Clinical Trial: Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary:
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.
Sponsor: U.S. Army Medical Research and Materiel Command
Current Primary Outcome:
- Change from baseline for solicited adverse events after each vaccination [ Time Frame: 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 [ Time Frame: 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
Original Primary Outcome: Same as current
Current Secondary Outcome: Change in neutralizing antibody levels from baseline to post vaccination [ Time Frame: Day 0, 28, 56, 84, 140, 180 and 240 ]
Original Secondary Outcome: Change in nuetralizing antibody levels from baseline to post vaccination [ Time Frame: Day 0, 28, 56, 84, 140, 180 and 240 ]
Information By: U.S. Army Medical Research and Materiel Command
Dates:
Date Received: December 23, 2011
Date Started: January 2012
Date Completion:
Last Updated: January 30, 2013
Last Verified: January 2013