Cytomegalovirus Infection Clinical Trial
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.
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.
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