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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

Primary Purpose

Smallpox, Mpox

Status
Recruiting
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
mRNA-1769
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smallpox focused on measuring mRNA-1769 vaccine, mRNA-1769, Moderna

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bradford Teaching Hospitals NHS Foundation TrustRecruiting
  • University Hospitals Bristol and Weston NHS Foundation TrustRecruiting
  • Lakeside Healthcare ResearchRecruiting
  • University Hospitals of LeicesterRecruiting
  • Liverpool University Hospitals NHS Foundation TrustRecruiting
  • Barts Health NHS TrustRecruiting
  • University College London HospitalsRecruiting
  • Royal Free London NHS Foundation Trust
  • Chelsea and Westminster Hospital NHS Foundation TrustRecruiting
  • Medicines Evaluation Unit
  • Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
  • North Wales Clinical Research Facility Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

mRNA-1769 Dose A

mRNA-1769 Dose B

mRNA-1769 Dose C

Placebo

Arm Description

Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.

Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.

Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.

Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.

Outcomes

Primary Outcome Measures

Number of Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) Through 7 Days After Each Investigational Medicinal Product (IMP)
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
Number of Participants with Medically-Attended AEs (MAAEs)
Number of Participants with Adverse Events of Special Interest (AESIs)
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation

Secondary Outcome Measures

Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV
Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus
Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay
Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus

Full Information

First Posted
August 9, 2023
Last Updated
October 24, 2023
Sponsor
ModernaTX, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05995275
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2023 (Actual)
Primary Completion Date
February 14, 2025 (Anticipated)
Study Completion Date
February 14, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ModernaTX, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smallpox, Mpox
Keywords
mRNA-1769 vaccine, mRNA-1769, Moderna

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1769 Dose A
Arm Type
Experimental
Arm Description
Participants will receive intramuscular (IM) injection of mRNA-1769 at Dose A on Day 1 and Day 29.
Arm Title
mRNA-1769 Dose B
Arm Type
Experimental
Arm Description
Participants will receive IM injection of mRNA-1769 at Dose B on Day 1 and Day 29.
Arm Title
mRNA-1769 Dose C
Arm Type
Experimental
Arm Description
Participants will receive IM injection of mRNA-1769 at Dose C on Day 1 and Day 29.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive IM injection of placebo matched to mRNA-1769 on Day 1 and Day 29.
Intervention Type
Biological
Intervention Name(s)
mRNA-1769
Intervention Description
Sterile liquid for injection
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride injection (normal saline)
Primary Outcome Measure Information:
Title
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
Title
Number of Unsolicited Adverse Events (AEs) Through 7 Days After Each IMP
Time Frame
Up to Day 57
Title
Number of Participants with Medically-Attended AEs (MAAEs)
Time Frame
Day 1 up to Day 395
Title
Number of Participants with Adverse Events of Special Interest (AESIs)
Time Frame
Day 1 up to Day 395
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Day 1 up to Day 395
Title
Number of Participants with AEs Leading to Study and/or Treatment Discontinuation
Time Frame
Day 1 up to Day 395
Secondary Outcome Measure Information:
Title
Geometric Mean Titer (GMT) of Neutralising Antibody (nAb) against Mpox Virus (MPXV) by Plaque reduction neutralisation test (PRNT)
Time Frame
Days 1 and 43
Title
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against MPXV
Time Frame
Days 1 and 43
Title
Geometric Mean Concentration of Binding Antibodies (bAbs) Against MPXV Antigens by Meso Scale Discovery (MSD) Assay
Time Frame
Days 1, 29, 43, and 57
Title
Percentage of Participants With Seroconversion Based on Binding Antibodies (bAb) Responses against MPXV
Time Frame
Days 1, 29, 43, and 57
Title
Geometric Mean Titer of Neutralising Antibody Against Vaccinia Virus (VACV) by Plaque Reduction Neutralisation Test (PRNT)
Time Frame
Days 1 and 43
Title
Percentage of Participants With Seroconversion Based on Neutralising Antibody Responses Against Vaccinia Virus
Time Frame
Days 1 and 43
Title
Geometric Mean Concentration of Binding Antibodies Against Vaccinia Virus Antigens by Meso Scale Discovery Assay
Time Frame
Days 1, 29, 43, and 57
Title
Percentage of Participants With Seroconversion Based on Binding Antibodies Responses Against Vaccinia Virus
Time Frame
Days 1, 29, 43, and 57

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Moderna Clinical Trials Support Center
Phone
1-877-777-7187
Email
clinicaltrials@modernatx.com
Facility Information:
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol and Weston NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8DX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Lakeside Healthcare Research
City
Corby
ZIP/Postal Code
NN17 2UR
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University Hospitals of Leicester
City
Leicester
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Liverpool University Hospitals NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 4DG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospitals
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SW10 9NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Medicines Evaluation Unit
City
Manchester
ZIP/Postal Code
M23 9QZ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM)
City
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
North Wales Clinical Research Facility Centre
City
Wrexham
ZIP/Postal Code
LL13 7YP
Country
United Kingdom
Individual Site Status
Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

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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