Combination HTNV and PUUV DNA Vaccine | NCT03718130 | Trialant
NCT03718130
Sponsor
U.S. Army Medical Research and Development Command
Status
Completed
Last Update Posted
Jun 26, 2025Actual
Enrollment
61Actual
Phase
Phase 1
Conditions
Hantaan Virus Disease, Puumala Virus
Interventions
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT03718130
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
S-15-39
Secondary IDs
Not provided
Brief Title
Combination HTNV and PUUV DNA Vaccine
Official Title
A Phase 1, Randomized Trial to Assess the Safety, Reactogenicity, and Immunogenicity of a Combination HTNV and PUUV DNA Vaccine Candidate Administered by Electroporation
Acronym
Not provided
Organization
U.S. Army Medical Research and Development CommandFED
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 10, 2019Actual
Primary Completion Date
Oct 7, 2022Actual
Completion Date
Oct 7, 2022Actual
First Submitted Date
Oct 18, 2018
First Submission Date that Met QC Criteria
Oct 22, 2018
First Posted Date
Oct 24, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Nov 21, 2023
Results First Submitted that Met QC Criteria
Jun 9, 2025
Results First Posted Date
Jun 26, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 9, 2025
Last Update Posted Date
Jun 26, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
U.S. Army Medical Research and Development CommandFED
Collaborators
Name
Class
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
The Geneva Foundation
OTHER
US Army Medical Research Institute of Infectious Diseases
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
No
FDAAA801 Violation
Not provided
Description Module
Brief Summary
To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults
Detailed Description
The development of DNA (deoxyribonucleic acid) vaccines, such as those to be utilized in this study, is based on the observation that antigen-encoding DNA plasmids can induce both cellular and humoral immune responses against various viral and bacterial pathogens. DNA vaccines are perceived as having a number of potential advantages over other types of vaccines. For example, DNA vaccines are easily constructed by recombinant technology; easily and inexpensively manufactured as a well-characterized molecule [DNA plasmid]; and at boost, not eliminated by prior immune response to the carrier or vector. Furthermore, as nonliving vaccines, they cannot lead to infection. The object of DNA vaccination is to deliver DNA into the nuclei of cells capable of presenting the encoded antigen to immune reactive cells that can elicit an immune response.
The study will enroll 6 randomized groups of 12 subjects each, for a total of 72 subjects. This approach will ensure at least 60 subjects complete all vaccinations at around 10 subjects per group, taking possible attrition into account. Subjects will receive one dose of vaccine on each of Days 0, 28, and 56 either intramuscularly or intradermally by electroporation and will be followed until Day 220.
Conditions Module
Conditions
Hantaan Virus Disease, Puumala Virus
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
61Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group 1: 0.6 mg HTNV - Intradermal (ID)
Experimental
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Group 2: 3.0 mg HTNV - Intramuscular (IM)
Experimental
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Group 3: 0.6 mg PUUV - Intradermal (ID)
Experimental
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Group 4: 3.0 mg PUUV - Intramuscular (IM)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Combination Product
The HTNV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Summary of Solicited Local Adverse Events (AEs)
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Days 0-14 after injection
Summary of Solicited Systemic Adverse Events (AEs)
Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection
Days 0-28 after injection
Proportion of Seropositive Subjects
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
Have provided written informed consent before screening
Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination
Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.
Available and able to participate for all study visits and procedures
Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination.
A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed > 1 year prior to screening. They must agree not to father a child until 6 months after the last vaccination. These subjects must agree to use a barrier method of birth control (eg, either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository).
Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or < 1 year of the last menses if perimenopausal. For this study, an effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly (see the Manual of Procedures [MOP] for a list of acceptable methods).
Female subjects agree to not donate eggs (ova, oocytes), and male subjects agree to not donate sperm from the start of screening until at least 6 months after the last vaccination.
Negative hantavirus PsVNA test result at screening
Exclusion Criteria:
History of prior infection with any hantavirus virus or prior participation in an HTNV, PUUV, or Andes virus vaccine trial.
Has plans to travel to an area with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission during the study.
NOTE: Refer to the MOP for information on areas with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission
History of severe local or systemic reactions to any vaccine or vaccine products or a history of severe allergic reactions.
This includes a known allergy to an aminoglycoside (eg, gentamicin, tobramycin, neomycin, and streptomycin).
Is currently participating in or plans to participate in another study involving any investigational product (eg, vaccine, drug, or biologics) or a study that involves blood drawing, and/or an invasive procedure.
An invasive procedure includes endoscopy, bronchoscopy, or procedure requiring administration of IV contrast or removal of tissue.
Receipt or planned receipt of any live vaccination, experimental or otherwise, within the period 30 days prior to or after each vaccination and receipt or planned receipt of an inactivated vaccination, experimental or otherwise, within the period of 14 days prior to or after each vaccination.
Individuals, who based on clinical assessment by the investigator, have insufficient muscle mass to accommodate the 1 inch/25 mm penetration depth or have a skinfold thickness at eligible injection sites (deltoid region) that exceeds 40 mm.
Individuals in whom the ability to observe local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
Presence of any surgical or traumatic metal implants at the injection site (medial deltoid muscles or overlying skin).
Screening laboratory results that are outside of the normal range (exceptions listed below) within 56 days prior to enrollment
Hemoglobin > 11.0 g/dL for women; > 12.9 g/dL for men
CBC (WBC and platelet) with differential either within institutional normal range or Grade 1 deviation from normal and deemed clinically insignificant
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.25x upper limit of normal (ULN)
Serum creatinine ≤ ULN
Subjects with autoimmune disorders or chronic inflammatory disorders with a potential autoimmune correlation.
Receipt of immunoglobulins and/or any blood products within the 120 days preceding screening or planned administration during the study period
Donation of blood to a blood bank within 56 days prior to screening and at any time during the study period.
Subject seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (anti-HCV).
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, or use of anticancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to screening.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
49 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Kirsten E Lyke, MD
University of Maryland
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
University of Maryland
Baltimore
Maryland
21201
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 2, 2022
Aug 9, 2023
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Ichor Medical Systems Incorporated
INDUSTRY
Randomized
Intervention Model
Single Group Assignment
Intervention Model Description
6 groups of 12 subjects each will receive varying vaccine dosages and vaccine candidate combinations
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Combination Product: Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)
Group 1: 0.6 mg HTNV - Intradermal (ID)
HTNV vaccine using TDS ID
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Combination Product
The HTNV vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 2: 3.0 mg HTNV - Intramuscular (IM)
HTNV vaccine using TDS IM
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Combination Product
The PUUV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 3: 0.6 mg PUUV - Intradermal (ID)
PUUV vaccine using TDS ID
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Combination Product
The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 4: 3.0 mg PUUV - Intramuscular (IM)
PUUV vaccine using the TDS IM
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Combination Product
The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)
Combination Product
The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point
Days 0, 28, 56, 84, 140 and 220
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Determination of the final overall rate of serconversion over all scheduled time points to study completion for each study group. Seroconversion is defined as a post-vaccination HTNV- or PUUV-specific titer of ≥1:40, or a minimum four-fold rise compared to baseline titer, and all study volunteers will begin the study with a baseline titer <20 (ie, seronegative)
Days 0, 28, 56, 84, 140 and 220
Geometric Mean Titer (GMT) of the PsVNA50
GMT of the PsVNA50 for HTNV- and PUUV-specific neutralizing antibodies at each schedule time point for each study group and over all time points for each study group
Days 0, 28, 56, 84, 140 and 220
FG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
FG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
FG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
FG00011 subjects
FG00112 subjects
FG00212 subjects
FG00312 subjects
FG0042 subjects
FG00512 subjects
COMPLETED
FG0000 subjects
FG00111 subjects
FG0020 subjects
FG00312 subjects
FG0040 subjects
FG00512 subjects
NOT COMPLETED
FG00011 subjects
FG0011 subjects
FG00212 subjects
FG0030 subjects
FG0042 subjects
FG0050 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
BG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
BG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
BG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00011
BG00112
BG00212
BG00312
BG0042
BG00512
BG00661
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Full Range
years
Title
Denominators
Categories
Title
Measurements
BG00027.2(22 to 41)
BG00133.3(25 to 46)
BG00229.8(22 to 43)
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0009
BG0018
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
African American
BG0003
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Summary of Solicited Local Adverse Events (AEs)
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Summary of solicited local AE for Groups 1 through Group 6
Posted
Count of Participants
Participants
Days 0-14 after injection
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
OG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG003
Title
Denominators
Categories
Dose 1 : Ecchymosis
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Primary
Summary of Solicited Systemic Adverse Events (AEs)
Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Summary of solicited systemic AE by Group and Dose Number, for Groups 1 through Group 6
Posted
Count of Participants
Participants
Days 0-14 after injection
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection
Unsolicited Events that occurred across groups (Group 1 through Group 6) from the time of the first injection through 28 days following each injection
Posted
Count of Participants
Participants
Days 0-28 after injection
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
Secondary
Proportion of Seropositive Subjects
Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point
The planned enrolled sample size was 82 participants. A total of 61 participants were enrolled in the study. The reduction in total enrolled participants occurred due to the SARS-CoV-2 pandemic and study halt for ad Hoc Safety Monitoring Committee (SMC) review of an SAE required by the sponsor.
Posted
Number
95% Confidence Interval
proportion of participants
Days 0, 28, 56, 84, 140 and 220
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
Secondary
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Determination of the final overall rate of serconversion over all scheduled time points to study completion for each study group. Seroconversion is defined as a post-vaccination HTNV- or PUUV-specific titer of ≥1:40, or a minimum four-fold rise compared to baseline titer, and all study volunteers will begin the study with a baseline titer <20 (ie, seronegative)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day
Posted
Number
95% Confidence Interval
proportion of participants
Days 0, 28, 56, 84, 140 and 220
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
Secondary
Geometric Mean Titer (GMT) of the PsVNA50
GMT of the PsVNA50 for HTNV- and PUUV-specific neutralizing antibodies at each schedule time point for each study group and over all time points for each study group
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day
Posted
Geometric Mean
95% Confidence Interval
titers
Days 0, 28, 56, 84, 140 and 220
ID
Title
Description
OG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ 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.
OG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
Time Frame
6 months from last vaccination (Day 220)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Group 1: 0.6 mg HTNV - Intradermal (ID)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
0
11
0
11
10
11
EG001
Group 2: 3.0 mg HTNV - Intramuscular (IM)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
0
12
0
12
11
12
EG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
0
12
1
12
7
12
EG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
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 TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
0
12
0
12
9
12
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
ALT Elevation
Investigations
MedDRA 26.1
Systematic Assessment
Alanine Aminotransferase Increased
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG0030 events0 affected12 at risk
Seizure
Nervous system disorders
MedDRA 26.1
Systematic Assessment
Generalized Tonic Clonic Seizure
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Alcohol Withdrawal Seizure
Nervous system disorders
MedDRA 26.1
Systematic Assessment
Alcoholic Seizure
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0021 events1 affected12 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Local AE
EG00011 events3 affected11 at risk
EG00112 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG00312 events3 affected12 at risk
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Local AE
EG00011 events5 affected11 at risk
EG00112 events1 affected12 at risk
EG00212 events6 affected12 at risk
EG003
Induration (Hardness)/Swelling
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Local AE
EG00011 events4 affected11 at risk
EG00112 events1 affected12 at risk
EG00212 events3 affected12 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Local AE
EG00011 events2 affected11 at risk
EG00112 events9 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Tenderness
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Local AE
EG00011 events7 affected11 at risk
EG00112 events8 affected12 at risk
EG00212 events5 affected12 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Local AE
EG0008 events1 affected8 at risk
EG00111 events3 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Local AE
EG0008 events3 affected8 at risk
EG00111 events1 affected11 at risk
EG0028 events2 affected8 at risk
EG003
Induration (Hardness)/Swelling
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Local AE
EG0008 events2 affected8 at risk
EG00111 events1 affected11 at risk
EG0028 events2 affected8 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Local AE
EG0008 events1 affected8 at risk
EG00111 events5 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Tenderness
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Local AE
EG0008 events3 affected8 at risk
EG00111 events6 affected11 at risk
EG0028 events1 affected8 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Local AE
EG0004 events1 affected4 at risk
EG00111 events2 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Local AE
EG0004 events2 affected4 at risk
EG0010 events0 affected11 at risk
EG0024 events2 affected4 at risk
EG003
Induration (Hardness)/Swelling
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Local AE
EG0004 events2 affected4 at risk
EG0010 events0 affected11 at risk
EG0024 events1 affected4 at risk
EG003
Pain
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Local AE
EG0004 events1 affected4 at risk
EG00111 events3 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Tenderness
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Local AE
EG0004 events2 affected4 at risk
EG00111 events7 affected11 at risk
EG0024 events3 affected4 at risk
EG003
Axillary pain or discomfort
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG00011 events3 affected11 at risk
EG00112 events2 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG00011 events4 affected11 at risk
EG00112 events4 affected12 at risk
EG00212 events4 affected12 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG00011 events4 affected11 at risk
EG00112 events2 affected12 at risk
EG00212 events2 affected12 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG00011 events1 affected11 at risk
EG00112 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Myalgia (Body aches/Muscular pain)
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG00011 events1 affected11 at risk
EG00112 events6 affected12 at risk
EG00212 events1 affected12 at risk
EG003
Tachypnea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG0000 events0 affected11 at risk
EG0010 events0 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Temperature (fever)
General disorders
MedDRA 26.1
Systematic Assessment
Dose 1, Solicited Systemic AE
EG0000 events0 affected11 at risk
EG00112 events1 affected12 at risk
EG0020 events0 affected12 at risk
EG003
Axillary pain or discomfort
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0008 events2 affected8 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0008 events3 affected8 at risk
EG00111 events3 affected11 at risk
EG0028 events1 affected8 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0008 events4 affected8 at risk
EG00111 events2 affected11 at risk
EG0028 events1 affected8 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0000 events0 affected8 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Myalgia (Body aches/Muscular pain)
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0000 events0 affected8 at risk
EG00111 events4 affected12 at risk
EG0020 events0 affected8 at risk
EG003
Tachypnea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0000 events0 affected8 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Temperature (fever)
General disorders
MedDRA 26.1
Systematic Assessment
Dose 2, Solicited Systemic AE
EG0000 events0 affected8 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected8 at risk
EG003
Axillary pain or discomfort
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0004 events1 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Fatigue
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0004 events1 affected4 at risk
EG00111 events1 affected11 at risk
EG0024 events3 affected4 at risk
EG003
Headache
Nervous system disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0004 events1 affected4 at risk
EG00111 events3 affected11 at risk
EG0024 events2 affected4 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Myalgia (Body aches/Muscular pain)
Musculoskeletal and connective tissue disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0000 events0 affected4 at risk
EG00111 events3 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Tachypnea
Respiratory, thoracic and mediastinal disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Temperature
General disorders
MedDRA 26.1
Systematic Assessment
Dose 3, Solicited Systemic AE
EG0000 events0 affected4 at risk
EG0010 events0 affected11 at risk
EG0020 events0 affected4 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Elissa K. Thomas, Associate Director, Corporate Strategy
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00312
OG0042
OG00512
Title
Denominators
Categories
Dose 1: Axillary Pain or Discomfort
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG0042
ParticipantsOG00512
Title
Measurements
None
OG0008
OG00110
OG00212
OG003
Dose 1: Fatigue
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 1: Headache
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 1: Lymphadenopathy
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 1: Myalgia (Body aches/Muscular Pain)
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 1: Tachypnea
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 1: Temperature
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
Dose 2: Axillary Pain or Discomfort
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Fatigue
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Headache
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Lymphadenopathy
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Myalgia (Body aches/Muscular pain)
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Tachypnea
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 2: Temperature (fever)
ParticipantsOG0008
ParticipantsOG00111
ParticipantsOG0028
ParticipantsOG00312
Dose 3: Axillary pain or discomfort
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Fatigue
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Headache
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Lymphadenopathy
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Myalgia (Body aches/Muscular pain)
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Tachypnea
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
Dose 3: Temperature (fever)
ParticipantsOG0004
ParticipantsOG00111
ParticipantsOG0024
ParticipantsOG00312
OG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
OG006
All Groups
Total Participants from Group 1 through 6
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00312
OG0042
OG00512
OG00661
Title
Denominators
Categories
Pruritus
Title
Measurements
OG0004
OG0010
OG0022
OG0030
OG0040
OG0050
OG0066
Sore Throat
Title
Measurements
OG0000
OG0011
OG0020
OG003
COVID-19
Title
Measurements
OG0001
OG0010
OG0020
OG003
Lightheadedness
Title
Measurements
OG0000
OG0011
OG0020
OG003
Muscle pain or spasms
Title
Measurements
OG0001
OG0010
OG0021
OG003
Viral illness/colds
Title
Measurements
OG0000
OG0011
OG0021
OG003
Back Pain
Title
Measurements
OG0001
OG0010
OG0020
OG003
Bacterial vaginitis
Title
Measurements
OG0001
OG0010
OG0020
OG003
Increased respiration
Title
Measurements
OG0000
OG0011
OG0020
OG003
Vomiting
Title
Measurements
OG0000
OG0011
OG0020
OG003
Ulcerative colitis
Title
Measurements
OG0000
OG0011
OG0020
OG003
Lump in armpit
Title
Measurements
OG0000
OG0011
OG0020
OG003
Constipation
Title
Measurements
OG0000
OG0011
OG0020
OG003
AST elevation (Grade 3)
Title
Measurements
OG0000
OG0010
OG0021
OG003
ALT elevation
Title
Measurements
OG0000
OG0010
OG0021
OG003
Seizure
Title
Measurements
OG0000
OG0010
OG0021
OG003
Scabbing
Title
Measurements
OG0000
OG0010
OG0021
OG003
Pus
Title
Measurements
OG0000
OG0010
OG0021
OG003
Influenza
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nausea
Title
Measurements
OG0000
OG0010
OG0020
OG003
Fever
Title
Measurements
OG0000
OG0010
OG0020
OG003
Painful urination
Title
Measurements
OG0000
OG0010
OG0020
OG003
Nerve pain in limb
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00312
OG0042
OG00512
Title
Denominators
Categories
Day 0
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG0042
ParticipantsOG00512
Title
Measurements
OG0000(0 to 0.28)
OG0010(0 to 0.26)
OG0020(0 to 0.26)
OG003
Day 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG00312
Day 56
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG00312
Day 84
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0024
ParticipantsOG00312
Day 140
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG00312
Day 220
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG0020
ParticipantsOG00312
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 TriGridâ„¢ 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine will be administered using the IM TriGridâ„¢ 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.
OG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00312
OG0042
OG00512
Title
Denominators
Categories
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG0030
ParticipantsOG0040
ParticipantsOG0050
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG003
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG003
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0024
ParticipantsOG003
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 220
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG0020
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 0
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0024
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG0020
ParticipantsOG003
OG002
Group 3: 0.6 mg PUUV - Intradermal (ID)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGridâ„¢ 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.
OG003
Group 4: 3.0 mg PUUV - Intramuscular (IM)
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 TriGridâ„¢ 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine will be administered using the IM TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV and PUUV vaccines will be administered using the ID TriGridâ„¢ 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.
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 TriGridâ„¢ 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM): The HTNV and PUUV vaccines will be administered using the IM TriGridâ„¢ 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.
Units
Counts
Participants
OG00011
OG00112
OG00212
OG00312
OG0042
OG00512
Title
Denominators
Categories
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG00312
ParticipantsOG0042
ParticipantsOG00512
Title
Measurements
OG00014.1(14.1 to 14.1)
OG00114.1(14.1 to 14.1)
OG00214.1(14.1 to 14.1)
OG003
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG003
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG003
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0024
ParticipantsOG003
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220
ParticipantsOG0000
ParticipantsOG00111
ParticipantsOG0020
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00212
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28
ParticipantsOG0008
ParticipantsOG00112
ParticipantsOG0028
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56
ParticipantsOG0003
ParticipantsOG00112
ParticipantsOG0025
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG0024
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140
ParticipantsOG00011
ParticipantsOG00112
ParticipantsOG00211
ParticipantsOG003
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220