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Virus Therapy

CMV-MVA Triplex Vaccine for CMV Complications Post-Transplant

Phase 2

Waitlist Available

Led By Ryotaro Nakamura, MD

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-hct

Awards & highlights

Study Summary

This trial is studying a vaccine that may help reduce CMV complications in patients who have had the virus before and are having a donor hematopoietic cell transplant.

Who is the study for?

This trial is for patients with certain blood cancers or disorders who've had CMV and are undergoing a donor bone marrow transplant. They must understand the study, agree to follow-up procedures for a year, be willing to use contraception, and not have received specific treatments that affect the immune system or CMV within the last 6 months.Check my eligibility

What is being tested?

The trial tests if a vaccine made from weakened virus MVA carrying small pieces of CMV DNA can reduce complications from CMV in those getting bone marrow transplants. Participants will either get this experimental vaccine or a placebo to compare outcomes.See study design

What are the potential side effects?

Potential side effects may include typical reactions at the injection site like pain and swelling, flu-like symptoms such as fever and fatigue, allergic reactions, and possibly others depending on how individuals respond to vaccines.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Cytomegalovirus (CMV) Events to Day 100

Incidence of Severe (Grade 3-4) Acute Graft-Versus-Host Disease

Secondary outcome measures

All-cause Mortality

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (multi-peptide CMV-MVA vaccine)Experimental Treatment2 Interventions

Patients receive multi-peptide CMV-MVA vaccine IM on days 28 and 56 post-HCT.

Group II: Arm II (placebo)Placebo Group2 Interventions

Patients receive placebo IM on days 28 and 56 post-HCT.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Diavax BiosciencesUNKNOWN

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,051 Total Patients Enrolled

7 Trials studying Lymphadenopathy

323 Patients Enrolled for Lymphadenopathy

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,358 Total Patients Enrolled

1 Trials studying Lymphadenopathy

3 Patients Enrolled for Lymphadenopathy

Media Library

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02506933 — Phase 2

Lymphadenopathy Research Study Groups: Arm I (multi-peptide CMV-MVA vaccine), Arm II (placebo)

Lymphadenopathy Clinical Trial 2023: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine Highlights & Side Effects. Trial Name: NCT02506933 — Phase 2

Multi-peptide CMV-Modified Vaccinia Ankara Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02506933 — Phase 2

Frequently Asked Questions

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

Has the FDA sanctioned Laboratory Biomarker Analysis?

"Our experts at Power have assigned a score of 2 to the safety profile of Laboratory Biomarker Analysis, since this is still in Phase 2. This implies that while there are some studies supporting its security, none demonstrate efficacy yet."

Answered by AI

Is it currently feasible to join this research endeavor?

"According to data available on clinicaltrials.gov, this trial is no longer actively recruiting. The study was first made public in November 2015 and last updated in February 2022; however, there are still 3248 other trials requiring participants."

Answered by AI

Has Laboratory Biomarker Analysis been explored in the context of other clinical experiments?

"Laboratory Biomarker Analysis was first researched in 2015 at Dana-Farber Cancer Institute. As of now, 18914 clinical trials have concluded and 16 are still going on with a majority based out of Houston, Texas."

Answered by AI

Does my profile meet the criteria to join this experiment?

"This clinical trial is in search of 102 people with lymphadenopathy aged between 18 and 75. Notably, they will be expected to comply with study procedures for a year post-HCT. Furthermore, accepted applicants must meet the following criteria: being willing to sign an informed consent form; having Hodgkin/Non-Hodgkin Lymphoma, Myelodysplastic syndrome, Acute lymphoblastic leukemia or Chronic Myelogenous Leukaemia; not suffering from Multiple myeloma or Aplastic Anemia; have had no previous autologous HCTs and seropositive CMV ("

Answered by AI

Is the age requirement for participation in this trial restricted to those over 25?

"This trial has specific requirements for participant age, with people aged 18-75 being eligible. For those under the age of 18 or over 65 years old, there are 691 and 2823 studies respectively available."

Answered by AI

How many subjects are currently participating in this research endeavor?

"As of February 17th, 2022 this research study is not recruiting any new candidates. Initially posted on November 5th, 2015 the most recent update was done in early 2021. For those who are seeking other medical trials, there are 3232 studies with lymphadenopathy and 16 for laboratory biomarker analysis that currently have open recruitment periods."

Answered by AI

Recent research and studies

Annals of Internal MedicineJournal

Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients

Aldoss, Ibrahim, Corinna La Rosa, Lindsey R. Baden, Jeffrey Longmate, Ella J. Ariza-Heredia, Wasima N. Rida, Chetan Raj Lingaraju, et al.. 2020. “Poxvirus Vectored Cytomegalovirus Vaccine to Prevent Cytomegalovirus Viremia in Transplant Recipients”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m19-2511.

BloodJournal

MVA Vaccine Encoding CMV Antigens Safely Induces Durable Expansion of Cmv-specific T Cells in Healthy Adults

La Rosa, Corinna, Jeff Longmate, Joy Martinez, Qiao Zhou, Teodora I. Kaltcheva, Weimin Tsai, Jennifer Drake, et al.. 2017. “MVA Vaccine Encoding CMV Antigens Safely Induces Durable Expansion of Cmv-specific T Cells in Healthy Adults”. Blood. American Society of Hematology. doi:10.1182/blood-2016-07-729756.

clinicaltrials.govStudy

Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant

2015. "Multi-antigen CMV-MVA Triplex Vaccine in Reducing CMV Complications in Patients Previously Infected With CMV and Undergoing Donor Hematopoietic Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02506933.

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