mRNA-1189
BiologicalSterile liquid for injection
NCT Number: NCT05164094
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.
This study is active but is not currently recruiting participants.
Notify Me10 year–30 year
All sexes
Interventional
Phase 1 / Phase 2
Medical Affiliated Research Institute, Huntsville, Alabama, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Note: Other inclusion and exclusion criteria may apply.
Sterile liquid for injection
0.9% sodium chloride (normal saline) injection
Time frame: Up to Day 176 (7-day follow-up after vaccination)
Time frame: Up to Day 197 (28-day follow-up after vaccination)
Time frame: Day 1 to end of study (EOS) (Day 505)
Time frame: Up to Day 176 (7-day follow-up after vaccination)
Time frame: Days 1, 85, and 197
Time frame: Days 1, 85, and 197
Time frame: Days 1, 85, and 197
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.
ModernaTX, Inc.
Industry
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
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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