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 (HTNV/PUUV)

NCT01502345 Phase 1 COMPLETED

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.

Details

Lead sponsor	U.S. Army Medical Research and Development Command
Phase	Phase 1
Status	COMPLETED
Enrolment	31
Start date	2012-01
Completion	2013-01

Conditions

• Hemorrhagic Fever With Renal Syndrome

Interventions

• Vaccine/device combination for prevention of HFRS

Primary outcomes

• Change from baseline for solicited adverse events after each vaccination — Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
  • The nature, frequency, and severity of local and systemic AEs or SAEs associated with TDS-IM-EP-based administration of HTNV and PUUV vaccines
• Change from baseline for Unsolicited adverse events after each vaccination — Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
  • The nature, frequency, and severity of local and systemic AEs or SAEs associated with TDS-IM-EP-based administration of HTNV and PUUV vaccines

Countries

United States