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Cancer Vaccine

CMV Vaccine for Liver Transplant Recipients (COLT Trial)

Phase 2

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

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

Must have

Anticipated to receive a liver transplant within 1-12 months

Subject must be able to understand and provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up by 6 months post-transplant (tx)

Awards & highlights

COLT Trial Summary

This trial will study the effects of two doses of a CMV vaccine on preventing CMV disease in liver transplant recipients, using a protocol-mandated preemptive therapy strategy.

Who is the study for?

This trial is for CMV-negative people listed for their first liver transplant, who understand the study and consent to it. They must not have HIV or a history of positive CMV serology, be likely to get a transplant within 1-12 months, and if they can have children, agree to use birth control. People with recent vaccinations, certain immune conditions or treatments, breastfeeding women, those in other trials that affect this one's outcomes or who've had stem cell transplants are excluded.Check my eligibility

What is being tested?

The trial tests the efficacy of two doses of a vaccine called CMV-MVA Triplex against placebo in preventing Cytomegalovirus infection after liver transplantation. Participants will either receive the vaccine or placebo before their transplant and will be monitored for how long they need antiviral therapy post-transplant.See study design

What are the potential side effects?

While specific side effects aren't listed here, vaccines like CMV-MVA Triplex may cause reactions at the injection site (like pain or swelling), feverish symptoms (such as mild fever), fatigue, headaches and muscle pains which typically resolve without treatment.

COLT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am expected to get a liver transplant within the next year.

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I understand the study and can give my consent.

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I have tested negative for HIV and show no signs of having it.

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I am on the list for my first liver transplant.

COLT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ by 6 months post-transplant (tx)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~by 6 months post-transplant (tx)

This trial's timeline: 3 weeks for screening, Varies for treatment, and by 6 months post-transplant (tx) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Percent of participants with pre-transplant treatment emergent adverse events (TEAE)

Percent of participants with pre-transplant treatment emergent serious adverse events (TESAE)

Percent of participants with solicited adverse reactions

+2 more

Secondary outcome measures

Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop CMV DNAemia >= 1000 IU/mL

Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint committee adjudicated CMV disease

Percent of seropositive donor (D+) and seronegative (R-) liver transplant recipients (D+R- LTxRs) who develop Endpoint-Committee adjudicated Cytomegalovirus (CMV) disease

+4 more

COLT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Vaccine ArmExperimental Treatment1 Intervention

Participants in this arm will receive two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine

Group II: Placebo ArmPlacebo Group1 Intervention

Participants will receive two doses of matching placebo of the Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,484,821 Total Patients Enrolled

Ajit P Limaye, MDStudy ChairUniversity of Washington Medical Center: Transplantation

Cindy Fisher, M.D.Study ChairUniversity of Washington Medical Center: Transplantation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Vaccine Arm been officially recognized by the FDA?

"Vaccine Arm was assessed with a safety score of 2 due to the clinical evidence backing its security, although no studies have measured its effectiveness."

Answered by AI

Is this experiment currently in need of participants?

"According to clinicaltrials.gov, this investigation is not presently looking for participants. The research was first launched on December 1st 2023 and recently amended on October 4th 2023. Yet fortunately, there are 104 other trials now recruiting patients as of today."

Answered by AI

How many medical facilities offer participation in this trial?

"The research team has established clinical trial sites at the University of California in San Francisco, Florida's Jackson Memorial Hospital and Emory University Hospital in Atlanta. Additionally, 17 other medical facilities are participating in this study across the US."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates

2024. "Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06075745.

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