Skip to main content
OpenTrials
Completed

NCT Number: NCT05995275

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA-1769

Biological

Sterile liquid for injection

Placebo

Other

0.9% sodium chloride injection (normal saline)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2023
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.