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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
Must not have
Live, attenuated vaccine within 14 days of study agent
Receipt of liver transplant prior to dose 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the study

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.
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.
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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not received a live vaccine in the last 14 days.
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I have received a liver transplant before my second dose.
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I have not received any immunoglobulin treatment in the last 3 months.
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I have had a stem cell transplant in the past.
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I am currently taking medication to suppress my immune system.
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I've been taking 20 mg or more of steroids daily for the last month.
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I haven't received T- or B-cell depleting treatments in the last 6 months.
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I have not received a vaccine within the last 14 days.
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I had a severe allergic reaction to the first dose of a medication.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 7 days of each dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 7 days of each dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percent of participants with pre-transplant treatment emergent adverse events (TEAE)
Percent of participants with solicited adverse reactions
Percent of participants with treatment emergent serious adverse events (TESAE)

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

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,322 Previous Clinical Trials
5,364,322 Total Patients Enrolled
Ajit P Limaye, MDStudy ChairUniversity of California, San Francisco: Transplantation
Cindy Fisher, M.D.Study ChairUniversity of Washington Medical Center: Transplantation
~277 spots leftby Jun 2027
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