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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
27
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
WRAIR Clinical Trials Center
Silver Spring, Maryland, United States
Hantaan Vaccine: Number of Adverse Events
Number of adverse events.
Time frame: 365 days
Puumala Vaccine: Number of Adverse Events
Number of adverse events.
Time frame: 365 days
Hantaan/Puumala Vaccine: Number of Adverse Events
Number of adverse events.
Time frame: 365 days
Hantaan Vaccine (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Time frame: 365 days
Puumala Vaccine (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Time frame: 365 days
Hantaan/Puumala Vaccin (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Time frame: 365 days
Hantaan Vaccine (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Time frame: 365 days
Puumala Vaccine (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Time frame: 365 days
Hantaan/Puumala Vaccin (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Time frame: 365 days
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Hantaan Vaccine (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Time frame: 84 days
Puumala Vaccine (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Time frame: 84 days
Hantaan/Puumala Vaccin (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Time frame: 84 days