A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine
Condition: Hantaan Virus
MeSH terms: Virus Diseases
Study type: Interventional
Phase: Phase 1

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.
    

Intervention name(s): Hantaan Vaccine:; Puumala Vaccine; Hantaan/Puumala Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline; DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline; DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study will enroll 3 randomized groups of 9 subjects for a total of 27 subjects. Every subject will receive a total of 3 vaccinations. Subjects will be blinded to the group they are randomized to. Each vaccination consists of 2 administrations of 1 mg (left/right deltoid) for a total of 2 mg/vaccination. Group 1 will be vaccinated with the HTNV vaccine, pWRG/HTN-M (co). Group 2 will be vaccinated with the PUUV vaccine, pWRG/PUU-M (s2). Group 3 will be vaccinated with a combined HTNV/PUUV vaccines. Each group will be vaccinated on Days 0, 28, and 56. An optional 4th vaccination on Day 168 with follow-up on Day 196. All doses will be administered with PharmaJet Stratis device. All subjects to be followed until at least 3 months post last vaccination with Day 252 the final study visit (a 12-month, optional follow-up visit may be requested approximately on Day 365). Subjects will complete postinjection memory aids for 7 days after each vaccination.
Masking: Single (Participant)
Primary purpose: Prevention