Trial Outcomes & Findings for Combination HTNV and PUUV DNA Vaccine (NCT NCT03718130)
NCT ID: NCT03718130
Last Updated: 2025-06-26
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
61 participants
Primary outcome timeframe
Days 0-14 after injection
Results posted on
2025-06-26
Participant Flow
Participant milestones
| Measure |
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 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine 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 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 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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine 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 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 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine 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 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 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
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.
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 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
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.
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 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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
12
|
12
|
2
|
12
|
|
Overall Study
COMPLETED
|
0
|
11
|
0
|
12
|
0
|
12
|
|
Overall Study
NOT COMPLETED
|
11
|
1
|
12
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination HTNV and PUUV DNA Vaccine
Baseline characteristics by cohort
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The HTNV vaccine 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 2: 3.0 mg HTNV - Intramuscular (IM)
n=12 Participants
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.
Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The HTNV vaccine 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 3: 0.6 mg PUUV - Intradermal (ID)
n=12 Participants
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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine 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 4: 3.0 mg PUUV - Intramuscular (IM)
n=12 Participants
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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM): The PUUV DNA vaccine 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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.
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 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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.
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 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.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
27.2 years
n=5 Participants
|
33.3 years
n=7 Participants
|
29.8 years
n=5 Participants
|
37.2 years
n=4 Participants
|
31.5 years
n=21 Participants
|
28.6 years
n=8 Participants
|
31.3 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
44 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
54 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
African American
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Others
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Days 0-14 after injectionPopulation: Summary of solicited local AE for Groups 1 through Group 6
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
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Pain · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Erythema · Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Induration (Hardness)/Swelling · None
|
2 Participants
|
11 Participants
|
3 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Induration (Hardness)/Swelling · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Induration (Hardness)/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Induration (Hardness)/Swelling · Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Pain · None
|
3 Participants
|
8 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Pain · Mild
|
0 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Tenderness · None
|
2 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Tenderness · Mild
|
1 Participants
|
6 Participants
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Tenderness · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Ecchymosis · None
|
8 Participants
|
11 Participants
|
12 Participants
|
9 Participants
|
2 Participants
|
9 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Ecchymosis · Mild
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Ecchymosis · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Ecchymosis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Erythema · None
|
6 Participants
|
11 Participants
|
6 Participants
|
12 Participants
|
1 Participants
|
9 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Erythema · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Erythema · Moderate
|
2 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Erythema · Severe
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Induration (Hardness)/Swelling · None
|
7 Participants
|
11 Participants
|
9 Participants
|
10 Participants
|
1 Participants
|
9 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Induration (Hardness)/Swelling · Mild
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Induration (Hardness)/Swelling · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Induration (Hardness)/Swelling · Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Pain · None
|
9 Participants
|
3 Participants
|
12 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Pain · Mild
|
2 Participants
|
8 Participants
|
0 Participants
|
8 Participants
|
0 Participants
|
6 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Pain · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Tenderness · None
|
4 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Tenderness · Mild
|
6 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
1 Participants
|
5 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Tenderness · Moderate
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 1 : Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Ecchymosis · None
|
7 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
6 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Ecchymosis · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Ecchymosis · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Ecchymosis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Erythema · None
|
5 Participants
|
10 Participants
|
6 Participants
|
9 Participants
|
2 Participants
|
6 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Erythema · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Erythema · Moderate
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Erythema · Severe
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Induration (Hardness)/Swelling · None
|
6 Participants
|
10 Participants
|
6 Participants
|
12 Participants
|
2 Participants
|
6 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Induration (Hardness)/Swelling · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Induration (Hardness)/Swelling · Moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Induration (Hardness)/Swelling · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Pain · None
|
7 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Pain · Mild
|
0 Participants
|
5 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Pain · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Tenderness · None
|
5 Participants
|
5 Participants
|
7 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Tenderness · Mild
|
2 Participants
|
4 Participants
|
1 Participants
|
7 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Tenderness · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 2 : Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Ecchymosis · None
|
3 Participants
|
9 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Ecchymosis · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Ecchymosis · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Ecchymosis · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Erythema · None
|
2 Participants
|
11 Participants
|
2 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Erythema · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Local Adverse Events (AEs)
Dose 3 : Erythema · Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Days 0-14 after injectionPopulation: Summary of solicited systemic AE by Group and Dose Number, for Groups 1 through Group 6
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
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Axillary Pain or Discomfort · None
|
8 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
2 Participants
|
10 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Axillary Pain or Discomfort · Mild
|
3 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Axillary Pain or Discomfort · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Axillary Pain or Discomfort · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Fatigue · None
|
7 Participants
|
8 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Fatigue · Mild
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Fatigue · Moderate
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Fatigue · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Headache · None
|
7 Participants
|
10 Participants
|
10 Participants
|
10 Participants
|
2 Participants
|
9 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Headache · Mild
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Headache · Moderate
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Lymphadenopathy · None
|
10 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
2 Participants
|
12 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Lymphadenopathy · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Lymphadenopathy · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Lymphadenopathy · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Myalgia (Body aches/Muscular Pain) · None
|
10 Participants
|
6 Participants
|
11 Participants
|
9 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Myalgia (Body aches/Muscular Pain) · Mild
|
1 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Myalgia (Body aches/Muscular Pain) · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Myalgia (Body aches/Muscular Pain) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Tachypnea · None
|
11 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
2 Participants
|
12 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Tachypnea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Tachypnea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Tachypnea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Temperature · None
|
11 Participants
|
11 Participants
|
12 Participants
|
11 Participants
|
2 Participants
|
12 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Temperature · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 1: Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Axillary Pain or Discomfort · None
|
6 Participants
|
11 Participants
|
8 Participants
|
10 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Axillary Pain or Discomfort · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Axillary Pain or Discomfort · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Axillary Pain or Discomfort · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Fatigue · None
|
5 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
2 Participants
|
6 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Fatigue · Mild
|
2 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Fatigue · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Headache · None
|
4 Participants
|
9 Participants
|
7 Participants
|
11 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Headache · Mild
|
4 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Headache · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Lymphadenopathy · None
|
8 Participants
|
11 Participants
|
8 Participants
|
12 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Lymphadenopathy · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Lymphadenopathy · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Lymphadenopathy · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Myalgia (Body aches/Muscular pain) · None
|
8 Participants
|
7 Participants
|
8 Participants
|
9 Participants
|
2 Participants
|
5 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Myalgia (Body aches/Muscular pain) · Mild
|
0 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Myalgia (Body aches/Muscular pain) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Myalgia (Body aches/Muscular pain) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Tachypnea · None
|
8 Participants
|
11 Participants
|
8 Participants
|
12 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Tachypnea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Tachypnea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Tachypnea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Temperature (fever) · None
|
8 Participants
|
11 Participants
|
8 Participants
|
12 Participants
|
2 Participants
|
7 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Temperature (fever) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Temperature (fever) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 2: Temperature (fever) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Axillary pain or discomfort · None
|
3 Participants
|
11 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Axillary pain or discomfort · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Axillary pain or discomfort · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Axillary pain or discomfort · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Fatigue · None
|
3 Participants
|
10 Participants
|
1 Participants
|
11 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Fatigue · Mild
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Fatigue · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Headache · None
|
3 Participants
|
8 Participants
|
2 Participants
|
12 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Headache · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Headache · Moderate
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Lymphadenopathy · None
|
4 Participants
|
11 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Lymphadenopathy · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Lymphadenopathy · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Lymphadenopathy · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Myalgia (Body aches/Muscular pain) · None
|
4 Participants
|
8 Participants
|
4 Participants
|
11 Participants
|
2 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Myalgia (Body aches/Muscular pain) · Mild
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Myalgia (Body aches/Muscular pain) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Myalgia (Body aches/Muscular pain) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Tachypnea · None
|
4 Participants
|
11 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Tachypnea · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Tachypnea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Tachypnea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Temperature (fever) · None
|
4 Participants
|
11 Participants
|
4 Participants
|
12 Participants
|
2 Participants
|
2 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Temperature (fever) · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Temperature (fever) · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Summary of Solicited Systemic Adverse Events (AEs)
Dose 3: Temperature (fever) · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Days 0-28 after injectionPopulation: Unsolicited Events that occurred across groups (Group 1 through Group 6) from the time of the first injection through 28 days following each injection
Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
n=61 Participants
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Bacterial vaginitis
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Increased respiration
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Vomiting
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Pruritus
|
4 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
6 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Sore Throat
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
COVID-19
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Lightheadedness
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Muscle pain or spasms
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Viral illness/colds
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Back Pain
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Ulcerative colitis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Lump in armpit
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Constipation
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
AST elevation (Grade 3)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
ALT elevation
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Seizure
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Scabbing
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Pus
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Influenza
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Nausea
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Fever
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Painful urination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Nerve pain in limb
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Days 0, 28, 56, 84, 140 and 220Population: 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.
Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Proportion of Seropositive Subjects
Day 140
|
0.73 proportion of participants
Interval 0.39 to 0.94
|
0.5 proportion of participants
Interval 0.21 to 0.79
|
0.09 proportion of participants
Interval 0.0 to 0.41
|
0.17 proportion of participants
Interval 0.02 to 0.48
|
0 proportion of participants
Interval 0.0 to 0.84
|
—
|
—
|
|
Proportion of Seropositive Subjects
Day 0
|
0 proportion of participants
Interval 0.0 to 0.28
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.84
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
—
|
|
Proportion of Seropositive Subjects
Day 28
|
0.63 proportion of participants
Interval 0.24 to 0.91
|
0.42 proportion of participants
Interval 0.15 to 0.72
|
0.13 proportion of participants
Interval 0.0 to 0.53
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0 proportion of participants
Interval 0.0 to 0.84
|
0.14 proportion of participants
Interval 0.0 to 0.58
|
—
|
|
Proportion of Seropositive Subjects
Day 56
|
0.67 proportion of participants
Interval 0.09 to 0.99
|
0.58 proportion of participants
Interval 0.28 to 0.85
|
0.4 proportion of participants
Interval 0.05 to 0.85
|
0.33 proportion of participants
Interval 0.1 to 0.65
|
0 proportion of participants
Interval 0.0 to 0.84
|
0.5 proportion of participants
Interval 0.01 to 0.99
|
—
|
|
Proportion of Seropositive Subjects
Day 84
|
1 proportion of participants
Interval 0.4 to 1.0
|
0.75 proportion of participants
Interval 0.43 to 0.95
|
0.75 proportion of participants
Interval 0.19 to 0.99
|
0.33 proportion of participants
Interval 0.1 to 0.65
|
0 proportion of participants
Interval 0.0 to 0.84
|
0.5 proportion of participants
Interval 0.01 to 0.99
|
—
|
|
Proportion of Seropositive Subjects
Day 220
|
—
|
0.45 proportion of participants
Interval 0.17 to 0.77
|
—
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
—
|
0.17 proportion of participants
Interval 0.02 to 0.48
|
—
|
SECONDARY outcome
Timeframe: Days 0, 28, 56, 84, 140 and 220Population: 1. Proportion of Seroconversion to HTNV PsVNA by Group and by Day 2. Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day
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)
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 28
|
0.25 proportion of participants
Interval 0.03 to 0.65
|
0.25 proportion of participants
Interval 0.05 to 0.57
|
0 proportion of participants
Interval 0.0 to 0.37
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.41
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 56
|
0.33 proportion of participants
Interval 0.01 to 0.91
|
0.17 proportion of participants
Interval 0.02 to 0.48
|
0.2 proportion of participants
Interval 0.01 to 0.72
|
0.17 proportion of participants
Interval 0.02 to 0.48
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.84
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 84
|
1 proportion of participants
Interval 0.4 to 1.0
|
0.5 proportion of participants
Interval 0.21 to 0.79
|
0 proportion of participants
Interval 0.0 to 0.6
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0 proportion of participants
Interval 0.0 to 0.84
|
0.5 proportion of participants
Interval 0.01 to 0.99
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 140
|
0.27 proportion of participants
Interval 0.06 to 0.61
|
0.25 proportion of participants
Interval 0.05 to 0.57
|
0.09 proportion of participants
Interval 0.0 to 0.41
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.26
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 220
|
—
|
0.09 proportion of participants
Interval 0.0 to 0.41
|
—
|
0 proportion of participants
Interval 0.0 to 0.26
|
—
|
—
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 28
|
0 proportion of participants
Interval 0.0 to 0.37
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.37
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.41
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 56
|
0 proportion of participants
Interval 0.0 to 0.71
|
0 proportion of participants
Interval 0.0 to 0.26
|
0 proportion of participants
Interval 0.0 to 0.52
|
0.33 proportion of participants
Interval 0.1 to 0.65
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.84
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 84
|
0 proportion of participants
Interval 0.0 to 0.6
|
0.08 proportion of participants
Interval 0.0 to 0.38
|
0.75 proportion of participants
Interval 0.19 to 0.99
|
0.75 proportion of participants
Interval 0.43 to 0.95
|
0 proportion of participants
Interval 0.0 to 0.84
|
0 proportion of participants
Interval 0.0 to 0.84
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 140
|
0 proportion of participants
Interval 0.0 to 0.28
|
0 proportion of participants
Interval 0.0 to 0.26
|
0.45 proportion of participants
Interval 0.17 to 0.77
|
0.42 proportion of participants
Interval 0.15 to 0.72
|
0 proportion of participants
Interval 0.0 to 0.84
|
—
|
—
|
|
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220
|
—
|
0 proportion of participants
Interval 0.0 to 0.28
|
—
|
0.17 proportion of participants
Interval 0.02 to 0.48
|
—
|
0 proportion of participants
Interval 0.0 to 0.26
|
—
|
SECONDARY outcome
Timeframe: Days 0, 28, 56, 84, 140 and 220Population: 1. Geometric Mean Titers of HTNV PsVNA80 by Group and by Day 2. Geometric Mean Titers of PUUV PsVNA80 by Group and by Day
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
Outcome measures
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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)
n=12 Participants
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 Participants
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 (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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 Participants
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 (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 TriGrid™ 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.
|
All Groups
Total Participants from Group 1 through 6
|
|---|---|---|---|---|---|---|---|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220
|
—
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
19.09 titers
Interval 13.12 to 27.77
|
—
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 0
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 28
|
28.68 titers
Interval 9.55 to 86.11
|
20.95 titers
Interval 13.28 to 33.06
|
14.1 titers
Interval 14.1 to 14.1
|
14.84 titers
Interval 13.26 to 16.6
|
14.1 titers
Interval 14.1 to 14.1
|
15.63 titers
Interval 12.15 to 20.11
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 56
|
22.72 titers
Interval 2.92 to 177.01
|
22.06 titers
Interval 12.81 to 37.96
|
29.98 titers
Interval 5.81 to 154.64
|
17.35 titers
Interval 12.75 to 23.61
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84
|
118.48 titers
Interval 17.97 to 781.08
|
42.65 titers
Interval 18.28 to 99.51
|
15.93 titers
Interval 10.8 to 23.52
|
17.53 titers
Interval 11.77 to 26.1
|
14.1 titers
Interval 14.1 to 14.1
|
24.91 titers
Interval 0.02 to 34375.75
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 140
|
28.26 titers
Interval 14.98 to 53.32
|
22.7 titers
Interval 12.78 to 40.35
|
18.38 titers
Interval 10.18 to 33.16
|
15.93 titers
Interval 12.18 to 20.84
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220
|
—
|
15.5 titers
Interval 12.55 to 19.15
|
—
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
14.58 titers
Interval 13.55 to 15.68
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 0
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 28
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
22.36 titers
Interval 8.1 to 61.73
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 56
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
15.27 titers
Interval 12.24 to 19.05
|
30.89 titers
Interval 13.86 to 68.82
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 84
|
14.1 titers
Interval 14.1 to 14.1
|
17.7 titers
Interval 12.05 to 26.01
|
84.75 titers
Interval 12.33 to 582.34
|
69.97 titers
Interval 38.57 to 126.93
|
14.1 titers
Interval 14.1 to 14.1
|
21.57 titers
Interval 0.1 to 4786.68
|
—
|
|
Geometric Mean Titer (GMT) of the PsVNA50
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 140
|
14.1 titers
Interval 14.1 to 14.1
|
14.1 titers
Interval 14.1 to 14.1
|
41.63 titers
Interval 20.39 to 84.97
|
31.54 titers
Interval 20.28 to 49.06
|
14.1 titers
Interval 14.1 to 14.1
|
—
|
—
|
Adverse Events
Group 1: 0.6 mg HTNV - Intradermal (ID)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 2: 3.0 mg HTNV - Intramuscular (IM)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 3: 0.6 mg PUUV - Intradermal (ID)
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: 3.0 mg PUUV - Intramuscular (IM)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 participants at risk
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 (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 TriGrid™ 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)
n=12 participants at risk
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 (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 TriGrid™ 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)
n=12 participants at risk
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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGrid™ 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)
n=12 participants at risk
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 participants at risk
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.
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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 participants at risk
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 (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 TriGrid™ 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.
|
|---|---|---|---|---|---|---|
|
Investigations
ALT Elevation
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 1 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 1 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
|
Nervous system disorders
Alcohol Withdrawal Seizure
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 1 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
Other adverse events
| Measure |
Group 1: 0.6 mg HTNV - Intradermal (ID)
n=11 participants at risk
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 (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 TriGrid™ 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)
n=12 participants at risk
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 (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 TriGrid™ 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)
n=12 participants at risk
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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID): The PUUV vaccine will be administered using the ID TriGrid™ 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)
n=12 participants at risk
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 (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 TriGrid™ 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 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)
n=2 participants at risk
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.
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 TriGrid™ 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 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
n=12 participants at risk
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 (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 TriGrid™ 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.
|
|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
18.2%
2/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
50.0%
2/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
50.0%
2/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Induration (Hardness)/Swelling
|
50.0%
2/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Pain
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
27.3%
3/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
41.7%
5/12 • Number of events 12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
50.0%
1/2 • Number of events 2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Tenderness
|
50.0%
2/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
63.6%
7/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
75.0%
3/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
50.0%
6/12 • Number of events 12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
50.0%
1/2 • Number of events 2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Axillary pain or discomfort
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
9.1%
1/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
75.0%
3/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
27.3%
3/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
50.0%
2/4 • Number of events 4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
50.0%
1/2 • Number of events 2 • 6 months from last vaccination (Day 220)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Body aches/Muscular pain)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
27.3%
3/11 • Number of events 11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
8.3%
1/12 • Number of events 12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
50.0%
1/2 • Number of events 2 • 6 months from last vaccination (Day 220)
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
|
General disorders
Temperature (fever)
|
0.00%
0/8 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/8 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/7 • 6 months from last vaccination (Day 220)
|
|
General disorders
Temperature
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/11 • 6 months from last vaccination (Day 220)
|
0.00%
0/4 • 6 months from last vaccination (Day 220)
|
0.00%
0/12 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
0.00%
0/2 • 6 months from last vaccination (Day 220)
|
Additional Information
Elissa K. Thomas, Associate Director, Corporate Strategy
GenevaUSA.org
Phone: 248-802-6095
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place