NCT01941056

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

PRIMARY OBJECTIVES: I. 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: I. 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.

Conditions

• Cytomegalovirus Infection
• Healthy, no Evidence of Disease

Interventions

Type	Name	Description
BIOLOGICAL	multi-CMV epitope modified vaccinia Ankara vaccine	Given IM
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2014-01-05
• Primary completion: 2017-07-28
• Completion: 2017-07-28
• First posted: 2013-09-13
• Last updated: 2017-08-02

Locations

1 site across 1 country: United States