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Clinical Development of a Cytomegalovirus DNA Vaccine: From Product Concept to Pivotal Phase 3 Trial

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Author(s): Larry R. Smith | Mary K. Wloch | Jennifer A. Chaplin | Michele Gerber | Alain P. Rolland

Journal: Vaccines
ISSN 2076-393X

Volume: 1;
Issue: 4;
Start page: 398;
Date: 2013;
Original page

Keywords: plasmid DNA vaccine | cytomegalovirus (CMV) | glycoprotein B (gB) | phosphoprotein 65 (pp65) | poloxamer CRL1005 | benzalkonium chloride (BAK) | hematopoietic cell transplant (HCT) | CMV end organ disease (EOD)

ABSTRACT
2013 marks a milestone year for plasmid DNA vaccine development as a first-in-class cytomegalovirus (CMV) DNA vaccine enters pivotal phase 3 testing. This vaccine consists of two plasmids expressing CMV antigens glycoprotein B (gB) and phosphoprotein 65 (pp65) formulated with a CRL1005 poloxamer and benzalkonium chloride (BAK) delivery system designed to enhance plasmid expression. The vaccine’s planned initial indication under investigation is for prevention of CMV reactivation in CMV-seropositive (CMV+) recipients of an allogeneic hematopoietic stem cell transplant (HCT). A randomized, double-blind placebo-controlled phase 2 proof-of-concept study provided initial evidence of the safety of this product in CMV+ HCT recipients who underwent immune ablation conditioning regimens. This study revealed a significant reduction in viral load endpoints and increased frequencies of pp65-specific interferon-γ-producing T cells in vaccine recipients compared to placebo recipients. The results of this endpoint-defining trial provided the basis for defining the primary and secondary endpoints of a global phase 3 trial in HCT recipients. A case study is presented here describing the development history of this vaccine from product concept to initiation of the phase 3 trial.
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