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Cytomegalovirus InfectionPhase 1NCT01941056

Vaccine Therapy in Healthy Volunteers With or Without Previous Exposure to Cytomegalovirus

A Phase 1 study testing multi-CMV epitope modified vaccinia Ankara vaccine and laboratory biomarker analysis in people with Cytomegalovirus Infection and Healthy, no Evidence of Disease, run by City of Hope Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial studies the side effects and the best dose of vaccine therapy in healthy volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a gene-modified virus may help the body build an immune response and may help prevent cytomegalovirus infection. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
multi-CMV epitope modified vaccinia Ankara vaccine and laboratory biomarker analysis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
5 Jan 2014to 28 Jul 2017
Phase
Phase 1
Are there results?
None posted in the registry

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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Sodium range from within normal institutional limits to less than a grade I toxicity
  • Potassium range from within normal institutional limits to less than a grade I toxicity
  • Chloride range from within normal institutional limits to less than a grade I toxicity
  • Carbon dioxide range from within normal institutional limits to less than a grade I toxicity
  • Glucose range from within normal institutional limits to less than a grade I toxicity
  • Alkaline phosphatase (AP) range from within normal institutional limits to less than a grade I toxicity
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  • Aspartate aminotransferase (AST), alanine aminotransferase (ALT) range from within normal institutional limits to less than a grade I toxicity
  • Blood urea nitrogen (BUN) range from within normal institutional limits to less than a grade I toxicity
  • Creatinine range from within normal institutional limits to less than a grade I toxicity
  • Lactic dehydrogenase (LDH) range from within normal institutional limits to less than a grade I toxicity
  • Total bilirubin range from within normal institutional limits to less than a grade I toxicity
  • Uric acid range from within normal institutional limits to less than a grade I toxicity
  • Albumin > lower limit of normal institutional limits
  • White blood count range from within normal institutional limits to less than a grade I toxicity
  • Hemoglobin (HGB) range from within normal institutional limits to less than a grade I toxicity
  • Hematocrit (HCT) range from within normal institutional limits to less than a grade I toxicity
  • Platelet count is within the lower limit of normal institutional limits and not more than 1.5 times the upper limit of normal institutional limits
  • Hepatitis B virus (HBV) surface antigen negative and hepatitis C virus (HCV) seronegative; human immunodeficiency virus (HIV)-1 seronegative
  • Currently not taking daily medications for chronic or intercurrent illness; those medications which are excepted from this rule are thyroid replacement, estrogen replacement, dietary vitamins and protein supplements, and any medications not known or likely to be immunosuppressive, as determined by the principal investigator (PI)
  • No surgery in past 6 months which required general anesthesia, but minor procedures, such as dental surgery and superficial diagnostic biopsies, are permitted
  • No diagnosis which has been associated with immunodeficiency
  • No active infection for which the subject is receiving treatment
  • Framingham Risk Score for cardiovascular disease =< 10%; no history of heart disease, e.g. previous treated arrhythmia or myocardial infarction; no horizontal positioning-induced or activities of normal living exercise-induced shortness of breath; no history of stroke or claudication; no current treatment with medication for high cholesterol or other lipid abnormality; a documented electrocardiogram (ECG) and cardiac troponin must be within normal institutional limits in the past 30 days; "normal ECG with sinus tachycardia" or " normal ECG with sinus bradycardia" is allowable based on a history of absent cardiac/exercise related symptoms as determined by the P.I. in consultation with a senior staff cardiologist
  • No history of or prior treatment for diabetes type 1 or diabetes type 2
  • Women of childbearing age must have a negative urine pregnancy test and must not be planning to become pregnant within the next 6 months
  • No history of adverse events with a prior smallpox vaccination
  • SECONDARY ELIGIBILITY CRITERIA:
  • It is anticipated that there could be a delay of 1-3 months between screening and actual vaccination; alternatively, there could be a delay due to availability of the vaccine; therefore, prior to registration for vaccination, the following secondary eligibility criteria must be met:
  • If not tested in past 4 months, serum chemistries and blood counts are within normal limits; hepatitis B virus (HBV) surface antigen negative and hepatitis C virus (HCV) seronegative; HIV-1 antibody negative
  • Women of childbearing age must have a urine pregnancy test performed within 48 hours of each vaccine administration with a negative result
  • Laboratory values prior to booster injection may include grade 1 laboratory abnormalities, but any grade >= grade 2 will exclude the subject from a booster injection

Who cannot join

  • Any previous condition, or one that becomes known during the screening period, that would suggest that the individual could be immunologically impaired, or for which this study would pose a danger to him/herself or about which the P.I., in evaluating the subject for eligibility, determines that this exclusion is appropriate
  • Subjects are excluded who have a history of cancer other than basal cell skin cancer, or any condition, psychiatric or otherwise, that would preclude informed consent, consistent follow-up or compliance with any aspect of the study (e.g., untreated schizophrenia or other significant cognitive impairment, etc. as determined by the PI. In addition, allergic diatheses as define by a history of asthma, anaphylaxis, or generalized urticaria, or by daily use of antihistamines, episodic (more than once in past 3 months) inhalational medications including steroidal agents, non-steroidal agents, or cromolyn sodium
  • Subjects with severe migraine headaches (more than one per month on average in the past 6 months or requiring preventive medications) are excluded
  • Any of the following cardiac findings of ECG abnormality:
  • Conduction disturbance (complete left or right bundle branch block, intraventricular conduction disturbance with QRS > 120 ms, atrioventricular block [AV] block of any degree, and corrected QT [QTc] prolongation > 450 msec for men and > 460 msec for women)
  • Repolarization (ST segment or T wave) abnormality
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  • Significant atrial or ventricular arrhythmia, including frequent ectopy (e.g., 2 premature ventricular contractions in a row; and
  • Evidence of past myocardial infarction
  • Any previous condition, or one that becomes known during the screening period, that would suggest that the technicians and health professionals involved in the study would be exposed to specific infectious risk
  • Treatment with whole or subunit CMV or poxvirus vaccine in the last 12 months
  • Men with partners of child-bearing potential and women of child-bearing potential who are not willing to use medically effective birth control methods, e.g. contraceptive pill, condom, or diaphragm, and continue this for 6 weeks after the second and last dose of vaccine
  • Subjects who have had a live vaccine =< 30 days prior to administration of study vaccine or subjects who are =< 2 weeks within administration of inactivated vaccines (e.g. influenza vaccine)
  • Persons who are employed by or are a student at City of Hope and are in a chain of command that reports directly to persons listed on the protocol as Principal Investigator or Co-Investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • City of Hope Medical Center

    Duarte, California, 91010

Other trials in United States

About this study

Official title: Phase I Evaluation of a CMV-MVA Triplex Vaccine: Safety and Biologically Effective Dose in Healthy Volunteers With or Without Prior Immunity to CMV and Vaccinia

This phase I trial studies the side effects and the best dose of vaccine therapy in healthy volunteers with or without previous exposure to cytomegalovirus. Vaccines made from a gene-modified virus may help the body build an immune response and may help prevent cytomegalovirus infection.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To establish a biological optimal dose of the cytomegalovirus (CMV)-modified vaccinia Ankara (MVA) Triplex vaccine (multi-CMV epitope modified vaccinia Ankara vaccine).

II. To determine if the vaccine is safe and well tolerated in healthy volunteers at these doses.

SECONDARY OBJECTIVES:

  1. To provide preliminary evidence of CMV-MVA Triplex vaccine driven expansion of CMV-specific immune responses that would support further evaluation of this vaccine in hematopoietic cell transplantation (HCT) recipients.

II. To confer CMV-specific immunity to CMV-negative volunteers and to determine the duration of immune enhancement of CMV-specific cell mediated immunity (CMI) function up to 12 months following immunization of healthy volunteers.

OUTLINE: This is a dose-escalation study.

Participants receive multi-CMV epitope modified vaccinia Ankara vaccine intramuscularly (IM) followed by a booster injection 28 days later in the absence of unacceptable toxicity.

After completion of study treatment, participants are followed up for 12 months.

Being tested
multi-CMV epitope modified vaccinia Ankara vaccine, laboratory biomarker analysis
Medical subject headings
Cytomegalovirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multi-CMV epitope modified vaccinia Ankara vaccineBiological

    Also called CMV-MVA triplex vaccine

    Given IM

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT01941056
Study groupRoleWhat they receive
Treatment (CMV-MVA Triplex vaccine)ExperimentalParticipants receive multi-CMV epitope modified vaccinia Ankara vaccine IM followed by a booster injection 28 days later in the absence of unacceptable toxicity.
Receives: Biological: multi-CMV epitope modified vaccinia Ankara vaccine; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Successful completion of 2 injections without dose-limiting toxicity (DLT) according to the Division of Microbiology and Infectious Diseases (DMID) adult toxicity tables

    Measured: Up to 28 days

Secondary outcomes (2)

  1. Evidence of CMV-MVA Triplex vaccine driven expansion of CMV-specific immune responses to support further evaluation of this vaccine in HCT recipients.

    Expansion of CMV-specific T-cells in peripheral blood mononuclear cell (PBMC)will be evaluated by flow cytometry, immunocytochemistry (ICC) assays, and enzyme-linked immunosorbent spot (ELISPOT)

    Measured: Up to 1 year

  2. Frequency of polyfunctional cluster of differentiation (CD)4+ and CD8+ T cells recognizing CMV Ag, expressed as concentrations

    A one-sample signed-rank test will be used to compare pre- and post-vaccination CD4+ and CD8+ T cell levels. A secondary analysis will model cell concentrations as a function of time, dose, and CMV serostatus. Mixed models and generalized estimating equations will be used to permit quantitative estimation and flexible investigation of potentially interacting covariables.

    Measured: Up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2013 (estimated)
  2. Study start5 Jan 2014
  3. Primary completion28 Jul 2017
  4. Study completion28 Jul 2017

Resources

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
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01941056
Sponsor's protocol ID
08173
Other IDs
NCI-2013-01625, 08173, R01CA077544
Status last verified
Jul 2017
First submitted
5 Sep 2013
Last updated
2 Aug 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing multi-CMV epitope modified vaccinia Ankara vaccine and laboratory biomarker analysis in people with Cytomegalovirus Infection and Healthy, no Evidence of Disease, 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 31 inclusion and 13 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: finished, as of the sponsor's last update on 2 Aug 2017. 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 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.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Successful completion of 2 injections without dose-limiting toxicity (DLT) according to the Division of Microbiology and Infectious Diseases (DMID) adult toxicity tables (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01941056.

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 2 Aug 2017.

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