search
Back to results

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

Primary Purpose

Cytomegalovirus Infection

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
mRNA-1647
Placebo
Sponsored by
ModernaTX, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cytomegalovirus Infection focused on measuring Human cytomegalovirus, Human Herpesvirus, mRNA-1647, Moderna, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Disease, Infection Viral, DNA Virus Infections, Messenger RNA, Hematopoietic cell transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Receipt of an allogeneic HCT. CMV-seropositive, defined as a documented positive test for anti-CMV IgG. High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCT from related or unrelated donor with myeloablative conditioning. Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first vaccination. Persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. Persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months following last vaccination. Persons who are not currently breast/chestfeeding. Willingness to comply with study procedures and provide written informed consent. Exclusion Criteria: History of a diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. A documented positive human immunodeficiency virus (HIV) test. Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent in-vivo T cell depleting agent within 12 months. HCT with ex-vivo T cell depletion. Low risk for CMV: HCT from related or unrelated donor with RIC and no other high-risk features. History of prior hematopoietic cell transplantation within 12 months. Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic trial that may interfere with study outcome measures as determined by the Investigator. Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.

Sites / Locations

  • Dana-Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

mRNA-1647

Placebo

Arm Description

Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.

Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.

Outcomes

Primary Outcome Measures

Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Number of Unsolicited Adverse Events (AEs)
Number of Participants with Severe AEs
Number of Participants with Serious Adverse Events (SAEs)
Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)

Secondary Outcome Measures

Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease
Number of Participants with an Occurrence of CMV Viremia
CMV Viremia is defined as ≥300 international units/milliliters (IU/mL).
Number of Participants with CMV End-Organ Disease
Duration of CMV Viremia
Duration of CMV Treatment
Number of Participants with Non-Relapse Mortality at 9 Months PostHCT.
Titer of CMV-Specific Neutralizing Antibody (nAb)
Geometric Mean Titer (GMT) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline GMTs or GMCs

Full Information

First Posted
January 4, 2023
Last Updated
April 15, 2023
Sponsor
ModernaTX, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05683457
Brief Title
A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.
Official Title
A Phase 2, Observer-Blind, Placebo-Controlled Proof-of-Concept Trial to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus Vaccine in Patients Who Have Undergone Allogeneic Hematopoietic Cell Transplantation (HCT)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2023 (Actual)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
August 1, 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
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of the study is to evaluate the efficacy and safety of mRNA-1647 compared to placebo to prevent first clinically significant cytomegalovirus infection (CS-CMVi) in the period following cessation of CMV prophylactic treatment (for example, letermovir) on Day 100 postHCT through Month 9 postHCT.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Infection
Keywords
Human cytomegalovirus, Human Herpesvirus, mRNA-1647, Moderna, CMV, Cytomegalovirus Vaccine, Cytomegalovirus Infections, Cytomegalovirus Congenital, Virus Disease, Infection Viral, DNA Virus Infections, Messenger RNA, Hematopoietic cell transplantation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mRNA-1647
Arm Type
Experimental
Arm Description
Participants will receive mRNA-1647 vaccine by intramuscular (IM) injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive mRNA-1647 vaccine matching placebo by IM injection on Day 42, Day 67, and Day 92, and a booster dose on Day 180.
Intervention Type
Biological
Intervention Name(s)
mRNA-1647
Intervention Description
Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline).
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% sodium chloride (normal saline) injection
Primary Outcome Measure Information:
Title
Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy
Time Frame
Day 100 to Month 9
Title
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time Frame
Up to Day 187 (7 days after last study injection)
Title
Number of Unsolicited Adverse Events (AEs)
Time Frame
Up to Day 205 (25 days after last study injection)
Title
Number of Participants with Severe AEs
Time Frame
Up to Day 365
Title
Number of Participants with Serious Adverse Events (SAEs)
Time Frame
Up to Day 365
Title
Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)
Time Frame
Up to Day 365
Secondary Outcome Measure Information:
Title
Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease
Time Frame
Day 100 to Month 9
Title
Number of Participants with an Occurrence of CMV Viremia
Description
CMV Viremia is defined as ≥300 international units/milliliters (IU/mL).
Time Frame
Day 100 to Month 9
Title
Number of Participants with CMV End-Organ Disease
Time Frame
Day 100 to Month 9
Title
Duration of CMV Viremia
Time Frame
Day 100 to Month 9
Title
Duration of CMV Treatment
Time Frame
Day 100 to Month 9
Title
Number of Participants with Non-Relapse Mortality at 9 Months PostHCT.
Time Frame
Month 9
Title
Titer of CMV-Specific Neutralizing Antibody (nAb)
Time Frame
Days 42, 67, 92, 117, 180, 205 and 270
Title
Geometric Mean Titer (GMT) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time Frame
Days 42, 67, 92, 117, 180, 205 and 270
Title
Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)
Time Frame
Days 42, 67, 92, 117, 180, 205 and 270
Title
Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline GMTs or GMCs
Time Frame
Days 42, 67, 92, 117, 180, 205 and 270

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Receipt of an allogeneic HCT. CMV-seropositive, defined as a documented positive test for anti-CMV IgG. High-risk for CMV: HCT from related, unrelated, or haploidentical donor with post-transplant cyclophosphamide for graft-versus-host-disease (GVHD) prophylaxis; or HCT from related or unrelated donor with at least one mismatch at any of the following human leukocyte antigen (HLA) gene loci (HLA-A, B, C, and DRB1); or HCT from related or unrelated donor with myeloablative conditioning. Persons of nonchildbearing potential or of childbearing potential with negative urine or serum pregnancy test on the day of first vaccination. Persons of childbearing potential who have practiced adequate contraception or have abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose. Persons of childbearing potential who have agreed to continue adequate contraception or abstain from all activities that could result in pregnancy through 3 months following last vaccination. Persons who are not currently breast/chestfeeding. Willingness to comply with study procedures and provide written informed consent. Exclusion Criteria: History of a diagnosis or condition that, in the judgment of the Investigator, may affect participant safety, assessment of safety endpoints, assessment of immune response, or adherence to study procedures. A documented positive human immunodeficiency virus (HIV) test. Treatment with alemtuzumab (Campath®), antithymocyte globulin (ATG), or any equivalent in-vivo T cell depleting agent within 12 months. HCT with ex-vivo T cell depletion. Low risk for CMV: HCT from related or unrelated donor with RIC and no other high-risk features. History of prior hematopoietic cell transplantation within 12 months. Receipt of prior investigational CMV vaccines or participation in another CMV therapeutic trial that may interfere with study outcome measures as determined by the Investigator. Suspected or known allergic reaction to any component of any mRNA vaccine or its excipients.
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
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants.

We'll reach out to this number within 24 hrs