Hantaan Virus Disease, Puumala VirusPhase 1NCT03718130

Combination HTNV and PUUV DNA Vaccine

A Phase 1 study testing Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID), Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM) and Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID) in people with Hantaan Virus Disease, Puumala Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Hantaan Virus Disease, Puumala Virus
What is being tested?: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID), Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM) and Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 1 siteUnited States
Study dates: 10 Jul 2019to 7 Oct 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
Have provided written informed consent before screening
Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination
Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.

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Available and able to participate for all study visits and procedures
Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination.
A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed > 1 year prior to screening. They must agree not to father a child until 6 months after the last vaccination. These subjects must agree to use a barrier method of birth control (eg, either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap [diaphragm or cervical/vault caps] with spermicidal foam/gel/film/cream/suppository).
Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or < 1 year of the last menses if perimenopausal. For this study, an effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly (see the Manual of Procedures [MOP] for a list of acceptable methods).
Female subjects agree to not donate eggs (ova, oocytes), and male subjects agree to not donate sperm from the start of screening until at least 6 months after the last vaccination.
Negative hantavirus PsVNA test result at screening

Who cannot join

History of prior infection with any hantavirus virus or prior participation in an HTNV, PUUV, or Andes virus vaccine trial.
Has plans to travel to an area with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission during the study.
NOTE: Refer to the MOP for information on areas with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission
History of severe local or systemic reactions to any vaccine or vaccine products or a history of severe allergic reactions.
This includes a known allergy to an aminoglycoside (eg, gentamicin, tobramycin, neomycin, and streptomycin).
Is currently participating in or plans to participate in another study involving any investigational product (eg, vaccine, drug, or biologics) or a study that involves blood drawing, and/or an invasive procedure.

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An invasive procedure includes endoscopy, bronchoscopy, or procedure requiring administration of IV contrast or removal of tissue.
Receipt or planned receipt of any live vaccination, experimental or otherwise, within the period 30 days prior to or after each vaccination and receipt or planned receipt of an inactivated vaccination, experimental or otherwise, within the period of 14 days prior to or after each vaccination.
Individuals, who based on clinical assessment by the investigator, have insufficient muscle mass to accommodate the 1 inch/25 mm penetration depth or have a skinfold thickness at eligible injection sites (deltoid region) that exceeds 40 mm.
Individuals in whom the ability to observe local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
Presence of any surgical or traumatic metal implants at the injection site (medial deltoid muscles or overlying skin).
Screening laboratory results that are outside of the normal range (exceptions listed below) within 56 days prior to enrollment
Hemoglobin > 11.0 g/dL for women; > 12.9 g/dL for men
CBC (WBC and platelet) with differential either within institutional normal range or Grade 1 deviation from normal and deemed clinically insignificant
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 1.25x upper limit of normal (ULN)
Serum creatinine ≤ ULN
Subjects with autoimmune disorders or chronic inflammatory disorders with a potential autoimmune correlation.
Receipt of immunoglobulins and/or any blood products within the 120 days preceding screening or planned administration during the study period
Donation of blood to a blood bank within 56 days prior to screening and at any time during the study period.
Subject seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (anti-HCV).
Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, or use of anticancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to screening.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Maryland
Baltimore, Maryland, 21201

Other trials in United States

About this study

Official title: A Phase 1, Randomized Trial to Assess the Safety, Reactogenicity, and Immunogenicity of a Combination HTNV and PUUV DNA Vaccine Candidate Administered by Electroporation

To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults

Read the detailed description

The development of DNA (deoxyribonucleic acid) vaccines, such as those to be utilized in this study, is based on the observation that antigen-encoding DNA plasmids can induce both cellular and humoral immune responses against various viral and bacterial pathogens. DNA vaccines are perceived as having a number of potential advantages over other types of vaccines. For example, DNA vaccines are easily constructed by recombinant technology; easily and inexpensively manufactured as a well-characterized molecule [DNA plasmid]; and at boost, not eliminated by prior immune response to the carrier or vector. Furthermore, as nonliving vaccines, they cannot lead to infection. The object of DNA vaccination is to deliver DNA into the nuclei of cells capable of presenting the encoded antigen to immune reactive cells that can elicit an immune response.

The study will enroll 6 randomized groups of 12 subjects each, for a total of 72 subjects. This approach will ensure at least 60 subjects complete all vaccinations at around 10 subjects per group, taking possible attrition into account. Subjects will receive one dose of vaccine on each of Days 0, 28, and 56 either intramuscularly or intradermally by electroporation and will be followed until Day 220.

Conditions: Hantaan Virus Disease, Puumala Virus
Being tested: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID), Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM), Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID), Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM), Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Medical subject headings: Hantavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Combination product
Also called HTNV vaccine using TDS 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.
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)Combination product
Also called HTNV vaccine using TDS 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Combination product
Also called PUUV vaccine using TDS 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.
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)Combination product
Also called PUUV vaccine using the TDS 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.
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Combination product
Also called HTNV/PUUV vaccines using the TDS 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.
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)Combination product
Also called HTNV/PUUV vaccines using the TDS 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.

Study groups in NCT03718130
Study group	Role	What they receive
Group 1: 0.6 mg HTNV - Intradermal (ID)	Experimental	0.1 mL 6.0 mg/mL HTNV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID 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. Receives: Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Group 2: 3.0 mg HTNV - Intramuscular (IM)	Experimental	0.5 mL 6.0 mg/mL HTNV DNA + 0.5 mL 0.9% saline (IM) The HTNV and PUUV DNA vaccines will be administered using the IM 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. Receives: Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Group 3: 0.6 mg PUUV - Intradermal (ID)	Experimental	0.1 mL 6.0 mg/mL PUUV DNA + 0.1 mL 0.9% saline (ID) The HTNV and PUUV DNA vaccines will be administered using the ID 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. Receives: Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Group 4: 3.0 mg PUUV - Intramuscular (IM)	Experimental	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. Receives: Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)
Group 5: 1.2 mg HTNV/PUUV (0.6 mg each) - Intradermal (ID)	Experimental	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. Receives: Combination Product: Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)
Group 6: 6.0 mg HTNV/PUUV (3.0 mg each) - Intramuscular (IM)	Experimental	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. Receives: Combination Product: Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)

What is being measured

The primary outcome is the main question the study is designed to answer.

Summary of Solicited Local Adverse Events (AEs)
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Measured: Days 0-14 after injection
Summary of Solicited Systemic Adverse Events (AEs)
Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Measured: Days 0-14 after injection

Secondary outcomes (4)

Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Subjects experiencing vaccine-related unsolicited AEs from the time of the first injection through 28 days following each injection
Measured: Days 0-28 after injection
Proportion of Seropositive Subjects
Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point
Measured: Days 0, 28, 56, 84, 140 and 220
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Determination of the final overall rate of serconversion over all scheduled time points to study completion for each study group. Seroconversion is defined as a post-vaccination HTNV- or PUUV-specific titer of ≥1:40, or a minimum four-fold rise compared to baseline titer, and all study volunteers will begin the study with a baseline titer <20 (ie, seronegative)
Measured: Days 0, 28, 56, 84, 140 and 220
Geometric Mean Titer (GMT) of the PsVNA50
GMT of the PsVNA50 for HTNV- and PUUV-specific neutralizing antibodies at each schedule time point for each study group and over all time points for each study group
Measured: Days 0, 28, 56, 84, 140 and 220

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jul 20197 Oct 2022

First posted24 Oct 2018
Study start10 Jul 2019
Primary completion7 Oct 2022
Study completion7 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hantaan Virus Disease, Puumala VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Model description: 6 groups of 12 subjects each will receive varying vaccine dosages and vaccine candidate combinations
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03718130
Sponsor's protocol ID: S-15-39
Status last verified: Jun 2025
First submitted: 18 Oct 2018
Last updated: 26 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Randomized Trial to Assess the Safety, Reactogenicity, and Immunogenicity of a Combination HTNV and PUUV DNA Vaccine Candidate Administered by Electroporation
ClinicalTrials.gov ID: NCT03718130
Acronym / sponsor ID: S-15-39
Conditions: Hantaan Virus Disease, Puumala Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), The Geneva Foundation, US Army Medical Research Institute of Infectious Diseases, Ichor Medical Systems Incorporated
Study start: 10 Jul 2019 (actual)
Primary completion: 7 Oct 2022 (actual)
Study completion: 7 Oct 2022 (actual)
First posted: 24 Oct 2018 (actual)
Results: Posted 26 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 6
Model description: 6 groups of 12 subjects each will receive varying vaccine dosages and vaccine candidate combinations

Arm	Type	Receives
Group 1: 0.6 mg HTNV - Intradermal (ID)	Experimental	Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 2: 3.0 mg HTNV - Intramuscular (IM)	Experimental	Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 3: 0.6 mg PUUV - Intradermal (ID)	Experimental	Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
Group 4: 3.0 mg PUUV - Intramuscular (IM)	Experimental	Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (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 (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)	Experimental	Combination Product: Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (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 (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)	Experimental	Combination Product: Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (12 listed)

Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
Have provided written informed consent before screening
Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination
Available and able to participate for all study visits and procedures

Key exclusion criteria (21 listed)

History of prior infection with any hantavirus virus or prior participation in an HTNV, PUUV, or Andes virus vaccine trial.
Has plans to travel to an area with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission during the study.
NOTE: Refer to the MOP for information on areas with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission
History of severe local or systemic reactions to any vaccine or vaccine products or a history of severe allergic reactions.
Is currently participating in or plans to participate in another study involving any investigational product (eg, vaccine, drug, or biologics) or a study that involves blood drawing, and/or an invasive procedure.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Also: HTNV vaccine using TDS IDThe 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.	Combination product	Group 1: 0.6 mg HTNV - Intradermal (ID)
Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)Also: HTNV vaccine using TDS IMThe 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.	Combination product	Group 2: 3.0 mg HTNV - Intramuscular (IM)
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Also: PUUV vaccine using TDS IDThe 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.	Combination product	Group 3: 0.6 mg PUUV - Intradermal (ID)
Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)Also: PUUV vaccine using the TDS IMThe 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.	Combination product	Group 4: 3.0 mg PUUV - Intramuscular (IM)
Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)Also: HTNV/PUUV vaccines using the TDS IDThe 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.	Combination product	Group 5: 1.2 mg HTNV/PUUV (0.6 mg each) - Intradermal (ID)
Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)Also: HTNV/PUUV vaccines using the TDS IMThe 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.	Combination product	Group 6: 6.0 mg HTNV/PUUV (3.0 mg each) - Intramuscular (IM)

Primary outcome

Summary of Solicited Local Adverse Events (AEs)
Time frame: Days 0-14 after injection
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Summary of Solicited Systemic Adverse Events (AEs)
Time frame: Days 0-14 after injection
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

4 secondary outcomes

Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Time frame: Days 0-28 after injection
Proportion of Seropositive Subjects
Time frame: Days 0, 28, 56, 84, 140 and 220
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Time frame: Days 0, 28, 56, 84, 140 and 220
Geometric Mean Titer (GMT) of the PsVNA50
Time frame: Days 0, 28, 56, 84, 140 and 220

Results and safety

Results posted to the registry on 26 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: 0.6 mg HTNV - Intradermal (ID)	11	0
Group 2: 3.0 mg HTNV - Intramuscular (IM)	12	11
Group 3: 0.6 mg PUUV - Intradermal (ID)	12	0
Group 4: 3.0 mg PUUV - Intramuscular (IM)	12	12
Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)	2	0
Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)	12	12

Primary outcome: Summary of Solicited Local Adverse Events (AEs)

Time frame: Days 0-14 after injection. Count of participants. Unit: Participants

Measure	Group 1: 0.6 mg HTNV - Intradermal (ID) n = 11	Group 2: 3.0 mg HTNV - Intramuscular (IM) n = 12	Group 3: 0.6 mg PUUV - Intradermal (ID) n = 12	Group 4: 3.0 mg PUUV - Intramuscular (IM) n = 12	Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) n = 2	Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) n = 12
Dose 1 : Ecchymosis: None	8	11	12	9	2	9
Dose 1 : Ecchymosis: Mild	3	0	0	2	0	2
Dose 1 : Ecchymosis: Moderate	0	1	0	1	0	1
Dose 1 : Ecchymosis: Severe	0	0	0	0	0	0
Dose 1 : Erythema: None	6	11	6	12	1	9
Dose 1 : Erythema: Mild	2	1	1	0	1	1
Dose 1 : Erythema: Moderate	2	0	3	0	0	1
Dose 1 : Erythema: Severe	1	0	2	0	0	1

Population analysed: Summary of solicited local AE for Groups 1 through Group 6

Primary outcome: Summary of Solicited Systemic Adverse Events (AEs)

Time frame: Days 0-14 after injection. Count of participants. Unit: Participants

Measure	Group 1: 0.6 mg HTNV - Intradermal (ID) n = 11	Group 2: 3.0 mg HTNV - Intramuscular (IM) n = 12	Group 3: 0.6 mg PUUV - Intradermal (ID) n = 12	Group 4: 3.0 mg PUUV - Intramuscular (IM) n = 12	Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID) n = 2	Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM) n = 12
Dose 1: Axillary Pain or Discomfort: None	8	10	12	12	2	10
Dose 1: Axillary Pain or Discomfort: Mild	3	2	0	0	0	2
Dose 1: Axillary Pain or Discomfort: Moderate	0	0	0	0	0	0
Dose 1: Axillary Pain or Discomfort: Severe	0	0	0	0	0	0
Dose 1: Fatigue: None	7	8	8	9	2	7
Dose 1: Fatigue: Mild	2	3	1	2	0	4
Dose 1: Fatigue: Moderate	1	1	3	1	0	1
Dose 1: Fatigue: Severe	1	0	0	0	0	0

Population analysed: Summary of solicited systemic AE by Group and Dose Number, for Groups 1 through Group 6

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months from last vaccination (Day 220). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: 0.6 mg HTNV - Intradermal (ID)	0 of 11 (0%)	10 of 11 (90.9%)	0 of 11
Group 2: 3.0 mg HTNV - Intramuscular (IM)	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12
Group 3: 0.6 mg PUUV - Intradermal (ID)	1 of 12 (8.3%)	7 of 12 (58.3%)	0 of 12
Group 4: 3.0 mg PUUV - Intramuscular (IM)	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)	0 of 2 (0%)	1 of 2 (50%)	0 of 2
Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)	0 of 12 (0%)	9 of 12 (75%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Kirsten E Lyke, MD principal investigator

University of Maryland

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Summary of Solicited Local Adverse Events (AEs) (time frame: Days 0-14 after injection). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03718130.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.