Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever
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ClinicalTrials.gov Identifier: NCT02116205 |
Recruitment Status :
Completed
First Posted : April 16, 2014
Results First Posted : December 1, 2020
Last Update Posted : February 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hemorrhagic Fever With Renal Syndrome | Biological: HTNV/PUUV DNA vaccine Biological: Placebo Device: TriGrid Delivery System (TDS) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 130 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Prevention |
Official Title: | A Phase 2a Double-Blind, Dose-optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers by Electroporation for Prevention of Hemorrhagic Fever With Renal Syndrome |
Actual Study Start Date : | July 9, 2014 |
Actual Primary Completion Date : | December 7, 2016 |
Actual Study Completion Date : | July 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: Vaccine + Placebo at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 1.0 mg placebo administration on Study Day 28.
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Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Name: Hantaan Virus/Puumala Virus DNA Vaccine Biological: Placebo 0.9% sodium chloride
Other Name: Normal saline placebo Device: TriGrid Delivery System (TDS) The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Name: TriGrid Delivery System for intramuscular delivery (TDS-IM) |
Experimental: Vaccine at 1.0 mg
1.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
|
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Name: Hantaan Virus/Puumala Virus DNA Vaccine Device: TriGrid Delivery System (TDS) The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Name: TriGrid Delivery System for intramuscular delivery (TDS-IM) |
Experimental: Vaccine + Placebo at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 56 and 168. 2.0 mg placebo administration on Study Day 28.
|
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Name: Hantaan Virus/Puumala Virus DNA Vaccine Biological: Placebo 0.9% sodium chloride
Other Name: Normal saline placebo Device: TriGrid Delivery System (TDS) The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Name: TriGrid Delivery System for intramuscular delivery (TDS-IM) |
Experimental: Vaccine at 2.0 mg
2.0 mg HTNV/PUUV DNA vaccine IM-EP via TriGrid™ Delivery System (TDS) on Study Day 0, 28, 56 and 168.
|
Biological: HTNV/PUUV DNA vaccine
HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
Other Name: Hantaan Virus/Puumala Virus DNA Vaccine Device: TriGrid Delivery System (TDS) The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
Other Name: TriGrid Delivery System for intramuscular delivery (TDS-IM) |
- Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA50 [ Time Frame: Study Days 0 to 365 ]The primary endpoint will be to determine the seroconversion rates of the vaccines. Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). A PsVNA50 titer ≥ 20 is considered positive. Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies using PsVNA50. Percentages for seroconversion are based on the number of subjects presenting non-missing data.
- Number of Solicited Adverse Events (AEs) in Study Subjects [ Time Frame: The time of each injection through 14 days following the procedure ]The nature, frequency, and severity of solicited adverse events (AE) occurring from the time of each injection through 14 days following the procedure. The total number of events counts all solicited adverse events for all subjects. Subjects may have more than one solicited adverse event per body system and preferred term.
- Number of Participants With Seroconversion of HTNV and PUUV Using PsVNA80 [ Time Frame: Study Days 0 to 365 ]Seroconversion is defined as production of neutralizing antibody titers measured using a pseudovirion neutralization assay (PsVNA). Sera were collected on Days 0, 28, 56, 84, 140, 168, 196, 252, 365 and evaluated for the presence of neutralizing antibodies by using PsVNA80. Percentages for seroconversion are based on the number of subjects presenting non-missing data.

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Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy adult male or non-pregnant, non-lactating female, ages 18-49 (inclusive) at the time of screening
- Have provided written informed consent before screening
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination prior to entry into the study
- Available and able to participate for all study visits and procedures
- Females, if sexually active, are known to be at least one year post-menopausal (defined as no menses for 12 consecutive months), or willing to use an effective method of contraception (eg, hormonal contraception, diaphragm, cervical cap, intrauterine device, condom, anatomical sterility [self or partner]) from the date of screening until at least 3 months after the last injection
- Negative hantavirus pseudovirion neutralization assay (PsVNA) test result at screening
Exclusion Criteria:
- History or serologic evidence of prior infection with any hantavirus virus, or prior participation in a HTNV or PUUV vaccine trial
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- Ongoing participation in another clinical trial
- Receipt or planned receipt of any vaccination, experimental or otherwise within the period 30 days prior to the first injection through the period 60 days after Study Day 168 (booster dose; approximately 9 month period in total), with the exception of emergency use vaccinations as needed
- Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for all eligible injection sites (deltoid region) exceeds 40 mm
- Individuals in whom the ability to observe possible local reactions at the eligible injections sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
- Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the investigator based on medical history, physical exam, electrocardiogram (ECG), and/or laboratory screening test
- Pregnant or lactating female, or female who intends to become pregnant during the study period
- Administration of immunoglobulins and/or any blood products within the 120 days preceding study entry or planned administration during the study period
- Any serologic evidence of hepatitis B or C infection
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
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Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry
- For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
- Intranasal and topical steroids are allowed
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
- Syncopal episode within 12 months of screening
- Suspected or known current alcohol and/or illicit drug abuse
- Unwilling to allow storage and use of blood for future hantavirus-related research
- Any other significant finding that in the opinion of the investigator would increase the risk of the individual having an adverse outcome from participating in this study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02116205
United States, Maryland | |
Walter Reed Army Institute of Research Clinical Trials Center | |
Silver Spring, Maryland, United States, 20910 |
Principal Investigator: | Kristopher Paolino, MD | WRAIR Clinical Trials Center |
Responsible Party: | U.S. Army Medical Research and Development Command |
ClinicalTrials.gov Identifier: | NCT02116205 |
Other Study ID Numbers: |
S-14-01 2085 ( Other Identifier: WRAIR ) |
First Posted: | April 16, 2014 Key Record Dates |
Results First Posted: | December 1, 2020 |
Last Update Posted: | February 12, 2021 |
Last Verified: | February 2021 |
Hantaan virus Puumala virus HFRS |
Hantavirus Infections Hemorrhagic Fevers, Viral Hemorrhagic Fever with Renal Syndrome Syndrome Fever Disease Pathologic Processes Body Temperature Changes |
RNA Virus Infections Virus Diseases Infections Bunyaviridae Infections Vaccines Immunologic Factors Physiological Effects of Drugs |