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Cancer Vaccine

CMV-MVA Triplex Vaccine for Blood Cancers

Phase 2

Recruiting

Led By Vaibhav Agrawal

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

DONORS: Age: 18 and above

RECIPIENTS: Age: 18 and above

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from transplantation to the date of two consecutive cmv quantitative polymerase chain reaction (qpcr) > 500 gc/ml/465 iu/ml or single event of cmv qpcr >1500 cmv gc/ml/1,395 iu/ml, assessed up to 1 year post hct

Awards & highlights

Study Summary

This trial tests a vaccine to protect stem cell transplant patients from getting CMV infection.

Who is the study for?

This trial is for adult patients with certain blood cancers undergoing stem cell transplants and their HLA-matched related donors. Patients must have a good performance status, proper organ function, and agree to birth control post-transplant. Excluded are those with prior transplants, severe health conditions, or on conflicting treatments.Check my eligibility

What is being tested?

The study tests if the CMV-MVA Triplex vaccine given to stem cell donors can prevent CMV infection in transplant recipients. It's a phase II trial where the donor's immune response to CMV is hoped to be transferred to the patient through transplantation.See study design

What are the potential side effects?

Potential side effects of the vaccine may include typical reactions like soreness at injection site, fever, fatigue or allergic responses. Since it involves live attenuated viruses, there could also be a risk of transmitting vaccine-derived infections.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am 18 years old or older.

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I can take care of myself and perform daily activities.

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My donor for the transplant matches me perfectly in all 8 important genetic markers.

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If I have HIV, HCV, or HBV, my viral load is undetectable.

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I am planning a stem cell transplant for my blood cancer, but not for multiple myeloma.

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My kidneys work well, as shown by a test.

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My lung function tests are within the required range or my oxygen levels are above 92% without assistance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from transplantation to the date of two consecutive cmv quantitative polymerase chain reaction (qpcr) > 500 gc/ml/465 iu/ml or single event of cmv qpcr >1500 cmv gc/ml/1,395 iu/ml, assessed up to 1 year post hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from transplantation to the date of two consecutive cmv quantitative polymerase chain reaction (qpcr) > 500 gc/ml/465 iu/ml or single event of cmv qpcr >1500 cmv gc/ml/1,395 iu/ml, assessed up to 1 year post hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and from transplantation to the date of two consecutive cmv quantitative polymerase chain reaction (qpcr) > 500 gc/ml/465 iu/ml or single event of cmv qpcr >1500 cmv gc/ml/1,395 iu/ml, assessed up to 1 year post hct for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Incidence of grade 3 and higher AEs (safety in HCT-donors)

Incidence of severe acute graft versus host disease (aGHVD) (safety in HCT-recipients)

Incidence of severe adverse events (AEs) (safety in HCT-recipients)

+2 more

Secondary outcome measures

All-cause mortality (transplant-related events)

Cumulative number of CMV specific antiviral treatment days (CMV-related events)

Duration of viremia (CMV-related events)

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (Triplex vaccination)Experimental Treatment7 Interventions

DONORS: Donors receive Triplex vaccine IM on day 0 and then undergo stem cell mobilization with G-CSF on days 5 to 9 and apheresis for peripheral blood stem cell collection on days 10 to 14 per standard of care. Donors may optionally undergo blood sample collection on study. RECIPIENTS: Recipients undergo pre-transplant conditioning on days -60 to 0 and undergo HCT with the donor peripheral blood stem cells within 9 weeks of donor vaccination on day 0. Recipients undergo blood sample collection on study.

Group II: Arm II (Placebo)Placebo Group7 Interventions

DONORS: Donors receive placebo IM on day 0 and undergo stem cell mobilization with G-CSF on days 5 to 9 and apheresis for peripheral blood stem cell collection on days 10 to 14 per standard of care. Donors may optionally undergo blood sample collection on study. RECIPIENTS: Recipients undergo pre-transplant conditioning on days -60 to 0 and undergo HCT with the donor peripheral blood stem cells within 9 weeks of donor vaccination on day 0. Recipients undergo blood sample collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Biospecimen Collection

2004

Completed Phase 2

~1700

Granulocyte Colony-Stimulating Factor

2016

Completed Phase 2

~50

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,669 Previous Clinical Trials

40,926,185 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

567 Previous Clinical Trials

1,922,444 Total Patients Enrolled

Vaibhav AgrawalPrincipal InvestigatorCity of Hope Medical Center

1 Previous Clinical Trials

54 Total Patients Enrolled

Frequently Asked Questions

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

What potential risks do individuals face when receiving the Arm I (Triplex) vaccination?

"As a Phase 2 trial, there is evidence that Arm I (Triplex vaccination) possesses an adequate level of safety and thus earned a score of 2. However, no data exists to affirm its efficacy."

Answered by AI

Does this trial have the capacity to enroll participants at this time?

"Data posted on clinicaltrials.gov states that this medical experiment is not enrolling participants at the moment; it was initially shared on October 25th 2023 and its details were last altered September 22nd 23rd. Despite this, there are 5586 other trials currently searching for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

2024. "CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06059391.

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