Cytomegalovirus Infection
Conditions
Keywords
Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALmRNA-1647
No investigational product will be administered during the Primary Extension Phase or to the participants in the Observational Group.
Sponsors
ModernaTX, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
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-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 enroll in the observational group.
Exclusion criteria
Primary Extension Phase: * Receipt of any CMV vaccine other than mRNA-1647. * Diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures, including any medical, psychiatric, or occupational condition that, in the opinion of the Investigator, might pose additional risk due to participation in the study or could interfere with the interpretation of study results. Optional Booster Phase: For BD Recipients: \- Participants from the placebo, mRNA-1647 low dose, or mRNA-1647 medium dose groups in Study mRNA-1647-P202. For Observational Group: \- Participants from the placebo or mRNA-1647 medium dose groups in study mRNA-1647-P202. Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| BP: Number of Participants with Adverse Events of Special Interest (AESIs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation of Study | Up to BP Month 12 |
| Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb) | Up to 3 years |
| BP: GMTs of Antigen-Specific nAb and bAb | 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) | Up to BP Day 7 (7 days after BP vaccination) |
| BP: Number of Participants with Unsolicited Adverse Events (AEs) | Up to BP Day 28 (28 days after BP vaccination) |
| BP: Number of Participants with Medically-Attended AEs (MAAEs) | Up to BP Month 6 (6 months after BP vaccination) |
Secondary
| Measure | Time frame |
|---|---|
| Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation | Up to 3 years |
| Primary Extension Phase: Number of Participants With SAEs | Up to 3 years |
Countries
United States
Outcome results
None listed