NCT02103426

An Evaluation of a Cytomegalovirus (CMV) Vaccine (ASP0113) in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

A Phase 1, Single-Blind, Parallel-Group, Pharmacokinetic and Immunogenicity Study With ASP0113 in CMV-Seropositive and CMV-Seronegative Healthy Subjects and CMV-Seronegative Dialysis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Astellas Pharma Global Development, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine whether ASP0113 (a CMV deoxyribonucleic acid \[DNA\] vaccine) can be detected in plasma after intramuscular (IM) injections, and to determine whether CMV-seropositive healthy volunteers, CMV-seronegative healthy volunteers, CMV-seronegative dialysis patients mount an immune response to the CMV proteins produced by the vaccine after repeated ASP0113 IM injection.

Detailed description

Part 1 is open-label with no randomization, and Part 2 is single-blind and randomized. The purpose of Part 1 is to obtain pilot pharmacokinetic data so as to optimize pharmacokinetic sample collection times in Part 2.

Conditions

• Dialysis
• Healthy Subjects
• Cytomegalovirus Infection

Interventions

Type	Name	Description
DRUG	ASP0113	intramuscular injection
DRUG	Placebo	intramuscular injection

Timeline

• Start date: 2013-12-30
• Primary completion: 2016-05-10
• Completion: 2016-05-10
• First posted: 2014-04-03
• Last updated: 2024-10-17

Locations

4 sites across 1 country: United States