A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189, in 18- to 30-Year-Old Healthy Adults
Study Details
Study Description
Brief Summary
The main objective of this trial is to evaluate the safety and reactogenicity of mRNA-1189 in 18- to 30-year-old healthy adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: mRNA-1189 Dose Level 1 Participants will receive 3 intramuscular (IM) injections of mRNA-1189 at Dose Level 1 on Days 1, 57, and 169. |
Biological: mRNA-1189
Sterile liquid for injection
|
| Experimental: mRNA-1189 Dose Level 2 Participants will receive 3 IM injections of mRNA-1189 at Dose Level 2 on Days 1, 57, and 169. |
Biological: mRNA-1189
Sterile liquid for injection
|
| Experimental: mRNA-1189 Dose Level 3 Participants will receive 3 IM injections of mRNA-1189 at Dose Level 3 on Days 1, 57, and 169. |
Biological: mRNA-1189
Sterile liquid for injection
|
| Placebo Comparator: Placebo Participants will receive 1 IM injection of study drug-matching placebo on Days 1, 57, and 169. |
Biological: Placebo
0.9% sodium chloride (normal saline) injection
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) [Up to Day 176]
- Number of Participants with Unsolicited Adverse Events (AEs) [Up to Day 197 (28-day follow-up after vaccination)]
- 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)]
- Number of Participants with Laboratory Abnormalities [Up to Day 176 (7-day follow-up after vaccination)]
Secondary Outcome Measures
- Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) and/or Antigen-Specific Binding Antibody (bAb) [Days 1, 85, and 197]
- Geometric Mean Fold Rise (GMFR) of B-Cell nAb and Antigen-Specific bAb [Days 1, 85, and 197]
- Number of Participants With Seroconversion of B-Cell nAbs and/or Antigen-Specific bAbs [Days 1, 85, and 197]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Body mass index (BMI) of 18 kilograms (kg)/square meter (m2) to 35 kg/m2 (inclusive) at the screening visit (Day 0).
-
According to the assessment of the investigator, is in good general health and can comply with study procedures.
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).
-
Has a medical, psychiatric, or occupational condition that may pose additional risk as a result of participation, or that could interfere with safety assessments or interpretation of results according to the investigator's judgment.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Centers of America - ERG | Hollywood | Florida | United States | 33024 |
| 2 | Meridian Clinical Research-(Savannah Georgia) - Platinum - PPDS | Savannah | Georgia | United States | 31406 |
| 3 | Meridian Clinical Research, LLC | Sioux City | Iowa | United States | 51106 |
| 4 | Johnson County Clin-Trials | Lenexa | Kansas | United States | 66219 |
| 5 | UMass Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 6 | Meridian Clinical Research (Grand Island, Nebraska) | Grand Island | Nebraska | United States | 68803 |
| 7 | Meridian Clinical Research (Norfolk-Nebraska) - Platinum - PPDS | Norfolk | Nebraska | United States | 68701 |
| 8 | Meridian Clinical Research-(Omaha Nebraska) - Platinum - PPDS | Omaha | Nebraska | United States | 68134 |
| 9 | Meridian Clinical Research, LLC (Lincoln Nebraska) | Omaha | Nebraska | United States | 68510 |
| 10 | Meridian Clinical Research | Binghamton | New York | United States | 13901 |
| 11 | Meridian Clinical Research | Endwell | New York | United States | 13760 |
| 12 | Meridian Clinical Research | Cincinnati | Ohio | United States | 45219 |
| 13 | Coastal Carolina Research Center | North Charleston | South Carolina | United States | 29405 |
| 14 | Benchmark Research - Austin - PPDS | Austin | Texas | United States | 78705 |
| 15 | Tekton Research - Texas - Platinum - PPDS | Austin | Texas | United States | 78745 |
| 16 | DM Clinical Research - Texas Center For Drug Development - ERN - PPDS | Houston | Texas | United States | 77081 |
Sponsors and Collaborators
- ModernaTX, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- mRNA-1189-P101