • Clinical Research Institute, Inc.

    Minneapolis, Minnesota, 55402

  • Lucas Research

    Morehead City, North Carolina, 28557

  • Lucas Research

    New Bern, North Carolina, 28562

  • Health Research of Hampton Roads Inc. - Newport News

    Newport News, Virginia, 23606-4537

  • Velocity Clinical Research - Norfolk

    Norfolk, Nebraska, 68701

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research - ClinEdge - PPDS

    Omaha, Nebraska, 68112

  • Velocity Clinical Research - Omaha

    Omaha, Nebraska, 68134

  • Fomat Medical Research

    Oxnard, California, 93030

  • Center For Clinical Trials LLC -Paramount

    Paramount, California, 90723-5459

  • ACRC Trials - Legacy Medical Village Headquarters

    Plano, Texas, 75024-4174

  • Clinical Research Partners LLC - Richmond - ERN - PPDS

    Richmond, Virginia, 23226-3787

  • DM Clinical Research

    River Forest, Illinois, 60305

  • Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS

    Riverside, California, 92503

  • Peninsula Research Associates - Headlands Research - PPDS

    Rolling Hills, California, 90274

  • Velocity Clinical Research - Banning - PPDS

    San Bernardino, California, 92220-3082

  • Acclaim Clinical Research

    San Diego, California, 92120

  • California Research Foundation - 4180 Ruffin Rd

    San Diego, California, 92123-1881

  • iResearch Savannah - CenExel - PPDS

    Savannah, Georgia, 31405

  • Velocity Clinical Research - Savannah

    Savannah, Georgia, 31406

  • Velocity Clinical Research - Sioux City

    Sioux City, Iowa, 51106

  • Senders Pediatrics

    South Euclid, Ohio, 44121

  • Great Lakes Research Institute

    Southfield, Michigan, 48075

  • DM Clinical Research

    Southfield, Michigan, 48076

  • Sundance Clinical Research - ERN - PPDS

    St Louis, Missouri, 63141

  • Clinical Research Atlanta - Headlands - PPDS

    Stockbridge, Georgia, 30281-9054

  • DM Clinical Research - Texas Center For Drug Development - ERN - PPDS

    Tomball, Texas, 77375

  • Orange County Research Center

    Tustin, California, 92780

  • Velocity Clinical Research

    Valparaiso, Indiana, 46383

  • Velocity Clinical Research - Vestal

    Vestal, New York, 13850

  • Victoria Clinical Research Group

    Victoria, Texas, 77979

  • Alliance for Multispecialty Research LLC, East Wichita

    Wichita, Kansas, 67207

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Phase 1/2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 10- to 30-Year-Old Healthy Adolescents and Adults

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, the main objective of Part B is to evaluate the safety and reactogenicity of mRNA-1189 in 12- to <18-year-old healthy EBV-seronegative adolescents, and the main objective of Part C is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.

Being tested
mRNA-1189, Placebo
Keywords
Infectious mononucleosis, Mononucleosis
Medical subject headings
Epstein-Barr Virus Infections, Infectious Mononucleosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA-1189Biological

    Sterile liquid for injection

  • PlaceboBiological

    0.9% sodium chloride (normal saline) injection

Study groups in NCT05164094
Study groupRoleWhat they receive
Part A: mRNA-1189 Dose Level 2ExperimentalParticipants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part A: mRNA-1189 Dose Level 3ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part A: mRNA-1189 Dose Level 4ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part A: PlaceboPlacebo comparatorParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Receives: Biological: Placebo
Part B: mRNA-1189 Dose Level 1ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 2ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 3ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part B: mRNA-1189 Dose Level 4ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 4 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part B: PlaceboPlacebo comparatorParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Receives: Biological: Placebo
Part C: mRNA-1189 Dose Level 1ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part C: mRNA-1189 Dose Level 2ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part C: mRNA-1189 Dose Level 3ExperimentalParticipants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169.
Receives: Biological: mRNA-1189
Part C: PlaceboPlacebo comparatorParticipants will receive 3 IM injection of study drug-matching placebo on Days 1, 57, and 169.
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Measured: Up to Day 176 (7-day follow-up after vaccination)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Measured: Up to Day 197 (28-day follow-up after vaccination)

  3. Number of Participants with SAEs, MAAEs, Any AEs Leading to Withdrawal From Study/Discontinuation of Study Vaccine and AEs of Special Interest (AESIs)

    Measured: Day 1 to end of study (EOS) (Day 505)

  4. Number of Participants with Laboratory Abnormalities

    Measured: Up to Day 176 (7-day follow-up after vaccination)

Secondary outcomes (4)

  1. Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb)

    Measured: Days 1, 85, and 197

  2. Geometric Mean Concentration (GMC) of Antigen-specific Binding Antibody (bAb)

    Measured: Days 1, 85, and 197

  3. Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-specific bAb

    Measured: Days 1, 85, and 197

  4. Number of Participants with Seroresponse of B-Cell nAbs and Antigen-specific bAbs

    The number of participants with seroresponse for EBV-specific (vaccine antigen) binding and nAbs responses and with >2-, 3-, and 4-fold increases in serum binding or nAb titers from baseline will be analyzed with 2-sided 95% CI using the Clopper-Pearson method by treatment arm and baseline EBV serostatus, and timepoint.

    Measured: Days 1, 85, and 197

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2021
  2. Study start28 Dec 2021
  3. Primary completion5 Oct 2026 (estimated)
  4. Study completion18 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
867 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05164094
Sponsor's protocol ID
mRNA-1189-P101
Status last verified
May 2026
First submitted
1 Dec 2021
Last updated
6 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Green M, Michaels MG, Gross T, Allen U, Bollard CM, Martinez O, Yamada M, Swerdlow SH. The IPTA Nashville Consensus Conference on Post-Transplant Lymphoproliferative Disorders After Solid Organ Transplantation in Children: Updates on Classification and Prevention-2026. Pediatr Transplant. 2026 Sep;30(9):e70445. doi: 10.1111/petr.70445.

    PubMed 42720126

  • Malpica L, Marques-Piubelli ML, Beltran BE, Chavez JC, Miranda RN, Castillo JJ. EBV-positive diffuse large B-cell lymphoma, not otherwise specified: 2024 update on the diagnosis, risk-stratification, and management. Am J Hematol. 2024 Oct;99(10):2002-2015. doi: 10.1002/ajh.27430. Epub 2024 Jul 3.

    PubMed 38957951

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing mRNA-1189 in people with Epstein-Barr Virus Infection, run by ModernaTX, Inc. at 65 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) (time frame: Up to Day 176 (7-day follow-up after vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05164094, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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