NCT04333459

Safety and Immunogenicity of a Hantaan Virus DNA Vaccine and a Puumala Virus DNA Vaccine, For The Prevention of Hemorrhagic Fever With Renal Syndrome

A Phase 2A, Randomized, Double-Blind Study To Evaluate The Safety And Immunogenicity Of A Hantaan Virus DNA Vaccine And A Puumala Virus DNA Vaccine, For The Prevention Of Hemorrhagic Fever With Renal Syndrome, Administered To Healthy Adult Volunteers Using The Pharmajet Stratis® Needle-Free Jet Injection Delivery Device

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine.

Detailed description

The study will enroll 4 randomized groups of 33 subjects each for a total of 132 subjects. Every subject will receive a total of 4 vaccinations. Subjects and study personnel will be blinded to the group that they are randomized to (double-blind). The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine). For the 2 mg dose, each vaccination consists of 2 administrations of 1 mg (left and right deltoid) for a total of 2 mg/vaccination. For the 1 mg dose, each vaccination consists of 2 administrations of 0.5 mg (left and right deltoid) for a total of 1 mg/vaccination. Group 1 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 2 mg/vaccination dose. Group 2 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 1 mg/vaccination dose. Group 3 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 2 mg/vaccination dose. Group 4 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 1 mg/vaccination dose. Each group will be vaccinated on Days 1, 29, 57 and 169. All doses will be administered with the PharmaJet Stratis device, which is FDA cleared for IM administration of vaccines. All subjects will be followed until 1 month after the last vaccination with Day 197 being the final study visit. Subjects will complete post-injection memory aids for 7 days after each vaccination.

Conditions

• Hantaan Virus Nephropathy
• Puumala Virus Nephropathy

Interventions

Type	Name	Description
BIOLOGICAL	Hataan DNA Vaccine/Puumala DNA Vaccine	Vaccine compared in High and Lose Doses.

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-12-31
• Completion: 2023-12-31
• First posted: 2020-04-03
• Last updated: 2022-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study