Epstein-Barr Virus Infection
Conditions
Keywords
Infectious mononucleosis, Mononucleosis
Brief 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
BIOLOGICALmRNA-1189
Sterile liquid for injection
BIOLOGICALPlacebo
0.9% sodium chloride (normal saline) injection
Sponsors
ModernaTX, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 176 (7-day follow-up after vaccination) |
| Number of Participants with Unsolicited Adverse Events (AEs) | Up to Day 197 (28-day follow-up after vaccination) |
| Number of Participants with SAEs, MAAEs, Any 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
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titer (GMT) of B-Cell Neutralizing Antibody (nAb) | Days 1, 85, and 197 | — |
| Geometric Mean Concentration (GMC) of 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 Seroresponse of B-Cell nAbs and Antigen-specific bAbs | 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. |
Countries
United States
Outcome results
None listed