Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02776761
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2016-05-13
Brief Title:
A Single-blind Study to Evaluate the Safety Tolerability and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine
Sponsor:
US Army Medical Research and Development Command
Organization:
US Army Medical Research and Development Command
Study Overview
Official Title:
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
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 HantaanPuumala HTNVPUUV 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 pWRGHTN-Mco and pWRGPUU-Ms2were 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 mgvaccination Group 2 vaccine will consist of 2 administrations of 1 mg of PUU plasmid left right deltoid for a total of 2 mgvaccination Group 3 vaccine will consist of a 11 mixture of HTNM and PUU vaccines left right deltoid for a total of 2 mgvaccination 1 mgvaccination 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| WRAIR 2289 | OTHER | WRAIR | None |