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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04975893
Recruitment Status : Enrolling by invitation
First Posted : July 26, 2021
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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).

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Biological: mRNA-1647 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 291 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : June 18, 2021
Estimated Primary Completion Date : December 30, 2025
Estimated Study Completion Date : December 30, 2025


Arm Intervention/treatment
CMV-seropositive and CMV-seronegative Participants
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.
Biological: mRNA-1647
No investigational product will be administered in this extension study.




Primary Outcome Measures :
  1. Geometric Mean Titers (GMTs) of Antigen-Specific Neutralizing Antibody (nAb) and Binding Antibody (bAb) [ Time Frame: Up to 3 years ]

Secondary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) Leading to Study Discontinuation [ Time Frame: Up to 3 years ]
  2. Number of Participants With Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]
  3. Number of Participants who Died [ Time Frame: Up to 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04975893


Locations
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United States, Illinois
Optimal Research, LLC
Peoria, Illinois, United States, 61610
United States, Kansas
Johnson County Clin-Trials, Inc.
Lenexa, Kansas, United States, 66219
United States, Kentucky
Alliance for Multispeciality Research, LLC
Lexington, Kentucky, United States, 40509
United States, Texas
Tekton Research Inc
Austin, Texas, United States, 78745
Crossroads Clinical Research (Victoria)
Victoria, Texas, United States, 77901
United States, Utah
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84109
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
ModernaTX, Inc.
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04975893    
Other Study ID Numbers: mRNA-1647-P202-EXT
First Posted: July 26, 2021    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1647
CMV
Cytomegalovirus Infections
Moderna
Cytomegalovirus
Cytomegalovirus Vaccine
Cytomegalovirus Congenital
Virus Diseases
Infection Viral
DNA Virus Infections
Messenger RNA
Additional relevant MeSH terms:
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Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases