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Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04232280
Recruitment Status : Recruiting
First Posted : January 18, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Study Description
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Brief Summary:
This clinical study will assess the safety and immunogenicity of 3 dose levels of mRNA-1647 cytomegalovirus vaccine in CMV-seronegative and CMV-seropositive healthy adults 18-40 years of age.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description: Observer-Blind
Primary Purpose: Prevention
Official Title: A Phase 2, Randomized, Observer-Blind, Placebo-Controlled, Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CMV-seronegative
Escalating dose levels
 Biological: mRNA-1647
Cytomegalovirus vaccine

Other: Placebo
Saline
Experimental: CMV-seropositive
Escalating dose levels
 Biological: mRNA-1647
Cytomegalovirus vaccine

Other: Placebo
Saline


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of solicited local and systemic adverse reactions (ARs) [ Time Frame: 7 days following each dose administration ]
  2. Frequency of unsolicited adverse events (AEs) [ Time Frame: 28 days following each dose administration ]
  3. Frequency of medically-attended adverse events (MAAEs) [ Time Frame: 6 months following the last dose administration ]
  4. Frequency of serious adverse events (SAEs) [ Time Frame: One year following the last dose administration ]
  5. Change in geometric mean titer (GMT) of serum neutralizing anti-CMV antibodies against epithelial cell infection and against fibroblast infection [ Time Frame: Up to Day 504 ]
  6. Percentage of participants with ≥ 2-fold, 3-fold, and 4-fold increases in neutralizing antibodies over baseline against epithelial cell infection and against fibroblast infection [ Time Frame: Up to Day 504 ]

Secondary Outcome Measures :
  1. GMT of anti-gB specific IgG and anti-Pentamer specific IgG as measured by enzyme-linked immunosorbent assay (ELISA), and associated GMR of post-baseline/baseline titers [ Time Frame: Day 1, 29, 56, 84, 168, 196, 336, and 504 ]
  2. GMT, GMR, and proportion of participants with ≥ 2-fold, 3-fold, and 4-fold increases over baseline of serum nAb against epithelial cell infection and against fibroblast infection [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]
  3. GMT and GMR of antigen-specific IgG (ELISA) in the CMV-seropositive group [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]
  4. GMT and GMR of antigen-specific IgG (ELISA) in the CMV-seronegative group [ Time Frame: Day 1, 29, 56, 84 , 168, 196, 336, and 504 ]

Eligibility Criteria
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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:   Yes
Criteria

Inclusion Criteria:

  • Male or female 18-40 years of age
  • 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
  • Body mass index (BMI) 18-35 kg/m2
  • Female subjects must either be of non-childbearing potential or use acceptable methods of contraception from at least 30 days prior to enrollment and through 3 months following last vaccination
  • Male subjects must agree to practice adequate contraception for 30 days prior to the first vaccination and through 3 months following the last vaccination

Exclusion Criteria:

  • Acutely ill or febrile on the day of the first vaccination
  • Prior receipt of any CMV vaccine
  • Abnormal screening safety laboratory test results
  • Diagnosis or condition that, in the judgment of Investigator, is clinically unstable or may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to trial procedures
  • Has received or plans to receive a vaccine ≤ 28 days prior to the first vaccination or plans to receive a non-study vaccine within 28 days prior to or after any study vaccination, except for any licensed influenza vaccine which can be administered > 14 days before or after any study vaccination
  • Prior receipt of chronic systemic immunosuppressants or immune-modifying drugs
  • Receipt of intravenous immunoglobulins or plasma products within 3 months prior to the day of the first study vaccination
  • Previous receipt of medications in lipid nanoparticle (LNP) formulation
  • Has donated ≥ 450 mL of blood products within 28 days of the Screening visit
  • Participated in an interventional clinical trial within 28 days prior to the day of enrollment
  • Is an immediate family member or household member of trial personnel
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): NCT04232280


Contacts
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Contact: Moderna Clinical Trials 855-663-6762 clinicaltrials@modernatx.com

Locations
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United States, California
Benchmark Research Recruiting
Sacramento, California, United States, 95864
United States, Illinois
Optimal Research Recruiting
Peoria, Illinois, United States, 61614
United States, Kansas
Johnson County Clin-Trials Recruiting
Lenexa, Kansas, United States, 66219
United States, Kentucky
Alliance for Multispecialty Research Recruiting
Lexington, Kentucky, United States, 40509
United States, Nebraska
Meridian Clinical Research Not yet recruiting
Norfolk, Nebraska, United States, 68701
United States, Oklahoma
Lynn Health Science Institute Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
United States, Texas
Tekton Research Inc Recruiting
Austin, Texas, United States, 78745
Benchmark Research Not yet recruiting
Fort Worth, Texas, United States, 76135
Crossroads Clinical Research Recruiting
Victoria, Texas, United States, 77901
United States, Utah
Tanner Clinic Not yet recruiting
Layton, Utah, United States, 84041
Foothill Family Clinic Recruiting
Salt Lake City, Utah, United States, 84109
Foothill Family Clinic-South Clinic Recruiting
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT04232280    
Other Study ID Numbers: mRNA-1647-P202
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
DNA Virus Infections
Messenger RNA
Additional relevant MeSH terms:
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Infection
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs