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Clinical Trials

Date: 2015-04-21

Type of information: Presentation of results at a congress

phase: preclinical

Announcement: presentation of results at the 5th International Congenital CMV Conference

Company: Vical (USA - CA)

Product: Vaxfectin®

Action mechanism:

adjuvant/lipid. Vaxfectin® is a novel proprietary cationic lipid-based formulation that has been shown to effectively enhance both plasmid DNA-based vaccines as well as protein--based vaccines. It is a commixture of a cationic lipid (GAP-DMORIE) and a neutral phospholipid (DPyPE) which, when combined in an aqueous vehicle, self-assemble to form liposomes.

Vaxfectin® was identified through an extensive screening of 100 different lipids, then optimized through an in vitro and in vivo development process, and finally validated through numerous studies using a wide variety of infectious disease models (including anthrax, HIV, influenza, malaria, measles, rabies, and tuberculosis). It has been extensively documented to enhance both antibody and cellular immune responses to vaccines and to provide enhanced protection in disease challenge models. Importantly, Vaxfectin®-adjuvanted vaccines have advanced into several clinical trials and have shown promising safety and immunogenicity profiles.

Vical is developing several products that utilize Vaxfectin® as an adjuvant. These include CyMVectinTM, our prophylactic vaccine against cytomegalovirus infection, and our therapeutic vaccine against herpes simplex type-2 infection. 

 

Disease:

congenital cytomegalovirus infection

Therapeutic area: Infectious diseases

Country:

Trial details:

Latest news:

* On April 21, 2015, Vical announced that Michael McVoy, Ph.D., Professor of Pediatrics at Virginia Commonwealth University, presented data from preclinical studies testing several combinations of Vaxfectin®- formulated glycoprotein-B (gB)-encoding DNA vaccines for neutralizing antibody responses. The data were featured at the 5th International Congenital CMV Conference held April 20-24, 2015, in Brisbane, Australia. Vaxfectin® is Vical\'s novel, proprietary cationic lipid-based adjuvant and is used in CyMVectin™, the company\'s congenital CMV vaccine candidate. The studies found that vaccines encoding gB provided both fibroblast and epithelial entry neutralizing titers that were comparable to those observed in sera from humans with naturally-acquired CMV infections. The data suggest that CyMVectin has the potential to induce neutralizing antibodies against a broad range of cells.

 

 

Is general: Yes