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Active, Not Recruiting

NCT Number: NCT05164094

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Medical Affiliated Research Institute, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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).

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.

Treatment and study plan

mRNA-1189

Biological

Sterile liquid for injection

Placebo

Biological

0.9% sodium chloride (normal saline) injection

Primary outcomes

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

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

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

    Time frame: 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)

    Time frame: Day 1 to end of study (EOS) (Day 505)

  4. Number of Participants with Laboratory Abnormalities

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

Secondary outcomes

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

    Time frame: Days 1, 85, and 197

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

    Time frame: Days 1, 85, and 197

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

    Time frame: Days 1, 85, and 197

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

    Time frame: Days 1, 85, and 197

    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.

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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