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

NCT01941056 | Completed Phase 1 DMC

• 3 other identifiers: 08173NCI-2013-01625R01CA077544
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cytomegalovirus Infection; Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

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

  Up to 28 days

Secondary Outcomes (2)

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

  Up to 1 year

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

  Up to 1 year

Study Arms (1)

Treatment (CMV-MVA Triplex vaccine)

EXPERIMENTAL

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

Biological: multi-CMV epitope modified vaccinia Ankara vaccine; Other: laboratory biomarker analysis

Interventions

multi-CMV epitope modified vaccinia Ankara vaccine BIOLOGICAL

Given IM

Also known as: CMV-MVA triplex vaccine

Treatment (CMV-MVA Triplex vaccine)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (CMV-MVA Triplex vaccine)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• John Zaia

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2013
• First Posted: September 13, 2013
• Study Start: January 5, 2014
• Primary Completion: July 28, 2017
• Study Completion: July 28, 2017
• Last Updated: August 2, 2017

Record last verified: 2017-07

Locations

US (1)