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

Primary Purpose

Cytomegalovirus Infection

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mRNA-1647
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Optimal Research, LLC
  • Johnson County Clin-Trials, Inc.
  • Alliance for Multispeciality Research, LLC
  • Tekton Research Inc
  • Crossroads Clinical Research (Victoria)
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • J. Lewis Research, Inc. / Foothill Family Clinic South

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CMV-seropositive and CMV-seronegative Participants

Arm Description

CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With Adverse Events (AEs) Leading to Study Discontinuation
Number of Participants With Serious Adverse Events (SAEs)
Number of Participants who Died

Full Information

First Posted
July 9, 2021
Last Updated
June 5, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04975893
Brief Title
A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine
Official Title
A Phase 2, Non-Randomized, Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus mRNA-1647 Vaccine in Participants Who Completed Study mRNA-1647-P202
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
December 30, 2025 (Anticipated)
Study Completion Date
December 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main purpose 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).
Detailed Description
The study aims to explore the long-term potential differences in immunogenicity and key safety parameters following mRNA-1647 administration in CMV-seronegative and CMV-seropositive participants. Study mRNA-1647-P202 participants 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 this extension study. Eligible participants enrolling in the extension study 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Moderna, mRNA-1647, Cytomegalovirus, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Diseases, Infection Viral, DNA Virus Infections, Messenger RNA

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
291 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CMV-seropositive and CMV-seronegative Participants
Arm Type
Other
Arm Description
CMV-seropositive and CMV-seronegative participants who completed Study mRNA-1647-P202 will be followed every 6 months for 3 years in this study after the final visit in Study mRNA-1647-P202.
Intervention Type
Biological
Intervention Name(s)
mRNA-1647
Intervention Description
No investigational product will be administered in this extension study.
Primary Outcome Measure Information:
Title
Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb)
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) Leading to Study Discontinuation
Time Frame
Up to 3 years
Title
Number of Participants With Serious Adverse Events (SAEs)
Time Frame
Up to 3 years
Title
Number of Participants who Died
Time Frame
Up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Optimal Research, LLC
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61610
Country
United States
Facility Name
Johnson County Clin-Trials, Inc.
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
Alliance for Multispeciality Research, LLC
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Tekton Research Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Crossroads Clinical Research (Victoria)
City
Victoria
State/Province
Texas
ZIP/Postal Code
77901
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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