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 ]

The endpoint used to measure immunogenicity of the HTNV and PUUV DNA vaccines is the production of neutralizing antibody titers to HTNV and PUUV (PRNT50 ≥ 1:20). Initial immunogenicity results will be analyzed on the basis of intention-to-treat, in which the outcomes of all subjects who had at least one dose of vaccine will be analyzed with the group to which they were originally assigned, regardless of whether they completed the study. Subsequently, all subjects who completed the 8-month study and have serologic data will be included in the analysis of immunogenicity.


Original Secondary Outcome: Change in nuetralizing antibody levels from baseline to post vaccination [ Time Frame: Day 0, 28, 56, 84, 140, 180 and 240 ]

The endpoint used to measure immunogenicity of the HTNV and PUUV DNA vaccines is the production of neutralizing antibody titers to HTNV and PUUV (PRNT50 ≥ 1:20). Initial immunogenicity results will be analyzed on the basis of intention-to-treat, in which the outcomes of all subjects who had at least one dose of vaccine will be analyzed with the group to which they were originally assigned, regardless of whether they completed the study. Subsequently, all subjects who completed the 8-month study and have serologic data will be included in the analysis of immunogenicity.


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