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

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ClinicalTrials.gov Identifier: NCT04232280
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : October 11, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

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

Detailed Description:
mRNA-1647-P202 is a 2-part study. Part 1 of the study evaluates the safety and immunogenicity of low, medium, and high dose levels of mRNA-1647 vaccine or placebo, administered on a 0, 2, 6-month schedule in healthy CMV-seronegative and CMV-seropositive males and females, 18 to 40 years of age. A planned interim analysis of safety and immunogenicity through Month 3 (1 month after the second dose) of Part 1 of the study informed the selection of the middle dose level for further development. Part 2 of the study is designed to further evaluate the safety and immunogenicity of the middle dose level of mRNA-1647 vaccine or placebo on a 0, 2, 6-month schedule in approximately 200 healthy participants 18 to 40 years of age, comprised of CMV-seronegative and CMV-seropositive female population, which includes the target population for the pivotal Phase 3 efficacy trial.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 315 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 : January 9, 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: mRNA-1647 Low Dose
Participants will receive mRNA-1647 vaccine at the Low Dose by intramuscular (IM) injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Experimental: mRNA-1647 Medium Dose
Participants will receive mRNA-1647 vaccine at the Medium Dose by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Experimental: mRNA-1647 High Dose
Participants will receive mRNA-1647 vaccine at the High Dose by IM injection on Day 1, Day 56, and Day 168.
Biological: mRNA-1647
Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration

Placebo Comparator: Placebo
Participants will receive placebo matching to the mRNA-1647 vaccine dose by IM injection on Day 1, Day 56, and Day 168.
Other: Placebo
0.9% sodium chloride (normal saline) injection




Primary Outcome Measures :
  1. Frequency of Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 175 (7 days following last dose administration) ]
  2. Frequency of Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 196 (28 days following last dose administration) ]
  3. Frequency of Medically-Attended Adverse Events (MAAEs) [ Time Frame: Up to Day 336 (6 months following last dose administration) ]
  4. Frequency of Serious Adverse Events (SAEs) [ Time Frame: Up to Day 504 (1 year following last dose administration) ]
  5. Change from Baseline in Geometric Mean Titer (GMT) of Serum Neutralizing Anti-CMV Antibodies Against Epithelial Cell Infection and Against Fibroblast Infection [ Time Frame: Baseline, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  6. Proportion of Participants with ≥2-Fold, 3-Fold, and 4-Fold Increases in Neutralizing Antibodies (nAb) over Baseline Against Epithelial Cell Infection and Against Fibroblast Infection [ Time Frame: Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504 ]

Secondary Outcome Measures :
  1. Change from Baseline in GMT of Anti-Glycoprotein B (gB) Specific Immunoglobulin G (IgG) and Anti-Pentamer Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) of Post-Baseline/Baseline Titers [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  2. Change from Baseline in Associated GMR of Anti-gB Specific IgG and Anti-Pentamer Specific IgG as Measured by ELISA of Post-Baseline/Baseline Titers [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  3. Change from Baseline in GMT of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  4. Change from Baseline in GMR of Serum nAb Against Epithelial Cell Infection and Against Fibroblast Infection at Each Timepoint, in the CMV-Seropositive Group and in the CMV-Seronegative Group [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  5. 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, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, and Day 504 ]
  6. Change from Baseline in GMT of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]
  7. Change from Baseline in GMR of Antigen-Specific IgG (ELISA) at each Timepoint in the CMV-Seropositive and CMV-Seronegative Groups [ Time Frame: Baseline, Day 1, Day 29, Day 56, Day 84, Day 168, Day 196, Day 336, Day 504 ]


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 (Part 1); Female 18-40 years of age (Part 2)
  • 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 kilograms/meter (kg/m^2)
  • Female participants must either be of non-childbearing potential or use acceptable methods of contraception from at least 28 days prior to the first vaccination and through 3 months following last vaccination and is not breastfeeding.
  • Male participants must agree to practice adequate contraception from the time of the first vaccination and through 3 months after 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. COVID-19 vaccines (regardless of manufacturer) may be administered >7 days but preferably >14 days before or after any study vaccination, with the intention of prioritizing COVID-19 vaccination over all other considerations.
  • 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 (Part 1 participants only)
  • Has donated ≥450 milliliters (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

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


Locations
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United States, California
Benchmark Research
Sacramento, California, United States, 95864
United States, Illinois
Optimal Research
Peoria, Illinois, United States, 61614
United States, Kansas
Johnson County Clin-Trials
Lenexa, Kansas, United States, 66219
United States, Kentucky
Alliance for Multispecialty Research
Lexington, Kentucky, United States, 40509
United States, Ohio
Aventiv Research Inc
Columbus, Ohio, United States, 43213-6523
United States, Texas
Tekton Research Inc
Austin, Texas, United States, 78745
Crossroads Clinical Research
Victoria, Texas, United States, 77901
United States, Utah
Foothill Family Clinic
Salt Lake City, Utah, United States, 84109
Foothill Family Clinic-South Clinic
Salt Lake City, Utah, United States, 84121
Sponsors and Collaborators
ModernaTX, Inc.
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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: October 11, 2021
Last Verified: October 2021
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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Infections
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases