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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.

Study Description
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Brief Summary:
The goal of this study is to assess the safety, tolerability and immunogenicity of mRNA-1769 in healthy adult participants.

Condition or disease Intervention/treatment Phase
Smallpox Mpox Biological: mRNA-1769 Other: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : August 15, 2023
Estimated Primary Completion Date : May 30, 2025
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: mRNA-1769 Dose A
Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
 Biological: mRNA-1769
Sterile liquid for injection
Experimental: mRNA-1769 Dose B
Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
 Biological: mRNA-1769
Sterile liquid for injection
Experimental: mRNA-1769 Dose C
Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
 Biological: mRNA-1769
Sterile liquid for injection
Placebo Comparator: Placebo
Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
 Other: Placebo
0.9% sodium chloride injection (normal saline)


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP [ Time Frame: Up to Day 57 ]
  3. Number of Participants with Medically-Attended AEs (MAAEs) [ Time Frame: Day 1 up to Day 395 ]
  4. Number of Participants with Adverse Events of Special Interest (AESIs) [ Time Frame: Day 1 up to Day 395 ]
  5. Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Day 1 up to Day 395 ]
  6. Number of Participants with AEs Leading to Study and/or Treatment Discontinuation [ Time Frame: Day 1 up to Day 395 ]

Secondary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT) [ Time Frame: Days 1 and 43 ]
  2. Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV [ Time Frame: Days 1 and 43 ]
  3. Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay [ Time Frame: Days 1, 29, 43, and 57 ]
  4. Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV [ Time Frame: Days 1, 29, 43, and 57 ]
  5. Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT) [ Time Frame: Days 1 and 43 ]
  6. Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus [ Time Frame: Days 1 and 43 ]
  7. Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay [ Time Frame: Days 1, 29, 43, and 57 ]
  8. Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus [ Time Frame: Days 1, 29, 43, and 57 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT05995275


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

Locations
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United Kingdom
Bradford Teaching Hospitals NHS Foundation Trust Recruiting
Bradford, United Kingdom, BD9 6RJ
University Hospitals Bristol and Weston NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS2 8DX
Lakeside Healthcare Research Recruiting
Corby, United Kingdom, NN17 2UR
University Hospitals of Leicester Recruiting
Leicester, United Kingdom, LE1 5WW
Liverpool University Hospitals NHS Foundation Trust Recruiting
Liverpool, United Kingdom, L7 8XP
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 4DG
University College London Hospitals Recruiting
London, United Kingdom, NW1 2PG
Royal Free London NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
Chelsea and Westminster Hospital NHS Foundation Trust Recruiting
London, United Kingdom, SW10 9NH
Medicines Evaluation Unit Recruiting
Manchester, United Kingdom, M23 9QZ
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) Recruiting
Oxford, United Kingdom, OX3 7LE
North Wales Clinical Research Facility Centre Recruiting
Wrexham, United Kingdom, LL13 7YP
Sponsors and Collaborators
ModernaTX, Inc.
More Information
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Responsible Party: ModernaTX, Inc.
ClinicalTrials.gov Identifier: NCT05995275    
Other Study ID Numbers: mRNA-1769-P101
First Posted: August 16, 2023    Key Record Dates
Last Update Posted: March 13, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ModernaTX, Inc.:
mRNA-1769 vaccine
mRNA-1769
Moderna
Additional relevant MeSH terms:
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Smallpox
Poxviridae Infections
DNA Virus Infections
Virus Diseases
Infections