mRNA-1647 / Moderna - LARVOL DELTA

mRNA-1647-P205: 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=84 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Trial completion date: Aug 2026 ➔ Mar 2027 | Trial primary completion date: Aug 2026 ➔ Mar 2027

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

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 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Jan 2027 ➔ May 2026 | Trial primary completion date: Jan 2027 ➔ May 2026

Trial completion • Trial completion date • Trial primary completion date • Cytomegalovirus Infection

Biodistribution of mRNA vaccines in rats: Enrichment in injection site and lymph tissues and rapid clearance without tissue persistence. (PubMed, Mol Ther Nucleic Acids) - "Here, we describe tissue distribution and kinetics of mRNA-LNP vaccines after intramuscular dosing using three products formulated with same LNP matrix: mRNA-1273 (Spikevax), mRNA-1647 (a candidate cytomegalovirus [CMV] vaccine), and a reporter mRNA (nascent peptide-luciferase) drug product. Furthermore, in a SARS-CoV-2 infection-free model, no sustained spike protein was observed. Overall, the data establish a framework that can be used to scientifically justify leveraging data across a shared platform."

Journal • Preclinical • Cytomegalovirus Infection • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of the Cytomegalovirus Vaccine mRNA-1647 in Healthy Adults: Results from a Phase 2, Randomized, Controlled, Dose-Finding Trial with Long-Term Extension Follow-Up Through Month 48. (PubMed, Vaccines (Basel)) - P2 | "Neutralizing antibody and antigen-specific binding IgG responses were induced in CMV-seronegative participants and boosted in CMV-seropositive participants, with durability of responses through Month 48 and up to Month 54. The investigational vaccine mRNA-1647 was generally well tolerated and induced durable humoral immune responses across baseline CMV serostatus, with persistence supported through Month 48 and by available Month 54 data."

Journal • P2 data • Cytomegalovirus Infection • Infectious Disease

mRNA-1647-P205: 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=84 | Active, not recruiting | Sponsor: ModernaTX, Inc. | Recruiting ➔ Active, not recruiting | N=224 ➔ 84

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

Development & clinical validation of microneutralization assays for the robust quantification of neutralizing antibodies to human cytomegalovirus. (IMMUNOLOGY 2026) - "These validated hCMV MN assays demonstrated acceptable accuracy, precision, linearity, stability, and specificity across the dynamic range, enabling reliable, strain- and cell type–specific quantification of nAb responses for clinical evaluation of mRNA-1647."

Clinical • Cytomegalovirus Infection • Infectious Disease

mRNA-CRID-001: A Study of Modified mRNA Vaccines in Healthy Adults (clinicaltrials.gov) - P1 | N=308 | Completed | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Completed

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

A Long-Term Extension Study to Evaluate the Immunogenicity and Safety of Cytomegalovirus (CMV) mRNA-1647 Vaccine (clinicaltrials.gov) - P2 | N=135 | Completed | Sponsor: ModernaTX, Inc. | Enrolling by invitation ➔ Completed | N=291 ➔ 135 | Trial completion date: Dec 2026 ➔ Jan 2026 | Trial primary completion date: Dec 2026 ➔ Jan 2026

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

Cytomegalovirus in Pregnancy: Effects on the Developing Embryo and Fetus, Diagnosis and Treatment: Where to Go Now? A Narrative Review. (PubMed, Int J Mol Sci) - "Assessment of viral load enables prediction of fetal infection; its reduction by maternal treatment with valacyclovir may lower both the rate and severity of transmission...Pharmacological treatment with ganciclovir or valganciclovir, if initiated early after birth, can slow the progression of hearing loss and may ameliorate other neurological and neurodevelopmental deficits...The mRNA-1647's vaccine, currently in phase 3 clinical trial, appears promising...Neurodevelopmental follow up for several years, including hearing and visual assessment, is advised in all infants positive for CMV. Infants with clinical manifestations should be offered treatment as early as possible following diagnosis of cCMV."

Journal • Review • Cytomegalovirus Infection • Infectious Disease • Otorhinolaryngology

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 | Terminated | Sponsor: ModernaTX, Inc. | Active, not recruiting ➔ Terminated | Trial primary completion date: Apr 2026 ➔ Nov 2025 | Trial completion date: Apr 2028 ➔ Nov 2025; The Sponsor decided to terminate the study after it did not meet the primary efficacy endpoint at final analysis. The safety profile was consistent with prior studies, and no safety concerns were raised by the Data and Safety Monitoring Board.

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

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