Combination HTNV and PUUV DNA Vaccine
A Phase 1, Randomized Trial to Assess the Safety, Reactogenicity, and Immunogenicity of a Combination HTNV and PUUV DNA Vaccine Candidate Administered by Electroporation
1 other identifier
interventional
61
1 country
1
Brief Summary
To evaluate the safety and reactogenicity of the hantaan virus (HTNV), puumala virus (PUUV), and combination HTNV/PUUV DNA vaccine candidates delivered to healthy adults
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2018
CompletedFirst Posted
Study publicly available on registry
October 24, 2018
CompletedStudy Start
First participant enrolled
July 10, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 7, 2022
CompletedResults Posted
Study results publicly available
June 26, 2025
CompletedJune 26, 2025
June 1, 2025
3.2 years
October 18, 2018
November 21, 2023
June 9, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Summary of Solicited Local Adverse Events (AEs)
Summary of solicited local AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Days 0-14 after injection
Summary of Solicited Systemic Adverse Events (AEs)
Summary of solicited systemic AEs occurring from the time of each injection through 14 days to evaluate the safety and reactogenicity of the HTNV, PUUV and combination HTNV/PUUV DNA vaccines
Days 0-14 after injection
Secondary Outcomes (4)
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
Days 0-28 after injection
Proportion of Seropositive Subjects
Days 0, 28, 56, 84, 140 and 220
Final Overall Rate of Seroconversion Over All Scheduled Time Points
Days 0, 28, 56, 84, 140 and 220
Geometric Mean Titer (GMT) of the PsVNA50
Days 0, 28, 56, 84, 140 and 220
Study Arms (6)
Group 1: 0.6 mg HTNV - Intradermal (ID)
EXPERIMENTAL0.1 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)
EXPERIMENTAL0.5 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)
EXPERIMENTAL0.1 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)
EXPERIMENTAL0.5 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)
EXPERIMENTAL0.1 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)
EXPERIMENTAL0.5 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.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.
- Available and able to participate for all study visits and procedures
- Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination.
- A sexually active man is defined as one whose partner is a woman of childbearing potential (see definition below) and has not had a vasectomy performed \> 1 year prior to screening. They must agree not to father a child until 6 months after the last vaccination. These subjects must agree to use a barrier method of birth control (eg, either condom with spermicidal foam/gel/film/cream or partner usage of occlusive cap \[diaphragm or cervical/vault caps\] with spermicidal foam/gel/film/cream/suppository).
- Women of childbearing potential are defined as those who have not been sterilized via tubal ligation, bilateral oophorectomy, bilateral salpingectomy, hysterectomy, or successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with history of documented radiological confirmation test at least 90 days after the procedure and are still menstruating or \< 1 year of the last menses if perimenopausal. For this study, an effective contraceptive method is defined as one that results in a failure rate of less than 1% per year when it is used consistently and correctly (see the Manual of Procedures \[MOP\] for a list of acceptable methods).
- Female subjects agree to not donate eggs (ova, oocytes), and male subjects agree to not donate sperm from the start of screening until at least 6 months after the last vaccination.
- Negative hantavirus PsVNA test result at screening
- History of prior infection with any hantavirus virus or prior participation in an HTNV, PUUV, or Andes virus vaccine trial.
- Has plans to travel to an area with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission during the study.
- NOTE: Refer to the MOP for information on areas with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission
- History of severe local or systemic reactions to any vaccine or vaccine products or a history of severe allergic reactions.
- This includes a known allergy to an aminoglycoside (eg, gentamicin, tobramycin, neomycin, and streptomycin).
- Is currently participating in or plans to participate in another study involving any investigational product (eg, vaccine, drug, or biologics) or a study that involves blood drawing, and/or an invasive procedure.
- An invasive procedure includes endoscopy, bronchoscopy, or procedure requiring administration of IV contrast or removal of tissue.
- Receipt or planned receipt of any live vaccination, experimental or otherwise, within the period 30 days prior to or after each vaccination and receipt or planned receipt of an inactivated vaccination, experimental or otherwise, within the period of 14 days prior to or after each vaccination.
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Maryland
Baltimore, Maryland, 21201, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Elissa K. Thomas, Associate Director, Corporate Strategy
- Organization
- GenevaUSA.org
Study Officials
- PRINCIPAL INVESTIGATOR
Kirsten E Lyke, MD
University of Maryland
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2018
First Posted
October 24, 2018
Study Start
July 10, 2019
Primary Completion
October 7, 2022
Study Completion
October 7, 2022
Last Updated
June 26, 2025
Results First Posted
June 26, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share