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Virus Therapy
Study to Evaluate the Safety, Tolerability, and Immunogenicity of Hantaan and Puumala Virus DNA Vaccines (HTNV/PUUV Trial)
Phase 1
Waitlist Available
Led By James E Moon, MD
Research Sponsored by U.S. Army Medical Research and Development Command
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Hemorrhagic Fever with Renal Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline for Unsolicited adverse events after each vaccination
Change from baseline for solicited adverse events after each vaccination
Secondary study objectives
Change in neutralizing antibody levels from baseline to post vaccination
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vaccine/device combination for prevention of HFRS
2012
Completed Phase 1
~40
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
U.S. Army Medical Research and Development CommandLead Sponsor
291 Previous Clinical Trials
246,147 Total Patients Enrolled
4 Trials studying Hemorrhagic Fever with Renal Syndrome
312 Patients Enrolled for Hemorrhagic Fever with Renal Syndrome
US Army Medical Research Institute of Infectious DiseasesFED
13 Previous Clinical Trials
1,357 Total Patients Enrolled
1 Trials studying Hemorrhagic Fever with Renal Syndrome
130 Patients Enrolled for Hemorrhagic Fever with Renal Syndrome
United States Army Medical Materiel Development ActivityFED
10 Previous Clinical Trials
19,401 Total Patients Enrolled
1 Trials studying Hemorrhagic Fever with Renal Syndrome
130 Patients Enrolled for Hemorrhagic Fever with Renal Syndrome
Ichor Medical Systems IncorporatedIndustry Sponsor
10 Previous Clinical Trials
408 Total Patients Enrolled
1 Trials studying Hemorrhagic Fever with Renal Syndrome
130 Patients Enrolled for Hemorrhagic Fever with Renal Syndrome
Walter Reed Army Institute of Research (WRAIR)FED
107 Previous Clinical Trials
36,743 Total Patients Enrolled
1 Trials studying Hemorrhagic Fever with Renal Syndrome
130 Patients Enrolled for Hemorrhagic Fever with Renal Syndrome
James E Moon, MDPrincipal InvestigatorWRAIR, Clinical Trials Center
1 Previous Clinical Trials
12 Total Patients Enrolled