Multi-peptide CMV-Modified Vaccinia Ankara Vaccine for Cytomegalovirus (CMV)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Cytomegalovirus (CMV)+1 MoreMulti-peptide CMV-Modified Vaccinia Ankara Vaccine - Biological
Eligibility
1 - 21
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a CMV vaccine in children undergoing stem cell transplants to see if it is safe and effective.

Eligible Conditions
  • Cytomegalovirus (CMV)
  • Bone Marrow Transplant Recipient

Treatment Effectiveness

Study Objectives

5 Primary · 16 Secondary · Reporting Duration: Up to 1 year, rising CMV viremia or viremia >= 3,705

Day 365
Incidence of late CMV viremia
Year 1
Time-to viremia
Day 100
Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)
Up to 1 year
All-cause mortality
Chronic GVHD (cGVHD)
Cumulative number of CMV specific antiviral treatment days
Duration of viremia
Incidence of acute graft versus host disease (aGVHD)
Incidence of adverse events (Phase I)
Communicable Diseases
Perinatal death
Optimal dose (Phase I)
Relapse defined by bone marrow and/or imaging studies
Time to engraftment
Year 1
Kinetics of CMV-specific T cell immunity
Levels of CMV-specific T cell immunity
NK function (cytotoxicity and cytokine production)
Natural killer (NK) phenotype
Year 1
Use of antiviral drugs (triggered by rising CMV viremia or viremia >= 3,750 IU/ml)
Week 2
Incidence of grade 3-4 adverse events
Severe (grade 3-4) acute graft versus host disease (aGVHD)

Trial Safety

Side Effects for

Comparator TIV (6 to <72 Months)
18%Pyrexia
17%Upper respiratory tract infection
16%Diarrhea
14%Decreased appetite
13%Injection site pain
13%Irritability postvaccinal
12%Nasopharyngitis
10%Hypersomnia
8%Crying
7%Vomiting
7%Injection site erythema
6%Injection site hemorrhage
6%Gastroenteritis
5%Injection site induration
3%Injection site swelling
3%Headache
2%Fatigue
2%Myalgia
1%Pneumonia
1%Animal Bite
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01346592) in the Comparator TIV (6 to <72 Months) ARM group. Side effects include: Pyrexia with 18%, Upper respiratory tract infection with 17%, Diarrhea with 16%, Decreased appetite with 14%, Injection site pain with 13%.

Trial Design

1 Treatment Group

Supportive Care (multi-antigen CMV-modified vaccinia ankara)
1 of 1

Experimental Treatment

80 Total Participants · 1 Treatment Group

Primary Treatment: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine · No Placebo Group · Phase 1 & 2

Supportive Care (multi-antigen CMV-modified vaccinia ankara)Experimental Group · 2 Interventions: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine, Laboratory Biomarker Analysis · Intervention Types: Biological, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year, rising cmv viremia or viremia >= 3,705

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,077 Previous Clinical Trials
41,139,548 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
515 Previous Clinical Trials
2,248,000 Total Patients Enrolled
Anna PawlowskaPrincipal InvestigatorCity of Hope Medical Center
1 Previous Clinical Trials

Eligibility Criteria

Age 1 - 21 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Every person involved in the study (or their guardians) must be able to understand and agree to written consent; any child taking part in the study will need to assent as per the guidelines of the institution; if a non-English patient wishes to take part in the study, bilingual health services will be provided in the appropriate language whenever feasible.
A participant must be willing to comply with study and/or follow-up procedures, including being willing to be followed for one year post-HCT.
s, significantly improved leukemia-free survival outcomes in adult patients with first complete remission (CR) of acute myeloid leukemia (AML) compared with chemotherapy Allogeneic hematopoietic cell transplantation (allo-HCT) with high/intermediate resolution HLA donor allele matching increased leukemia-free survival outcomes in adult patients with first complete remission (CR) of acute myeloid leukemia (AML) compared with chemotherapy.
Females of childbearing potential and sexually active males must use contraception prior to study entry and for up to 90 days after HCT
The text tells us that people are allowed to have conditioning and immunosuppressive regimens according to the institutional guidelines.
A negative serum or urine beta-human chorionic gonadotropin (HCG) test within two weeks of registration is required for all female patients of childbearing potential.
The person has not been infected with the human immunodeficiency virus, the hepatitis C virus, or the hepatitis B virus and has tested negative for the presence of their DNA within the last two months.
The researchers plan to do a related, experimental transplant with a donor who shares three of six of the patient's HLA genes.