Cytomegaloviral InfectionPhase 1/2NCT03354728
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Treating Pediatric Patients With Positive Cytomegalovirus Undergoing Donor Stem Cell Transplant
A Phase 1/2 study testing Laboratory Biomarker Analysis and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine in people with Cytomegaloviral Infection and Hematopoietic Cell Transplant Recipient, run by City of Hope Medical Center at 1 site in United States.
Trial summary
This phase I/II trial studies the side effects and best dose of multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric patients with positive cytomegalovirus who are undergoing donor stem cell transplant. Read more about this study
- Who is it for?
- Ages 1 year to 21 years
- Conditions the study is for
- Cytomegaloviral Infection, Hematopoietic Cell Transplant Recipient
- What is being tested?
- Laboratory Biomarker Analysis and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 11 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All subjects (or their guardians) must have the ability to understand and the willingness to sign a written informed consent; age appropriate assent will be obtained per institutional guidelines; to allow non-English patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible
- Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
- 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
- Planned related HCT with molecular 3/6 HLA donor allele matching (haploidentical) (for phase I only)
- CMV seropositive at the time of HCT
- Conditioning and immunosuppressive regimens according to institutional guidelines are permitted
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- Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient of childbearing potential only) within two weeks of registration
- Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV); if hepatitis B virus (HBV) core seropositive, absence of HBV deoxyribonucleic acid (DNA) within 2 months of registration
- Agreement by females of childbearing potential and sexually active males to use an effective method of contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
Who cannot join
- TRANSPLANT RELATED CRITERIA: Patients undergoing cord blood transplant (CB-HCT)
- Any prior investigational CMV vaccine
- Anti-CMV therapy in the last 6 months
- Live attenuated vaccines
- Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccine (e.g. influenza, pneumococcal)
- Allergy treatment with antigens injections
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- Alemtuzumab, cyclophosphamide, ATG or any equivalent in vivo T-cell depleting agent; Note: Pre-transplant ATG is permitted
- Antiviral medications with known therapeutic effects on CMV such as ganciclovir (GCV)/valine (VAL), FOS, Cidofovir, CMX-001, maribavir; acyclovir has no known therapeutic efficacy against CMV and is allowable as standard of care to prevent herpes simplex virus (HSV)
- Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment; intravenous immunoglobulin therapy (IVIG) is allowed
- Other investigational product-concurrent enrollment in other clinical trials using any investigational new drug (IND) drugs with unknown effects on CMV or with unknown toxicity profiles is prohibited
- Other medications that might interfere with the evaluation of the investigational product
- Patients with congenital immune deficiency
- Patients with active autoimmune conditions requiring systemic immunosuppressive therapy within the previous 5 years are not eligible, the exception to this is patients with aplastic anemia, who are eligible
- Pregnant women and women who are lactating; CMV-MVA Triplex risks to pregnant women are unknown; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the administered vaccine, also breastfeeding should be discontinued if the mother is enrolled on this study
- Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc
- Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issue related to feasibility/logistics)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Anna B. Pawlowska, 626-301-8442, apawlows@coh.org
Anna B. Pawlowska
About this study
Official title: A Phase 1/2 Clinical Study to Evaluate the Optimal Dose and the Protective Effect of CMV-MVA Triplex Vaccine in Pediatric Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
This phase I/II trial studies the side effects and best dose of multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric patients with positive cytomegalovirus who are undergoing donor stem cell transplant. Multi-antigen CMV-modified vaccinia ankara vaccine may help people resist CMV life-threatening complications.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the optimal dose of multi-antigen CMV-modified vaccinia ankara vaccine (Triplex) in CMV-positive pediatric patients receiving human leukocyte antigen (HLA) matched, mismatched, or haploid-identical hematopoietic cell transplantation (HCT). (Phase I) II. To evaluate the safety profile of Triplex in this patient population. (Phase I) III. To determine if Triplex reduces the frequency of CMV events when compared to historical data. (Phase II)
SECONDARY OBJECTIVES:
- To characterize CMV reactivation and disease by assessing: time to CMV reactivation, duration of viremia, recurrence of viremia, incidence of late CMV viremia/disease (defined as > 100 days and =< 365 days post HCT), use of anti-viral drugs triggered by rising CMV viremia or viremia >= 3750 IU/mL, cumulative number of CMV specific antiviral treatment days.
II. To evaluate the impact of Triplex on transplant related outcomes by assessing the incidence of acute and chronic graft versus host disease (GVHD), relapse, non-relapse mortality (NRM), all-cause mortality, infections.
III. To investigate the impact of Triplex on cellular immunity by investigating: the level, function and kinetics of CMV-specific T-cell immunity, the changes in adaptive natural killer (NK) cell population and highly cytotoxic memory NKG2C+ NK cells, and changes in GVHD biomarkers.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive multi-antigen CMV-modified vaccinia ankara vaccine intramuscularly (IM) on days 28 and 56 post-HCT.
After completion of study treatment, patients are followed up for up to 270 or 365 days.
- Being tested
- Laboratory Biomarker Analysis, Multi-peptide CMV-Modified Vaccinia Ankara Vaccine
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Multi-peptide CMV-Modified Vaccinia Ankara VaccineBiological
Also called CMV-MVA Triplex Vaccine, Multi-antigen CMV-Modified Vaccinia Ankara Vaccine
Given IM
| Study group | Role | What they receive |
|---|---|---|
| Supportive Care (multi-antigen CMV-modified vaccinia ankara) | Experimental | Patients receive multi-antigen CMV-modified vaccinia ankara vaccine IM on days 28 and 56 post-HCT. Receives: Other: Laboratory Biomarker Analysis; Biological: Multi-peptide CMV-Modified Vaccinia Ankara Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose (Phase I)
Measured: Up to 1 year
Incidence of adverse events (Phase I)
Adverse events will be characterized using the descriptions and grading scales according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Measured: Up to 1 year
Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)
Will be assessed with exact 90% confidence bounds.
Measured: Prior to day 100 post-hematopoietic cell transplantation (HCT) or viremia treated by anti-viral therapy, or detection of CMV by histology
Non-relapse mortality
Will be compared to historical controls at the final analysis, and a 90% lower confidence bound on the difference in 12-month event free survival will be produced.
Measured: At 100 days post-HCT
Severe (grade 3-4) acute graft versus host disease (aGVHD)
Measured: Within 2 weeks from each vaccination
Incidence of grade 3-4 adverse events
Will be graded per CTCAE version 4.0.
Measured: Within 2 weeks from each vaccination
Secondary outcomes (16)
Time-to viremia
Measured: Number of days from transplant to the date of > 1250 IU/mL, assessed up to 1 year
Duration of viremia
Measured: Up to 1 year
Incidence of late CMV viremia
Measured: > 100 and =< 365 days post-HCT
Use of antiviral drugs (triggered by rising CMV viremia or viremia >= 3,750 IU/ml)
Measured: Up to 1 year, rising CMV viremia or viremia >= 3,705
Cumulative number of CMV specific antiviral treatment days
Measured: Up to 1 year
Time to engraftment
Measured: Up to 1 year
Incidence of acute graft versus host disease (aGVHD)
Measured: Up to 1 year
Chronic GVHD (cGVHD)
Measured: Up to 1 year
Relapse defined by bone marrow and/or imaging studies
Measured: Up to 1 year
Non-relapse mortality
Measured: Up to 1 year
All-cause mortality
Measured: Up to 1 year
Infections
Measured: Up to 1 year
Levels of CMV-specific T cell immunity
Will be combined with immunophenotyping and functional studies. The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale, using a generalized estimating equation approach to accommodate the stochastic dependence through time. This produces an estimated multiplicative effect of vaccination, qualified by a valid estimate of variability.
Measured: Up to 1 year post-HCT
Kinetics of CMV-specific T cell immunity
The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale, using a generalized estimating equation approach to accommodate the stochastic dependence through time. This produces an estimated multiplicative effect of vaccination, qualified by a valid estimate of variability.
Measured: Up to 1 year post-HCT
Natural killer (NK) phenotype
The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale.
Measured: Up to 1 year post-HCT
NK function (cytotoxicity and cytokine production)
The data analysis for estimating the effect of vaccination on cellular immunity will necessarily be more exploratory in nature. The longitudinal CMV-specific cellular assay data will be modeled on a logarithmic scale, using a generalized estimating equation approach to accommodate the stochastic dependence through time. This produces an estimated multiplicative effect of vaccination, qualified by a valid estimate of variability.
Measured: Up to 1 year post-HCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study start31 Aug 2018
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegaloviral InfectionStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Anna Pawlowska, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354728
- Sponsor's protocol ID
- 17236
- Other IDs
- NCI-2017-02046, 17236
- Status last verified
- Oct 2026
- First submitted
- 6 Nov 2017
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Clinical Study to Evaluate the Optimal Dose and the Protective Effect of CMV-MVA Triplex Vaccine in Pediatric Patients Receiving an Allogeneic Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03354728
- Acronym / sponsor ID
- 17236
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects and best dose of multi-antigen cytomegalovirus (CMV)-modified vaccinia ankara vaccine and to see how well it works in treating pediatric patients with positive cytomegalovirus who are undergoing donor stem cell transplant. Multi-antigen CMV-modified vaccinia ankara vaccine may help people resist CMV life-threatening complications.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the optimal dose of multi-antigen CMV-modified vaccinia ankara vaccine (Triplex) in CMV-positive pediatric patients receiving human leukocyte antigen (HLA) matched, mismatched, or haploid-identical hematopoietic cell transplantation (HCT). (Phase I) II. To evaluate the safety profile of Triplex in this patient population. (Phase I) III. To determine if Triplex reduces the frequency of CMV events when compared to historical data. (Phase II)
SECONDARY OBJECTIVES:
- To characterize CMV reactivation and disease by assessing: time to CMV reactivation, duration of viremia, recurrence of viremia, incidence of late CMV viremia/disease (defined as > 100 days and =< 365 days post HCT), use of anti-viral drugs triggered by rising CMV viremia or viremia >= 3750 IU/mL, cumulative number of CMV specific antiviral treatment days.
II. To evaluate the impact of Triplex on transplant related outcomes by assessing the incidence of acute and chronic graft versus host disease (GVHD), relapse, non-relapse mortality (NRM), all-cause mortality, infections.
III. To investigate the impact of Triplex on cellular immunity by investigating: the level, function and kinetics of CMV-specific T-cell immunity, the changes in adaptive natural killer (NK) cell population and highly cytotoxic memory NKG2C+ NK cells, and changes in GVHD biomarkers.
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
Patients receive multi-antigen CMV-modified vaccinia ankara vaccine intramuscularly (IM) on days 28 and 56 post-HCT.
After completion of study treatment, patients are followed up for up to 270 or 365 days.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive Care (multi-antigen CMV-modified vaccinia ankara) | Experimental | Other: Laboratory Biomarker Analysis, Biological: Multi-peptide CMV-Modified Vaccinia Ankara VaccinePatients receive multi-antigen CMV-modified vaccinia ankara vaccine IM on days 28 and 56 post-HCT. |
Who may qualify
- Ages
- 1 year to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- All subjects (or their guardians) must have the ability to understand and the willingness to sign a written informed consent; age appropriate assent will be obtained per institutional guidelines; to allow non-English patients to participate in this study, bilingual health services will be provided in the appropriate language when feasible
- Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT
- 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
- Planned related HCT with molecular 3/6 HLA donor allele matching (haploidentical) (for phase I only)
- CMV seropositive at the time of HCT
Key exclusion criteria (16 listed)
- TRANSPLANT RELATED CRITERIA: Patients undergoing cord blood transplant (CB-HCT)
- Any prior investigational CMV vaccine
- Anti-CMV therapy in the last 6 months
- Live attenuated vaccines
- Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccine (e.g. influenza, pneumococcal)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Supportive Care (multi-antigen CMV-modified vaccinia ankara) |
| Multi-peptide CMV-Modified Vaccinia Ankara VaccineAlso: CMV-MVA Triplex Vaccine, Multi-antigen CMV-Modified Vaccinia Ankara VaccineGiven IM | Biological | Supportive Care (multi-antigen CMV-modified vaccinia ankara) |
Primary outcome
Optimal dose (Phase I)
Time frame: Up to 1 year
Incidence of adverse events (Phase I)
Time frame: Up to 1 year
Adverse events will be characterized using the descriptions and grading scales according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Cytomegalovirus (CMV) events (reactivation >= 1250 IU/mL), or viremia treated by anti-viral therapy, or detection of CMV by histology (Phase II)
Time frame: Prior to day 100 post-hematopoietic cell transplantation (HCT) or viremia treated by anti-viral therapy, or detection of CMV by histology
Will be assessed with exact 90% confidence bounds.
Non-relapse mortality
Time frame: At 100 days post-HCT
Will be compared to historical controls at the final analysis, and a 90% lower confidence bound on the difference in 12-month event free survival will be produced.
Severe (grade 3-4) acute graft versus host disease (aGVHD)
Time frame: Within 2 weeks from each vaccination
Incidence of grade 3-4 adverse events
Time frame: Within 2 weeks from each vaccination
Will be graded per CTCAE version 4.0.
16 secondary outcomes
Time-to viremia
Time frame: Number of days from transplant to the date of > 1250 IU/mL, assessed up to 1 year
Duration of viremia
Time frame: Up to 1 year
Incidence of late CMV viremia
Time frame: > 100 and =< 365 days post-HCT
Use of antiviral drugs (triggered by rising CMV viremia or viremia >= 3,750 IU/ml)
Time frame: Up to 1 year, rising CMV viremia or viremia >= 3,705
Cumulative number of CMV specific antiviral treatment days
Time frame: Up to 1 year
Time to engraftment
Time frame: Up to 1 year
Incidence of acute graft versus host disease (aGVHD)
Time frame: Up to 1 year
Chronic GVHD (cGVHD)
Time frame: Up to 1 year
Relapse defined by bone marrow and/or imaging studies
Time frame: Up to 1 year
Non-relapse mortality
Time frame: Up to 1 year
All-cause mortality
Time frame: Up to 1 year
Infections
Time frame: Up to 1 year
Levels of CMV-specific T cell immunity
Time frame: Up to 1 year post-HCT
Kinetics of CMV-specific T cell immunity
Time frame: Up to 1 year post-HCT
Natural killer (NK) phenotype
Time frame: Up to 1 year post-HCT
NK function (cytotoxicity and cytokine production)
Time frame: Up to 1 year post-HCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anna Pawlowska principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Laboratory Biomarker Analysis and Multi-peptide CMV-Modified Vaccinia Ankara Vaccine in people with Cytomegaloviral Infection and Hematopoietic Cell Transplant Recipient, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal dose (Phase I) (time frame: Up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.