The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
351
Bradford Teaching Hospitals NHS Foundation Trust
Bradford, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom
Lakeside Healthcare Research
Corby, United Kingdom
Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
Time frame: Up to Day 35
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
Time frame: Up to Day 57
Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Day 1 up to Day 395
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 up to Day 395
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 up to Day 395
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
Time frame: Day 1 up to Day 395
Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
Time frame: Days 1 and 43
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
Time frame: Days 1 and 43
Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
Time frame: Days 1, 29, 43, and 57
Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV
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University Hospitals of Leicester
Leicester, United Kingdom
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust
London, United Kingdom
University College London Hospitals
London, United Kingdom
Royal Free London NHS Foundation Trust
London, United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, United Kingdom
Medicines Evaluation Unit
Manchester, United Kingdom
...and 2 more locations
Time frame: Days 1, 29, 43, and 57
Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)
Time frame: Days 1 and 43
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus
Time frame: Days 1 and 43
Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay
Time frame: Days 1, 29, 43, and 57
Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus
Time frame: Days 1, 29, 43, and 57