mRNA-1647 / Moderna - LARVOL DELTA

An mRNA-based cytomegalovirus vaccine induces robust T-cell immune responses in cytomegalovirus-seropositive adults who have undergone allogeneic hematopoietic cell transplantation (ASH 2025) - P1, P2 | "Starting at 1 month post-dose 2, mRNA-1647 elicited antigen-specific, highly polyfunctionalCD4+ and CD8+ T-cell responses in CMV-seropositive high-risk HCT recipients that were equivalent to orexceeded T-cell responses induced in healthy adults. These findings support continued evaluation ofmRNA-1647 safety, immunogenicity, and efficacy in high-risk adult populations."

Clinical • Cytomegalovirus Infection • Infectious Disease • Transplantation • CD4 • CD8

Safety and Immunogenicity of mRNA-1647 in Participants Aged 9-15 Years: Interim Results from the Phase 1/2a Study (AAP-NCE 2025) - P1/2 | "This dose-finding trial marks the first pediatric trial of the candidate CMV vaccine mRNA-1647. mRNA-1647 was generally well-tolerated with no safety concerns identified, and antigen-specific immunogenicity was demonstrated at all dose levels regardless of CMV serostatus. These data supported the selection of the 100-µg dose for advancement into late-stage development."

Clinical • P1/2 data • CNS Disorders • Cytomegalovirus Infection • Depression • Infectious Disease • Pediatrics • Psychiatry

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age (clinicaltrials.gov) - P1/2 | N=873 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection

Health and economic evaluation of cytomegalovirus vaccination strategy among young women in China: a modelling study. (PubMed, BMJ Public Health) - "Recent clinical trials demonstrated that the messenger RNA (mRNA) vaccine candidate, mRNA-1647, exhibited potential efficacy in both preinfection and postinfection contexts...Prioritising pre-marriage vaccination could control cCMV infection in China. Our findings would inform public health policies and guide future research on optimising CMV vaccination strategies."

HEOR • Journal • Cytomegalovirus Infection • Infectious Disease

Shared clinical and immunologic features of mRNA vaccines: preliminary results from a comparative clinical study. (PubMed, Front Immunol) - P1 | "This ongoing, open-label, phase 1 trial randomized healthy adults (18-75 years) to receive a single dose of mRNA-1273.222 (bivalent COVID-19), mRNA-1345 (RSV), mRNA-1010 (influenza), and FLUAD (active influenza comparator) or 2 or 3 doses of mRNA-1647 (CMV). This suggests that the observed reactogenicity of mRNA vaccines may be related to shared features of the mRNA platform (LNP platform). ClinicalTrials.gov, identifier NCT05397223."

Clinical • Journal • Infectious Disease • Inflammation • Influenza • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • CCL4 • CCL8 • CD4 • CD8 • CXCL9 • IFNG • IL1R1 • IL2RA • IL6

Long-term safety and immunogenicity of cytomegalovirus mRNA-1647 vaccine in healthy adults: 36-month results from a phase 2 extension trial (ESCMID Global 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Cytomegalovirus Infection

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants. (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Infectious Disease • Transplantation • HLA-B • HLA-C • HLA-DRB1

The mRNA-1647 vaccine: A promising step toward the prevention of cytomegalovirus infection (CMV). (PubMed, Hum Vaccin Immunother) - "The ongoing Phase 3 CMVictory trial evaluates the safety and immunogenicity of mRNA-1647 in women of childbearing age, with preliminary data showing promise in preventing congenital CMV transmission. This vaccine could significantly reduce CMV-related morbidity and mortality, particularly in newborns and immunocompromised individuals, addressing a critical unmet medical need."

Journal • Review • Cytomegalovirus Infection • Infectious Disease

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age (clinicaltrials.gov) - P1/2 | N=770 | Recruiting | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Recruiting

Enrollment open • Cytomegalovirus Infection

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age (clinicaltrials.gov) - P3 | N=7454 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Apr 2026 ➔ Apr 2028

Trial completion date • Cytomegalovirus Infection • Infectious Disease

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age (clinicaltrialsregister.eu) - P1/2 | N=770 | Sponsor: ModernaTX, Inc.

New P1/2 trial • Cytomegalovirus Infection • Infectious Disease

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age (clinicaltrials.gov) - P1/2 | N=770 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial primary completion date • Cytomegalovirus Infection

A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Mar 2024 ➔ Feb 2026 | Trial primary completion date: Mar 2024 ➔ Feb 2026

Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Infectious Disease • Influenza • Novel Coronavirus Disease • Respiratory Diseases

Characterization of humoral and cellular immunologic responses to an mRNA-based human cytomegalovirus vaccine from a phase 1 trial of healthy adults. (PubMed, J Virol) - P1 | "The current analysis examined samples from a phase 1 trial of mRNA-1647 in healthy adults to better understand how the immune system reacts to vaccination. Three doses of mRNA-1647 produced a long-lasting immune response, thus supporting further investigation of the vaccine in the prevention of CMV infection.CLINICAL TRIALSRegistered at ClinicalTrials.gov (NCT03382405)."

Journal • P1 data • Cytomegalovirus Infection • Infectious Disease • CD4 • CD8

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants. (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: ModernaTX, Inc. | Trial primary completion date: Feb 2025 ➔ Aug 2025

Trial primary completion date • Cytomegalovirus Infection • Infectious Disease • Transplantation • HLA-B • HLA-C • HLA-DRB1

A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: ModernaTX, Inc. | N=342 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Cytomegalovirus Infection • Hepatology • Infectious Disease • Transplantation

Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1, Randomized, Clinical Trial. (PubMed, J Infect Dis) - P1 | "This phase 1, first-in-human trial demonstrated mRNA-1647 has an acceptable safety profile in adults and elicits humoral and cellular immune responses."

Journal • P1 data • Cytomegalovirus Infection

A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients (clinicaltrials.gov) - P2 | N=342 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cytomegalovirus Infection • Hepatology • Infectious Disease • Transplantation

A Study of mRNA-1647 Cytomegalovirus Vaccine in Healthy Participants 9 to 15 Years of Age and Participants 16 to 25 Years of Age (clinicaltrials.gov) - P1/2 | N=770 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection

A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine (clinicaltrials.gov) - P2 | N=291 | Enrolling by invitation | Sponsor: ModernaTX, Inc. | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Cytomegalovirus Infection • Infectious Disease

Human Cytomegalovirus mRNA-1647 Vaccine Candidate Elicits Potent and Broad Neutralization and Higher Antibody-Dependent Cellular Cytotoxicity Responses Than the gB/MF59 Vaccine. (PubMed, J Infect Dis) - P1, P2 | "Overall, mRNA-1647 vaccination induced polyfunctional and durable HCMV-specific antibody responses, with lower gB-specific IgG responses but higher neutralization and ADCC responses compared to the gB/MF59 vaccine."

Journal • Cytomegalovirus Infection

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Healthy Participants 16 to 40 Years of Age (clinicaltrials.gov) - P3 | N=6900 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cytomegalovirus Infection • Infectious Disease

A Study of mRNA-1647 Cytomegalovirus Vaccine in Liver Transplant Candidates and Recipients (clinicaltrials.gov) - P2 | N=342 | Not yet recruiting | Sponsor: ModernaTX, Inc.

New P2 trial • Cytomegalovirus Infection • Hepatology • Infectious Disease • Transplantation

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus (CMV) Vaccine mRNA-1647 (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cytomegalovirus Infection • Infectious Disease

A Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1647 Cytomegalovirus (CMV) Vaccine in Allogenic Hematopoietic Cell Transplantation (HCT) Participants. (clinicaltrials.gov) - P2 | N=224 | Recruiting | Sponsor: ModernaTX, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Cytomegalovirus Infection • Infectious Disease • Transplantation • HLA-B • HLA-C • HLA-DRB1