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A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647

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ClinicalTrials.gov Identifier: NCT05105048
Recruitment Status : Recruiting
First Posted : November 3, 2021
Last Update Posted : March 10, 2022
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
The main objective of this study is to evaluate the safety, reactogenicity, and immunogenicity of the mRNA-1647 vaccine administered according to a 3-study injection schedule in healthy cytomegalovirus (CMV)-seronegative and CMV-seropositive Japanese adults 18 to 40 years of age in the United States.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infection Biological: mRNA-1647 Biological: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 When Administered to Healthy Japanese Adults (18-40 Years of Age) in the United States
Actual Study Start Date : November 8, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1647
CMV-seronegative or CMV-seropositive participants will receive mRNA-1647 vaccine by intramuscular (IM) injection in a 0-, 2-, and 6-month schedule.
 Biological: mRNA-1647
Lyophilized product that is reconstituted with saline
Placebo Comparator: Placebo
CMV-seronegative or CMV-seropositive participants will receive placebo matching to mRNA-1647 vaccine by IM injection in a 0-, 2-, and 6-month schedule.
 Biological: Placebo
0.9% sodium chloride (normal saline) injection


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 176 (7 days after each injection) ]
  2. Number of Participants With Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 197 (28 days after each injection) ]
  3. Number of Participants With Medically-Attended AEs (MAAEs) [ Time Frame: Day 1 through 6 months after the last injection (up to Day 347) ]
  4. Number of Participants With Serious AEs (SAEs) [ Time Frame: Day 1 through End of Study (EOS) (up to Day 347) ]
  5. Number of Participants With AEs of Special Interest (AESIs) [ Time Frame: Day 1 through EOS (up to Day 347) ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies (nAbs) Against Epithelial Cell Infection and Against Fibroblast Infection [ Time Frame: Days 1, 29, 85, 169, 197, and 347 ]
  2. Geometric Mean Fold-Rise (GMFR) of nAb Against Epithelial Cell Infection and Against Fibroblast Infection [ Time Frame: Days 29, 85, 169, 197, and 347 ]
  3. Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in nAb over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection [ Time Frame: Days 29, 85, 169, 197, and 347 ]
  4. GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) [ Time Frame: Days 1, 29, 85, 169, 197, and 347 ]
  5. GMFR of Anti-gB and Anti-Pentamer Specific IgG [ Time Frame: Days 29, 85, 169, 197, and 347 ]
  6. Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases Over Baseline in Anti-gB and Anti-Pentamer Specific IgG [ Time Frame: Days 29, 85, 169, 197, and 347 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participant is a Japanese Adult 18-40 years of age at the time of consent who, in the opinion of the investigator, is in good health based on review of medical history and screening physical examination. Japanese participants are defined as individuals born in Japan, with both parents and 4 grandparents who were born in Japan, and who have not lived outside of Japan for more than 10 years in total.
  • For the CMV-seronegative groups: Participant is serum CMV IgG negative/ IgM negative.
  • For the CMV-seropositive groups: Participant is either serum CMV IgG positive/IgM negative or IgG positive/IgM positive.
  • Participant has a body mass index (BMI) from ≥18 kilograms (kg)/square meter (m^2) to ≤35 kg/m^2, inclusive.

Exclusion Criteria:

  • History of a diagnosis or condition that, in the judgment of the investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. Clinically unstable is defined as a diagnosis or condition requiring significant changes in management or medication within the 2 months prior to screening and includes ongoing workup of an undiagnosed illness that could lead to a new diagnosis or condition.
  • Participant has elevated liver function tests, defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP), or elevated creatinine or reduced platelets, with a toxicity score of Grade ≥1 at screening.
  • Participant has laboratory test results (hematology, chemistry, and coagulation) with a toxicity score of Grade ≥1 at screening.

  • Received or plans to receive any non-study vaccine <28 days prior to any study injection; in addition, the following criteria for COVID-19 and influenza vaccines apply:

    i. Any COVID-19 vaccination series must have been completed a minimum of 28 days prior to receiving any dose of the study injection.

ii. COVID-19 vaccines (regardless of manufacturer) must be administered at least 28 days prior to or after any study injection.

iii. Influenza vaccines may be administered >14 days prior to or after any study injection.

  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months before the day of first injection (Day 1) (for corticosteroids, >5 mg/day of prednisone equivalent) or plans to do so during the course of the study. Inhaled, nasal, and topical steroids are allowed.
  • Participant has received an antiviral with activity against CMV (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir, acyclovir, valacyclovir) within 2 weeks before the first injection or plans to do so during the course of the study.
  • Participant received any investigational CMV vaccine.
  • History of myocarditis, pericarditis, or myopericarditis.
  • Reported medical history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV); or a positive screening test for hepatitis B surface antigen (HbSAg), hepatitis C antibodies, or HIV 1 or 2 antibodies.

Other inclusion and exclusion criteria may apply.

Contacts and Locations
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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): NCT05105048


Contacts
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Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com

Locations
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United States, California
Velocity Clinical Research Recruiting
North Hollywood, California, United States, 91606
California Research Foundation Recruiting
San Diego, California, United States, 92123
United States, Hawaii
East-West Medical Research Institute Recruiting
Honolulu, Hawaii, United States, 96814
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05105048    
Other Study ID Numbers: mRNA-1647-P103
First Posted: November 3, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 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.:
Moderna
mRNA-1647
Cytomegalovirus
CMV
Cytomegalovirus Vaccine
 Cytomegalovirus Infections
Cytomegalovirus Congenital
Virus Diseases
Infection Viral
Messenger RNA
Additional relevant MeSH terms:
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Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases