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Virus Therapy
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID) for Hantavirus Disease
Phase 1
Waitlist Available
Led By Kirsten E Lyke, 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 days 0, 28, 56, 84, 140 and 220
Awards & highlights
Study Summary
This trial looks at how safe and effective a vaccine is for hantaan and puumala viruses.
Eligible Conditions
- Hantavirus Disease, Puumala Virus Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 0, 28, 56, 84, 140 and 220
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 0, 28, 56, 84, 140 and 220
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Summary of Adverse Events (AEs) to Evaluate Safety and Reactogenicity of the HTNV, PUUV DNA and Combination HTNV/PUUV DNA Vaccines
Secondary outcome measures
Final Overall Rate of Seroconversion Over all Scheduled Time Points
Geometric Mean Titer (GMT) of the PsVNA50
Proportion of Seropositive Subjects
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Group I: Group 6: 6.0 mg HTNV/PUUV (3.0 mg each) - Intramuscular (IM)Experimental Treatment1 Intervention
0.5 mL 6.0 mg/mL HTNV DNA + 0.5 mL 6.0 mg/mL PUUV DNA (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group II: Group 5: 1.2 mg HTNV/PUUV (0.6 mg each) - Intradermal (ID)Experimental Treatment1 Intervention
0.1 mL 6.0 mg/mL HTNV DNA + 0.1 mL 6.0 mg/mL PUUV DNA (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group III: Group 4: 3.0 mg PUUV - Intramuscular (IM)Experimental Treatment1 Intervention
0.5 mL 6.0 mg/mL PUUV DNA + 0.5 mL 0.9% saline (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group IV: Group 3: 0.6 mg PUUV - Intradermal (ID)Experimental Treatment1 Intervention
0.1 mL 6.0 mg/mL PUUV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group V: Group 2: 3.0 mg HTNV - Intramuscular (IM)Experimental Treatment1 Intervention
0.5 mL 6.0 mg/mL HTNV DNA + 0.5 mL 0.9% saline (IM) The HTNV and PUUV DNA vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group VI: Group 1: 0.6 mg HTNV - Intradermal (ID)Experimental Treatment1 Intervention
0.1 mL 6.0 mg/mL HTNV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
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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
286 Previous Clinical Trials
245,687 Total Patients Enrolled
Kirsten E Lyke, MDPrincipal InvestigatorUniversity of Maryland
1 Previous Clinical Trials
60 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the criterion for participation in this medical study include individuals over 35 years old?
"In order to be deemed eligible for this experiment, participants must fall into the age range of 18 and 49. Other trials that cater to those younger than 18 or older than 65 have 48 studies or 84 respectively."
Answered by AI
Is it feasible for me to participate in this medical experiment?
"The entry requirements for this study necessitate that applicants have hantavirus infections and be aged between 18 to 49 years old. Approximately 72 individuals are necessary in order to meet the trial objectives."
Answered by AI
Are there any openings left for enrollment in this clinical trial?
"According to clinicaltrials.gov, this particular trial was initially posted on October 11th 2019 and last updated May 16th 2022. Unfortunately, it is not currently recruiting patients; however there are 119 other studies that have open enrollment periods right now."
Answered by AI
Have the FDA accredited HTNV/PUUV virus inoculations, administered by means of TriGrid Delivery System (TDS) Intradermal Delivery (ID), as safe and effective?
"Limited evidence for safety and efficacy means that Hantaan/Puumala (HTNV/PUUV) virus vaccines delivered through the TriGrid Delivery System (TDS) Intradermal Delivery (ID) received a score of 1."
Answered by AI
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