CompletedPhase 2

A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine

United States135 participantsStarted 2021-06-18

Plain-language summary

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.

Who can participate

Age range18 Years – 40 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Primary Extension Phase: * Male and female participants who were CMV-seronegative at the Study mRNA-1647-P202 Screening visit, completed the final Study mRNA-1647-P202 visit, and remained CMV-seronegative at Screening for Study mRNA-1647-P202-EXT. * Male and female participants who were CMV-seropositive at the Study mRNA-1647-P202 Screening visit, were randomized to receive mRNA-1647 injection (and not placebo), and completed the final visit in Study mRNA-1647-P202. * Understands and agrees to comply with the trial procedures and provides written informed consent. * According to the assessment of the Investigator, is in good general health and is capable of complying with trial procedures. Optional Booster Phase: For BD Recipients: \- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 medium dose injection (and not placebo or other dose levels) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P202-EXT and participants who were eligible but did not previously enroll in the Primary Extension Phase of Study mRNA-1647-P202-EXT are eligible to receive a BD in the optional BP. For Observational Group: \- CMV-seronegative and CMV-seropositive participants who received mRNA-1647 low dose or high dose injection (and not placebo or mRNA-1647 medium dose injection) in Study mRNA-1647-P202, including participants who enrolled in the Primary Extension Phase of Study mRNA-1647-P2…

What they're measuring

Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)

Timeframe: Up to 3 years

BP: GMTs of Antigen-Specific nAb and bAb

Timeframe: 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)

Timeframe: Up to BP Day 7 (7 days after BP vaccination)

BP: Number of Participants with Unsolicited Adverse Events (AEs)

Timeframe: Up to BP Day 28 (28 days after BP vaccination)

BP: Number of Participants with Medically-Attended AEs (MAAEs)

Timeframe: 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

Timeframe: Up to BP Month 12

Trial details

NCT IDNCT04975893

SponsorModernaTX, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-01-19

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