NCT03718130

Combination HTNV and PUUV DNA Vaccine

A Phase 1, Randomized Trial to Assess the Safety, Reactogenicity, and Immunogenicity of a Combination HTNV and PUUV DNA Vaccine Candidate Administered by Electroporation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults

Detailed description

The development of DNA (deoxyribonucleic acid) vaccines, such as those to be utilized in this study, is based on the observation that antigen-encoding DNA plasmids can induce both cellular and humoral immune responses against various viral and bacterial pathogens. DNA vaccines are perceived as having a number of potential advantages over other types of vaccines. For example, DNA vaccines are easily constructed by recombinant technology; easily and inexpensively manufactured as a well-characterized molecule \[DNA plasmid\]; and at boost, not eliminated by prior immune response to the carrier or vector. Furthermore, as nonliving vaccines, they cannot lead to infection. The object of DNA vaccination is to deliver DNA into the nuclei of cells capable of presenting the encoded antigen to immune reactive cells that can elicit an immune response. The study will enroll 6 randomized groups of 12 subjects each, for a total of 72 subjects. This approach will ensure at least 60 subjects complete all vaccinations at around 10 subjects per group, taking possible attrition into account. Subjects will receive one dose of vaccine on each of Days 0, 28, and 56 either intramuscularly or intradermally by electroporation and will be followed until Day 220.

Conditions

• Hantaan Virus Disease, Puumala Virus

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)	The HTNV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCT	Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)	The HTNV vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCT	Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)	The PUUV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCT	Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)	The PUUV DNA vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCT	Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)	The HTNV and PUUV vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
COMBINATION_PRODUCT	Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)	The HTNV and PUUV vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

Timeline

• Start date: 2019-07-10
• Primary completion: 2022-10-07
• Completion: 2022-10-07
• First posted: 2018-10-24
• Last updated: 2025-06-26
• Results posted: 2025-06-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study