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RECRUITING
NCT05683457
PHASE2

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

Sponsor: ModernaTX, Inc.

View on ClinicalTrials.gov

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 post-HCT through Month 9 post-HCT.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

224

Start Date

2023-04-05

Completion Date

2026-08-01

Last Updated

2026-03-16

Healthy Volunteers

No

Interventions

BIOLOGICAL

mRNA-1647

Lyophilized product that is reconstituted with 0.9% sodium chloride (normal saline).

BIOLOGICAL

Placebo

0.9% sodium chloride (normal saline) injection

Locations (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States