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

Smallpox Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05995275
• Other study ID #: mRNA-1769-P101
• Status: Active, not recruiting
• Phase: Phase 1/Phase 2
• Start date: August 15, 2023
• Est. completion date: June 13, 2025

Study information

• Verified date: June 2024
• Source: ModernaTX, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 351
• Est. completion date: June 13, 2025
• Est. primary completion date: June 13, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smallpox

Intervention

Biological:
• mRNA-1769
Sterile liquid for injection

Other:
• Placebo
0.9% sodium chloride injection (normal saline)

Locations

Country	Name	City	State
United Kingdom	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	Chelsea and Westminster Hospital NHS Foundation Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London
United Kingdom	University College London Hospitals	London
United Kingdom	Medicines Evaluation Unit	Manchester
United Kingdom	Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)	Oxford
United Kingdom	North Wales Clinical Research Facility Centre	Wrexham

Sponsors (1)

Lead Sponsor	Collaborator
ModernaTX, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)		Up to Day 35
Primary	Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP		Up to Day 57
Primary	Number of Participants with Medically-Attended AEs (MAAEs)		Day 1 up to Day 395
Primary	Number of Participants with Adverse Events of Special Interest (AESIs)		Day 1 up to Day 395
Primary	Number of Participants with Serious Adverse Events (SAEs)		Day 1 up to Day 395
Primary	Number of Participants with AEs Leading to Study and/or Treatment Discontinuation		Day 1 up to Day 395
Secondary	Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)		Days 1 and 43
Secondary	Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV		Days 1 and 43
Secondary	Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay		Days 1, 29, 43, and 57
Secondary	Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV		Days 1, 29, 43, and 57
Secondary	Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)		Days 1 and 43
Secondary	Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus		Days 1 and 43
Secondary	Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay		Days 1, 29, 43, and 57
Secondary	Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus		Days 1, 29, 43, and 57