NCT02776761

A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine

Hantaan Virus Plasmid DNA Vaccine (Expressing Gn and Gc Antigens; E. Coli) [HTNV Vaccine] and Puumala Virus Plasmid DNA Vaccine (Expressing Gn and Gc Antigens; E. Coli; Ajinomoto Bio-Pharma Services) [PUUV Vaccine] Administered Via Stratus Needle-free Injection System (PharmaJet, Inc.)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: U.S. Army Medical Research and Development Command · Federal
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

This is a single-center, randomized, single-blinded study of the Hantaan virus HTNV DNA vaccine alone, Puumala virus PUUV DNA vaccine alone, and mixed Hantaan/Puumala HTNV/PUUV DNA vaccines delivered intramuscularly IM by the needle-free PharmaJet Stratus DSJI device.

Detailed description

Investigational HTNV and PUUV DNA vaccines, manufactured in accordance with cGMP guidelines by Ajinomoto Bio-Pharma Services (California), from their respective drug substances, pWRG/HTN-M(co) and pWRG/PUU-M(s2),were constructed on a well-characterized plasmid backbone, pWRG7077. These plasmid DNA vaccines will be delivered IM using the needle-free, disposable syringe jet injection device (PharmaJet Stratis). Subjects will be randomized into 3 groups of 9 subjects each for a total of 27 subjects. Each subject will receive a total of 3 vaccinations. Group 1 vaccine will consist of 2 administrations of 1 mg of HTN plasmid (left and right deltoid) for a total of 2 mg/vaccination. Group 2 vaccine will consist of 2 administrations of 1 mg of PUU plasmid (left, right deltoid) for a total of 2 mg/vaccination. Group 3 vaccine will consist of a 1:1 mixture of HTNM and PUU vaccines (left, right deltoid) for a total of 2 mg/vaccination (1 mg/vaccination of each DNA). Vaccinations will be administered on Days 0, 28, and 56. There will be an optional 4th vaccination on Day 168 dependent on subject availability for the additional follow-up visit on Day 196, tolerability of the vaccinations to date, and investigator discretion. Volunteers will be invited back for the 4th vaccination to determine if a booster dose results in increased immunogenicity and seroconversion. All subjects will be followed until Day 252 (9 months). A Day 365 follow-up visit, for an immunogenicity draw only, may be requested dependent on immunogenicity results shortly after this final date, generally within 4 weeks of the Day 252 visit or once the assays can be completed. Subjects may be allowed to receive other licensed vaccinations or enroll in other clinical trials after the Day 252 visit.

Conditions

• Hantaan Virus

Interventions

Type	Name	Description
BIOLOGICAL	Hantaan Vaccine:	DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
BIOLOGICAL	Puumala Vaccine	DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
BIOLOGICAL	Hantaan/Puumala Vaccine	DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline

Timeline

• Start date: 2016-08-30
• Primary completion: 2017-09-27
• Completion: 2017-09-27
• First posted: 2016-05-18
• Last updated: 2021-02-16

Locations

1 site across 1 country: United States