Herpes Vaccine Candidate Fails in Clinical Trial

Cytomegalovirus is a herpes virus estimated to infect 50 percent of adults by age 40
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(Precision Vaccinations News)

Astellas announced that ASP0113, an investigational DNA vaccine being developed for cytomegalovirus (CMV)-seropositive hematopoietic stem cell transplant (HSCT) recipients, did not meet its primary or secondary endpoints in the Phase 3 clinical trial

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CMV is a herpes virus that is estimated to infect more than half of all adults in the United States by age 40, says the Centers for Disease Control and Prevention (CDC).

Once CMV is in a person’s body, it stays there for life and can reactivate.

A healthy immune system typically protects an infected person against CMV disease but does not prevent or clear latent infection.

Individuals whose immune systems are not fully functional are at high risk of CMV reactivation, potentially leading to severe illness or death, reports the CDC.

Those at greatest risk include HCT and solid-organ transplant recipients, as well as infants born to mothers who first become infected during pregnancy.

The most commonly reported adverse event of this clinical trial was injection-site reactions.

Efficacy was assessed using a primary composite endpoint of overall mortality and CMV end-organ disease through the first year following the transplant.

This endpoint was not met.

Secondary endpoints of time to first protocol-defined CMV viremia and time to first use of adjudicated CMV-specific antiviral therapy also were not met.

ASP0113 is a bivalent DNA vaccine encoding CMV phosphoprotein 65 and glycoprotein B antigens for induction of both cellular and humoral immune responses, formulated with a proprietary poloxamer-based delivery system.

ASP0113 was initially developed by Vical which partnered with Astellas for further development and commercialization. ASP0113 received Orphan Drug Designation in the United States and Europe.

 

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