Cytomegalovirus Infection Clinical Trial
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)
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.
Status | Recruiting |
Enrollment | 224 |
Est. completion date | August 1, 2025 |
Est. primary completion date | August 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
ModernaTX, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to the First Occurrence of an CS-CMVi Event as Measured by initiation of anti-CMV Antiviral Therapy | Day 100 to Month 9 | ||
Primary | Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | Up to Day 187 (7 days after last study injection) | ||
Primary | Number of Unsolicited Adverse Events (AEs) | Up to Day 205 (25 days after last study injection) | ||
Primary | Number of Participants with Severe AEs | Up to Day 365 | ||
Primary | Number of Participants with Serious Adverse Events (SAEs) | Up to Day 365 | ||
Primary | Number of Participants with Grade =3 Acute Graft-Versus-Host Disease (GVHD) | Up to Day 365 | ||
Secondary | Number of Participants with First Occurrence of All CS-CMVi Events as Measured by Initiation of Anti-CMV Antiviral and/or End-Organ Disease | Day 100 to Month 9 | ||
Secondary | Number of Participants with an Occurrence of CMV Viremia | CMV Viremia is defined as =300 international units/milliliters (IU/mL). | Day 100 to Month 9 | |
Secondary | Number of Participants with CMV End-Organ Disease | Day 100 to Month 9 | ||
Secondary | Duration of CMV Viremia | Day 100 to Month 9 | ||
Secondary | Duration of CMV Treatment | Day 100 to Month 9 | ||
Secondary | Number of Participants with Non-Relapse Mortality at 9 Months PostHCT. | Month 9 | ||
Secondary | Titer of CMV-Specific Neutralizing Antibody (nAb) | Days 42, 67, 92, 117, 180, 205 and 270 | ||
Secondary | Geometric Mean Titer (GMT) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Days 42, 67, 92, 117, 180, 205 and 270 | ||
Secondary | Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | Days 42, 67, 92, 117, 180, 205 and 270 | ||
Secondary | Geometric Mean Fold Rise (GMFR) of Postbaseline/Baseline GMTs or GMCs | Days 42, 67, 92, 117, 180, 205 and 270 |
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