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ACTIVE NOT RECRUITING Phase 1

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

NCT05164094 · View on ClinicalTrials.gov ↗

Study 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 is to evaluate the safety and reactogenicity of mRNA-1189 in 10- to 21-year-old healthy adolescents and adults.

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL mRNA-1189

Study Locations (20)

California

  • Smart Cures Clinical Research — Anaheim
  • Benchmark Research - Colton - HyperCore - PPDS — Colton
  • Fomat Medical Research — Oxnard
  • Center For Clinical Trials LLC -Paramount — Paramount
  • Artemis Institute For Clinical Research LLC - Riverside - Headlands - PPDS — Riverside
  • Peninsula Research Associates - Headlands Research - PPDS — Rolling Hills
  • Velocity Clinical Research - Banning - PPDS — San Bernardino
  • Acclaim Clinical Research — San Diego
  • California Research Foundation - 4180 Ruffin Rd — San Diego
  • Orange County Research Center — Tustin

Georgia

  • iResearch Savannah - CenExel - PPDS — Savannah
  • Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS — Savannah
  • Clinical Research Atlanta - Headlands - PPDS — Stockbridge

Florida

  • Research Centers of America - ERG — Hollywood
  • Jacksonville Center For Clinical Research - ERN - PPDS — Jacksonville

Illinois

  • Olivo Medical and Wellness Center — Chicago
  • DM Clinical Research — River Forest

Alabama

  • Medical Affiliated Research Institute — Huntsville

Arizona

  • Alliance for Multispecialty Research, LLC — Tempe

Idaho

  • Velocity Clinical Research — Meridian

Trial Details

FieldValue
Enrollment Target 867 participants
Start Date 2021-12-28
Est. Completion 2026-10-05
Phase Phase 1

Sponsor

ModernaTX

67 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05164094

The ClinicalTrials.gov registry entry for NCT05164094 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 867 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ModernaTX, which has 67 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Epstein-Barr Virus Infection appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05164094 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Georgia, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05164094 about?

NCT05164094 is a clinical study titled "A 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...

What is the current status of trial NCT05164094?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 867 participants. The study started on 2021-12-28. Estimated completion is 2026-10-05.

What conditions does trial NCT05164094 study?

This clinical trial studies the following conditions: Epstein-Barr Virus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05164094?

The interventions under investigation include: Placebo (BIOLOGICAL), mRNA-1189 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05164094?

This trial is sponsored by ModernaTX, which has 67 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05164094 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial