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Cancer Vaccine

CMV Vaccine for Bone Marrow Transplant Recipients

Phase 1 & 2
Recruiting
Led By Anna Pawlowska
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
Planned allogenic (allo)-HCT, with 9/10 or 10/10 (A, B, C, DRB1, DQB1) high/intermediate resolution HLA donor allele matching and with no T-cell depletion of graft
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year, rising cmv viremia or viremia >= 3,705
Awards & highlights

Study Summary

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

Who is the study for?
This trial is for pediatric patients with cytomegalovirus (CMV) who are about to receive a donor stem cell transplant. They must be HIV, HCV negative and HBV DNA negative if previously exposed. Participants need to agree to use contraception and follow the study for one year post-transplant. It's not open to those on recent anti-CMV therapy, with congenital immune deficiencies, active autoimmune conditions needing immunosuppression (except aplastic anemia), or unable to comply with study procedures.Check my eligibility
What is being tested?
The trial is testing a multi-antigen CMV-modified vaccinia ankara vaccine in children undergoing stem cell transplants. The aim is to find the safest dose that works best at helping these young patients resist life-threatening complications from CMV after their transplant.See study design
What are the potential side effects?
Possible side effects of the CMV vaccine may include typical reactions seen with other vaccines such as pain at injection site, fever, fatigue, headache and potential allergic reactions. Since this is investigational, there may be unknown risks which will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a stem cell transplant with a closely matched donor and without T-cell removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year, rising cmv viremia or viremia >= 3,705
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year, rising cmv viremia or viremia >= 3,705 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 (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)
Incidence of adverse events (Phase I)
Incidence of grade 3-4 adverse events
+2 more
Secondary outcome measures
All-cause mortality
Chronic GVHD (cGVHD)
Cumulative number of CMV specific antiviral treatment days
+13 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Upper respiratory tract infection
14%
Decreased appetite
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

1Treatment groups
Experimental Treatment
Group I: Supportive Care (multi-antigen CMV-modified vaccinia ankara)Experimental Treatment2 Interventions
Patients receive multi-antigen CMV-modified vaccinia ankara vaccine IM on days 28 and 56 post-HCT.

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,172 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,755 Total Patients Enrolled
Anna PawlowskaPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
20 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 findings have been reported regarding the efficacy of Multi-peptide CMV-Modified Vaccinia Ankara Vaccine?

"Currently, 16 clinical trials are underway to evaluate the efficacy of Multi-peptide CMV-Modified Vaccinia Ankara Vaccine; 0 of them have entered Phase 3. The majority of those studies take place in Boston, MA, but 75 other locations across the US and abroad have active investigation sites for this vaccine."

Answered by AI

Is it possible for me to join this experiment?

"This clinical trial requires 80 child participants aged between 1 and 21 who have undergone hematopoietic cell transplantation. In order to be eligible, the participants must conform to a set of criteria: they should demonstrate willingness to comply with study/follow-up procedures for one year post HCT; females of potential-childbearing age, as well as sexually active males, need to use an effective contraceptive (hormonal or barrier method) from pre-study entry till 90 days after HCT; in case there is suspicion of pregnancy during the course of the trial, the treating physician ought to be informed immediately; conditioned and immunos"

Answered by AI

Are individuals over the age of 85 excluded from this investigation?

"To be permitted to join this trial, patients must fall between one year and twenty-one years in age. This clinical study has 26 spots available for younger participants and 51 positions open to those over 65."

Answered by AI

To what extent is the participant pool growing for this analysis?

"Affirmative, the information hosted on clinicaltrials.gov confirms that this medical experiment is currently recruiting patients. It was first posted on May 11th 2018 and last updated on June 14th 2022. The trial necessitates 80 people from a single location to participate in it."

Answered by AI

Is this investigation presently open to new participants?

"Affirmative. According to clinicaltrials.gov, this study is actively recruiting participants with the listing first published on May 11th 2018 and last updated June 14th 2022. Eighty candidates must be sourced from one medical centre."

Answered by AI
~7 spots leftby Nov 2024