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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 : Recruiting
First Posted : January 18, 2020
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE December 23, 2019
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • Frequency of Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 175 (7 days following last dose administration) ]
  • Frequency of Unsolicited Adverse Events (AEs) [ Time Frame: Up to Day 196 (28 days following last dose administration) ]
  • Frequency of Medically-Attended Adverse Events (MAAEs) [ Time Frame: Up to Day 336 (6 months following last dose administration) ]
  • Frequency of Serious Adverse Events (SAEs) [ Time Frame: Up to Day 504 (1 year following last dose administration) ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Frequency of Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: 7 days following each dose administration ]
  • Frequency of Unsolicited Adverse Events (AEs) [ Time Frame: 28 days following each dose administration ]
  • Frequency of Medically-Attended Adverse Events (MAAEs) [ Time Frame: 6 months following the last dose administration ]
  • Frequency of Serious Adverse Events (SAEs) [ Time Frame: One year following the last dose administration ]
  • 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 ]
  • 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 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2021)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose-Finding Trial to Evaluate the Safety and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 in Healthy Adults
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Observer-Blind
Primary Purpose: Prevention
Condition  ICMJE Cytomegalovirus Infection
Intervention  ICMJE
  • Biological: mRNA-1647
    Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
  • Other: Placebo
    0.9% sodium chloride (normal saline) injection
Study Arms  ICMJE
  • 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.
    Intervention: Biological: mRNA-1647
  • 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.
    Intervention: Biological: mRNA-1647
  • 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.
    Intervention: Biological: mRNA-1647
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 17, 2020)
452
Original Estimated Enrollment  ICMJE
 (submitted: January 14, 2020)
252
Estimated Study Completion Date  ICMJE May 31, 2022
Estimated Primary Completion Date May 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials 877-913-3286 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04232280
Other Study ID Numbers  ICMJE mRNA-1647-P202
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party ModernaTX, Inc.
Study Sponsor  ICMJE ModernaTX, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP