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Trial record 1 of 1 for:    mRNA-1769
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A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age

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ClinicalTrials.gov Identifier: NCT05995275
Recruitment Status : Recruiting
First Posted : August 16, 2023
Last Update Posted : March 13, 2024
Sponsor:
Information provided by (Responsible Party):
ModernaTX, Inc.

Tracking Information
First Submitted Date  ICMJE August 9, 2023
First Posted Date  ICMJE August 16, 2023
Last Update Posted Date March 13, 2024
Actual Study Start Date  ICMJE August 15, 2023
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 9, 2023)
  • Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP) [ Time Frame: Up to Day 35 ]
  • Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP [ Time Frame: Up to Day 57 ]
  • Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Day 1 up to Day 395 ]
  • Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 up to Day 395 ]
  • Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 395 ]
  • Number of Participants with AEs Leading to Study and/or Treatment Discontinuation [ Time Frame: Day 1 up to Day 395 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 9, 2023)
  • Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT) [ Time Frame: Days 1 and 43 ]
  • Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV [ Time Frame: Days 1 and 43 ]
  • Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay [ Time Frame: Days 1, 29, 43, and 57 ]
  • Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV [ Time Frame: Days 1, 29, 43, and 57 ]
  • Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT) [ Time Frame: Days 1 and 43 ]
  • Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus [ Time Frame: Days 1 and 43 ]
  • Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay [ Time Frame: Days 1, 29, 43, and 57 ]
  • Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus [ Time Frame: Days 1, 29, 43, and 57 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Investigate The Safety, Tolerability, And Immune Response of a Range of Doses of mRNA-1769 Compared With Placebo in Healthy Participants From ≥18 Years of Age to <50 Years of Age
Official Title  ICMJE A Randomised, Placebo-Controlled, Dose-Ranging, Observer-Blind Phase 1/2 Study to Evaluate the Safety, Tolerability, and Immunogenicity of mRNA-1769 in Healthy Participants
Brief Summary The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Smallpox
  • Mpox
Intervention  ICMJE
  • Biological: mRNA-1769
    Sterile liquid for injection
  • Other: Placebo
    0.9% sodium chloride injection (normal saline)
Study Arms  ICMJE
  • Experimental: mRNA-1769 Dose A
    Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
    Intervention: Biological: mRNA-1769
  • Experimental: mRNA-1769 Dose B
    Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
    Intervention: Biological: mRNA-1769
  • Experimental: mRNA-1769 Dose C
    Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
    Intervention: Biological: mRNA-1769
  • Placebo Comparator: Placebo
    Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
    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: August 9, 2023)		 350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2025
Estimated Primary Completion Date May 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has a body mass index (BMI) between ≥18 kilogram per square meter (kg/m^2) to ≤39 kg/m^2.
  • For female participants of childbearing potential: must have a negative highly sensitive pregnancy test with 28 days before the first dose of study drug, uses approved contraception during the study intervention period and for at least 3 months after the last dose of study drug, and not currently breastfeeding.

Exclusion Criteria:

  • History of smallpox vaccination, vaccination with any poxvirus-based vaccine, history of of/or recent exposure to Mpox (MPX) (defined as close contact with a confirmed case of MPX within the past 14 days).
  • Participant should not have any significant, progressive, unstable, or uncontrolled clinical condition, including any condition that may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures per Investigator judgement.
  • Participant is undergoing investigations for a potential chronic medical disorder.
  • Bleeding disorder considered a contraindication to IM injection or phlebotomy.
  • Dermatologic conditions that could affect local solicited AR assessments.
  • History of anaphylactic reaction or allergic reactions that required medical intervention following any vaccine.
  • Known or suspected allergy to any component of mRNA-1769.
  • History of malignancy within previous 10 years (excluding non-melanoma skin cancer).
  • Participant has any medical, psychiatric, or occupational condition, including reported history of drug or alcohol abuse, 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.
  • Participant has received systemic immunosuppressants or immune-modifying drugs for >14 days in total within 6 months prior to Screening (for corticosteroids, ≥10 mg/day of prednisone or equivalent) or is anticipating the need for immunosuppressive treatment at any time during participation in the study. Topical tacrolimus is allowed if not used within 14 days prior to the day of enrolment. Participants may be rescheduled for enrolment if they no longer meet this criterion within the Screening Period. Inhaled, nasal, and topical steroids are allowed.
  • Receipt or planned receipt of: Any vaccine(s), authorised or approved by local health agency, including mRNA vaccine, ≤28 days prior to the first injection through 28 days after the last dose of investigational (IMP).
  • Intravenous blood products (red cells, platelets, immunoglobulins) within 3 months prior to the first injection up to the end of the study.
  • Participated in an interventional study/received an investigational product within 28 days prior to the Screening Period or plans to do so while enroled in this study.

Note: Other inclusion and exclusion criteria may apply.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Moderna Clinical Trials Support Center 1-877-777-7187 clinicaltrials@modernatx.com
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05995275
Other Study ID Numbers  ICMJE mRNA-1769-P101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party ModernaTX, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE ModernaTX, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account ModernaTX, Inc.
Verification Date March 2024

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