Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines (HTNV/PUUV Trial)
Palo Alto (17 mi)Overseen byJames E Moon, MD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Waitlist Available
Sponsor: U.S. Army Medical Research and Development Command
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is:
• To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device
Secondary:
• To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.
Eligibility Criteria
Treatment Details
3Treatment groups
Experimental Treatment
Group I: PUUV DNA VaccineExperimental Treatment1 Intervention
This group will receive Puumala Virus DNA Vaccine only
Group II: HTNV DNA VaccineExperimental Treatment1 Intervention
This group will receive Hantaan Virus DNA Vaccine only
Group III: HTNV + PUUVExperimental Treatment1 Intervention
This group will receive a 1:1 mixture of HTNV and PUUV DNA Vaccines
Find a clinic near you
Research locations nearbySelect from list below to view details:
Walter Reed Army Institute of ResearchSilver Spring, MD
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Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
US Army Medical Research Institute of Infectious DiseasesCollaborator
United States Army Medical Materiel Development ActivityCollaborator
Ichor Medical Systems IncorporatedIndustry Sponsor
Walter Reed Army Institute of Research (WRAIR)Collaborator