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

Cytomegalovirus Infection Clinical Trial

Official title:

A Phase 2, Non-Randomized, Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus mRNA-1647 Vaccine Including a Booster Dose in a Subset of Participants Who Completed Study mRNA-1647-P202

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04975893
• Other study ID #: mRNA-1647-P202-EXT
• Status: Enrolling by invitation
• Phase: Phase 2
• Start date: June 18, 2021
• Est. completion date: December 30, 2026

Study information

• Verified date: February 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 291
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

Primary Extension Phase:

• Male or 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/exclusion criteria apply

Related Conditions & MeSH terms

• Cytomegalovirus Infection
• Cytomegalovirus Infections
• Infections

Intervention

Biological:
• mRNA-1647
No investigational product will be administered during the Primary Extension Phase or to the participants in the Observational Group.

Other:
• mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Locations

Country	Name	City	State
United States	Tekton Research Inc	Austin	Texas
United States	Johnson County Clin-Trials, Inc.	Lenexa	Kansas
United States	Alliance for Multispeciality Research, LLC	Lexington	Kentucky
United States	Optimal Research, LLC	Peoria	Illinois
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	Crossroads Clinical Research (Victoria)	Victoria	Texas

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Extension Phase: Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)		Up to 3 years
Primary	BP: GMTs of Antigen-Specific nAb and bAb		BP Month 0, BP Month 1, BP Month 3, BP Month 6, and BP Month 12
Primary	BP: Number of Participants with Solicited Adverse Reactions (ARs)		Up to BP Day 7 (7 days after BP vaccination)
Primary	BP: Number of Participants with Unsolicited Adverse Events (AEs)		Up to BP Day 28 (28 days after BP vaccination)
Primary	BP: Number of Participants with Medically-Attended AEs (MAAEs)		Up to BP Month 6 (6 months after BP vaccination)
Primary	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
Secondary	Primary Extension Phase: Number of Participants With AEs Leading to Study Discontinuation		Up to 3 years
Secondary	Primary Extension Phase: Number of Participants With SAEs		Up to 3 years