NCT01502345

Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines

Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines, pWRG/HTN-M(x) and pWRG/PUU-M(s2), for Prevention of Hemorrhagic Fever With Renal Syndrome Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is: • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device Secondary: • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.

Detailed description

The study will enroll 3 randomized groups of 9 subjects each, along with 3 alternates, for a total of 30 subjects. The study will include one group of subjects injected with the HTNV DNA vaccine, one group injected with the PUUV DNA vaccine, and one group injected with both HTNV and PUUV DNA vaccines (mixed), administered with the Ichor TDS-IM device. Subjects will receive one dose of vaccine on Days 0, 28, and 56 and will be followed until Day 240. Subjects will complete post-injection memory aids for 14 days after each injection. Subjects will be evaluated for safety and immune response throughout the study.

Conditions

• Hemorrhagic Fever With Renal Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	Vaccine/device combination for prevention of HFRS	PUUV DNA Vaccine, 2.0mg/ml TDS-IM injection HTNV DNA Vaccine, 2.0 mg/ml TDS-IM injection HTNV + PUUV Vaccine mixture, 1.0mg/mL + 1.0mg/ml TDS-IM injection

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-12-30
• Last updated: 2013-01-31

Locations

1 site across 1 country: United States