The main purpose of the extension phase of this study is to evaluate the longer-term immune persistence of mRNA-1647 vaccine administered to CMV-seronegative and CMV-seropositive adults who completed Study mRNA-1647-P202 (NCT04232280). For participants in the optional booster phase (BP), the main purpose is to evaluate the long-term immunogenicity and safety of the mRNA-1647 vaccine in both participants receiving a booster dose (BD) and those not receiving a BD, and to additionally evaluate the reactogenicity in participants receiving a BD.
The study aims to explore the long-term potential differences in immunogenicity and key safety parameters following mRNA-1647 administration, participants who completed study mRNA-1647-P202, who are CMV-seronegative and who did not seroconvert due to primary CMV infection during the study will be enrolled. Study mRNA-1647-P202 participants who were CMV-seropositive at baseline, randomized to receive mRNA-1647 injection, and completed their final study visit will also be enrolled. No study treatment will be administered during the primary extension phase of this study. Eligible participants enrolling in the primary extension phase who completed Study mRNA-1647-P202 may have received mRNA-1647 (either low dose, medium dose, or high dose) or placebo in CMV-seronegative participants and mRNA-1647 (either low dose, medium dose, or high dose) in CMV-seropositive participants. In the optional BP, consenting and eligible participants will receive a single BD of the mRNA-1647 vaccine (medium dose). In the Observational Group of the optional BP, consenting and eligible participants will not receive study treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
135
Optimal Research, LLC
Peoria, Illinois, United States
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States
Alliance for Multispeciality Research, LLC
Lexington, Kentucky, United States
Tekton Research Inc
Austin, Texas, United States
Crossroads Clinical Research (Victoria)
Victoria, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)
Time frame: Up to 3 years
BP: GMTs of Antigen-Specific nAb and bAb
Time frame: BP Month 0, BP Month 1, BP Month 3, BP Month 6, and BP Month 12
BP: Number of Participants with Solicited Adverse Reactions (ARs)
Time frame: Up to BP Day 7 (7 days after BP vaccination)
BP: Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to BP Day 28 (28 days after BP vaccination)
BP: Number of Participants with Medically-Attended AEs (MAAEs)
Time frame: Up to BP Month 6 (6 months after BP vaccination)
BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study
Time frame: Up to BP Month 12
Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation
Time frame: Up to 3 years
Primary Extension Phase: Number of Participants With SAEs
Time frame: Up to 3 years
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