What side effects are associated with this type of intervention?

Common treatments for Cytomegalovirus (CMV) include antiviral medications such as ganciclovir, valganciclovir, foscarnet, and cidofovir, which can cause side effects like bone marrow suppression (neutropenia, anemia, thrombocytopenia), renal toxicity, and gastrointestinal symptoms. Vaccines designed to elicit an immune response against CMV, such as the mRNA-1647 vaccine, may cause side effects including injection site reactions, fever, fatigue, and muscle aches.

What prior FDA approvals exist?

The FDA has approved several antiviral drugs for the treatment of Cytomegalovirus (CMV) infections, particularly in immunocompromised patients. These include ganciclovir, valganciclovir, foscarnet, and cidofovir. These drugs work by inhibiting viral DNA replication. While there are no FDA-approved vaccines specifically for CMV, the mRNA-1647 vaccine currently under study aims to prevent CMV infection by eliciting an immune response, representing a novel approach compared to existing antiviral treatments.

What other types of research exist?

Promising alternatives to mRNA-1647 for CMV patients include: 1) Letermovir, an antiviral drug used for CMV prophylaxis in transplant patients, which has shown efficacy in preventing CMV infection. 2) Adoptive T-cell therapy, which involves the infusion of CMV-specific T cells to boost the immune response against CMV. 3) Other CMV vaccine candidates in development, such as those based on viral vectors or protein subunits, which are being evaluated in clinical trials for their safety and efficacy.

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Virus Therapy

mRNA-1647 Vaccine for Cytomegalovirus Infection

Phase 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 9

Awards & highlights

Summary

This trial will study if a new drug (mRNA-1647) can help prevent a virus infection after a stem cell transplant.

Who is the study for?

This trial is for adults who've had a bone marrow transplant, are at high risk for CMV infection, and have working major organs. They must not be pregnant or breastfeeding, agree to use contraception, and can't have HIV or recent treatments that weaken the immune system.Check my eligibility

What is being tested?

The study tests mRNA-1647 vaccine's effectiveness in preventing significant CMV infections after stopping standard anti-CMV drugs post-transplant. Participants will either receive the vaccine or a placebo to compare results.See study design

What are the potential side effects?

Potential side effects of mRNA-1647 may include typical reactions seen with other vaccines such as pain at injection site, fatigue, headache, muscle pain, chills, fever and nausea.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 9

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 9

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 9 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with Grade ≥3 Acute Graft-Versus-Host Disease (GVHD)

Number of Participants with Serious Adverse Events (SAEs)

Number of Participants with Severe AEs

+3 more

Secondary outcome measures

Duration of CMV Treatment

Duration of CMV Viremia

Geometric Mean Concentration (GMC) of Anti-gB-Specific Immunoglobulin G (IgG) and Anti-Pentamer-Specific IgG as Measured by Enzyme-Linked Immunosorbent Assay (ELISA)

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: mRNA-1647Experimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

mRNA-1647

2021

Completed Phase 2

~510

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cytomegalovirus (CMV) include antiviral medications and vaccines. Antiviral drugs like ganciclovir and valganciclovir inhibit viral DNA replication, preventing the virus from multiplying. Vaccines, such as the mRNA-1647, work by introducing viral antigens to stimulate the immune system to recognize and combat the virus. These treatments are crucial for managing and preventing CMV infections, especially in immunocompromised patients and transplant recipients, where CMV can lead to severe complications.

[Monitoring of cytomegalovirus-specific CD4+ and CD8+ T cell responses by cytokine flow cytometry in renal transplant recipients].Strategies for the prevention of cytomegalovirus infection and disease in pediatric liver transplantation recipients.

Find a Location

Who is running the clinical trial?

ModernaTX, Inc.Lead Sponsor

108 Previous Clinical Trials

61,379,740 Total Patients Enrolled

Media Library

mRNA-1647 Cytomegalovirus (CMV) Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05683457 — Phase 2

Cytomegalovirus Research Study Groups: Placebo, mRNA-1647

Cytomegalovirus Clinical Trial 2023: mRNA-1647 Cytomegalovirus (CMV) Vaccine Highlights & Side Effects. Trial Name: NCT05683457 — Phase 2

mRNA-1647 Cytomegalovirus (CMV) Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683457 — Phase 2

~100 spots leftby Aug 2025

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