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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 | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT05995275•ModernaTX, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

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.
+3 more criteria

Locations (12)

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

Lakeside Healthcare Research

Corby, United Kingdom

University Hospitals of Leicester

Leicester, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust

London, United Kingdom

University College London Hospitals

London, United Kingdom

Royal Free London NHS Foundation Trust

London, United Kingdom

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

Medicines Evaluation Unit

Manchester, United Kingdom

Key Dates

Start Date

August 15, 2023

Primary Completion Date

July 8, 2025

Completion Date

July 8, 2025

Last Updated

July 16, 2025

Enrollment

351

ACTUAL participants

Conditions

SmallpoxMpox

Interventions

mRNA-1769

BIOLOGICAL

Placebo

OTHER

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

NCT07379580

Mpox (Monkeypox)Smallpox+1 more

View study

RECRUITINGNA

Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

NCT06887556

Mpox

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Randomized Clinical Trial Investigating the Safety, Reactogenicity, and Immunogenicity After Immunization With an mRNA-based Mpox Vaccine Candidate in Africa

Mpox Comprehensive Assessment for Responsive Immunisation in Emergency Outbreaks

Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part2)

Epidemiological and Clinical Characteristics of Human Mpox Outbreak in Equateur Province in the Democratic Republic of Congo (Part3)

Study to Assess the Safety and Immunogenicity of TPOXX® When Administered Orally for 28 Days With JYNNEOS

Monkeypox, Biology, Outcome, Transmission and Epidemiology -Prospective Follow-up of High-risk Contacts