The purpose of this first-in-human study is to evaluate the safety and immunogenicity of mRNA-1468.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
659
Velocity Clinical Research - Westlake
Los Angeles, California, United States
Tekton Research, Inc - Longmont Center
Number Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions
Time frame: Up to Day 64 (7 days after each injection)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 85 (28 days after each injection)
Number of Participants with Serious AEs, AEs Leading to Discontinuation of Study Vaccine or Withdrawal From the Study, and AEs of Special Interest
Time frame: Day 1 to End of Study (up to a maximum of Day 1113)
Number of Participants with Medically Attended AEs
Time frame: Day 1 to Day 393 (12 months after last study injection)
Vaccine Seroresponse Rate of Participants
Vaccine seroresponse will be defined as an anti-glycoprotein E (gE)-specific binding antibody (bAb) concentration ≥4-fold if baseline bAb concentration is above the lower limit of quantification (LLOQ) or ≥4 \* LLOQ if baseline bAb concentration is \<LLOQ prior to vaccination.
Time frame: Day 85 and Day 225 (1 and 6 months after the last injection)
Geometric Mean Concentration of Anti-gE-specific bAb as Measured by Enzyme-linked Immunosorbent Assay
Time frame: Day 85 and Day 225 (1 and 6 months after the last injection)
Change from Baseline in Geometric Mean Fold Rise of Anti-gE-specific bAb Concentration
Time frame: Baseline, Day 85 and Day 225 (1 and 6 months after the last injection)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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