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CMV-MVA Triplex Vaccine for Blood Cancers
Study Summary
This trial looks at a vaccine for stem cell donors to see if it can prevent CMV viremia (a virus) in blood cancer patients undergoing a stem cell transplant from the donor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2012 Phase 3 trial • 6104 Patients • NCT01346592Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- I will be taking specific medications from my transplant until day 70 after.I have a sickle cell disease needing a transplant.I have received Alemtuzumab or a similar medication.I am taking antiviral medications effective against CMV.I have been diagnosed with an autoimmune disease.I am receiving preventive treatment for CMV.I am not taking any medications that could affect the study's drug evaluation.My donor for the transplant is a perfect 8/8 HLA match.My treatment plan follows my hospital's guidelines for preparing my body for a transplant.I am scheduled for a stem cell transplant to treat my blood cancer.I am between 18 and 75 years old.I am willing to get the Triplex vaccine at least 14 days before stem cell collection.I have not received any live vaccines recently.My donor has a heart condition.My donor is positive for HIV, HBV, HCV, or HTLV-I/II.I have not received experimental anti-CMV chemotherapy in the last 6 months.I have received vaccines that are either subunit or killed.I cannot undergo standard procedures to prepare for a stem cell transplant.I can be vaccinated before knowing my HIV, HBV, HCV, and HTLV status.I understand this study is experimental and I can give my consent.
- Group 1: Receipient (multi-peptide CMV-modified vaccinia Ankara vaccine)
- Group 2: Donor (multi-peptide CMV-modified vaccinia Ankara vaccine)
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are elderly individuals being sought out for this test program?
"This trial includes anyone aged 18-80, which is a larger age range than most clinical trials. Out of the nearly 6000 other active trials, 950 are for children and 4963 are for adults over 65 years old."
How many participants are enrolled in this trial currently?
"Unfortunately, this particular trial is no longer recruiting patients. If you're looking for other opportunities, there are 5529 trials seeking participants with hematopoietic cell transplant recipient and 17 studies for Multi-peptide CMV-Modified Vaccinia Ankara Vaccine that are still enrolling patients."
Is the FDA's approval necessary to use Multi-peptide CMV-Modified Vaccinia Ankara Vaccine?
"The safety of Multi-peptide CMV-Modified Vaccinia Ankara Vaccine is rated as a 2. Although there is some data collected supporting its safety, Phase 2 trials have not yet demonstrated efficacy."
Can cancer patients currently enroll in this trial?
"This study has completed its recruitment of patients. The trial was first posted on August 20th, 2018 and the last update to the posting was September 28th, 2022. However, there are other ongoing trials that may be of interest. For example, there are 5529 trials involving hematopoietic cell transplant recipients and 17 studies for Multi-peptide CMV-Modified Vaccinia Ankara Vaccine currently recruiting participants."
Are there other scientific investigations that have involved Multi-peptide CMV-Modified Vaccinia Ankara Vaccine?
"There are a total of 17 ongoing clinical trials researching Multi-peptide CMV-Modified Vaccinia Ankara Vaccine. As this is such a new treatment, none of these studies have advanced to Phase 3 yet. The majority of the research for this vaccine is being conducted in Boston, Massachusetts but there are 76 sites running trials for this medication across the United States."
To what extent does this research opportunity restrict potential participants?
"Up to 34 people who have undergone hematopoietic cell transplantation will be allowed into the trial, so long as they are between 18 and 80 years old. Most importantly, applicants should meet the following conditions: DONOR: Must understand that this is an investigational study and provide informed consent, DONOR: Willing to receive Triplex vaccination at least 14 days before PBSC collection, DONOR VACCINATION: Donors are eligible to be vaccinated prior to the determination of their human immunodeficiency virus (HIV), hepatitis b virus (HBV), hepatitis c virus (HCV) and human T"
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