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CompletedNCT03718130Updated Jun 26, 2025Results posted

Combination HTNV and PUUV DNA Vaccine

A Phase 1 interventional study of Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID) and Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM) in Hantaan Virus Disease, Puumala Virus, sponsored by U.S. Army Medical Research and Development Command. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-26.

Sponsored by U.S. Army Medical Research and Development Command · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Hantaan Virus Disease, Puumala Virus
03

In context

Lead sponsor

U.S. Army Medical Research and Development Command is the lead sponsor of 151 studies on the registry; 8 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at time of screening
  • Have demonstrated adequate comprehension of the protocol by achieving a score of at least 80% correct on a short multiple-choice quiz. Individuals who fail to achieve a passing score on the initial quiz will be given the opportunity to retest after a review of the protocol information. Individuals who fail the quiz for the second time will not be enrolled.
  • Have provided written informed consent before screening

  • Subject is in good health as determined by past medical history, medication use, and abbreviated physical examination

    • Good health is defined by the absence of any medical condition described in the exclusion criteria in a subject with a normal abbreviated physical examination including vital signs. If the subject has another current, ongoing medical condition, the condition cannot meet any of the following criteria: (1) first diagnosed within 3 months of enrollment, (2) is worsening in terms of clinical outcome in last 6 months, or (3) involves need for medication that may pose a risk to subject's safety or impede assessment of adverse events or immunogenicity if they participate in the study.
    • An abbreviated physical examination differs from a complete physical examination in that it does not include a genitourinary and rectal examination.
  • Available and able to participate for all study visits and procedures

  • Sexually active men and women of childbearing potential must agree to use an effective method of contraception from 30 days prior to the first study vaccination until 6 months after the last study vaccination.

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

Exclusion criteria

Exclusion Criteria:

  • History of prior infection with any hantavirus virus or prior participation in an HTNV, PUUV, or Andes virus vaccine trial.
  • Has plans to travel to an area with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission during the study.

NOTE: Refer to the MOP for information on areas with endemic Hantaan, Puumala, Seoul, and Dobrava virus transmission

  • History of severe local or systemic reactions to any vaccine or vaccine products or a history of severe allergic reactions.

    • This includes a known allergy to an aminoglycoside (eg, gentamicin, tobramycin, neomycin, and streptomycin).

  • Is currently participating in or plans to participate in another study involving any investigational product (eg, vaccine, drug, or biologics) or a study that involves blood drawing, and/or an invasive procedure.

    • An invasive procedure includes endoscopy, bronchoscopy, or procedure requiring administration of IV contrast or removal of tissue.
  • Receipt or planned receipt of any live vaccination, experimental or otherwise, within the period 30 days prior to or after each vaccination and receipt or planned receipt of an inactivated vaccination, experimental or otherwise, within the period of 14 days prior to or after each vaccination.
  • Individuals, who based on clinical assessment by the investigator, have insufficient muscle mass to accommodate the 1 inch/25 mm penetration depth or have a skinfold thickness at eligible injection sites (deltoid region) that exceeds 40 mm.
  • Individuals in whom the ability to observe local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
  • Presence of any surgical or traumatic metal implants at the injection site (medial deltoid muscles or overlying skin).

  • Screening laboratory results that are outside of the normal range (exceptions listed below) within 56 days prior to enrollment

    • Hemoglobin > 11.0 g/dL for women; > 12.9 g/dL for men
    • CBC (WBC and platelet) with differential either within institutional normal range or Grade 1 deviation from normal and deemed clinically insignificant
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 1.25x upper limit of normal (ULN)
    • Serum creatinine ≤ ULN
  • Subjects with autoimmune disorders or chronic inflammatory disorders with a potential autoimmune correlation.
  • Receipt of immunoglobulins and/or any blood products within the 120 days preceding screening or planned administration during the study period
  • Donation of blood to a blood bank within 56 days prior to screening and at any time during the study period.
  • Subject seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies (anti-HCV).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection, or use of anticancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to screening.
05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Hantaan virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)

  • Experimental
    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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Combination Product: Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)

Interventions

  • Combination productHantaan 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.

    Also known as: HTNV vaccine using TDS ID

  • Combination productHantaan 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.

    Also known as: HTNV vaccine using TDS IM

  • Combination productPuumala 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.

    Also known as: PUUV vaccine using TDS ID

  • Combination productPuumala 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.

    Also known as: PUUV vaccine using the TDS IM

  • Combination productHantaan/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.

    Also known as: HTNV/PUUV vaccines using the TDS ID

  • Combination productHantaan/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 (electroporation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.

    Also known as: HTNV/PUUV vaccines using the TDS IM

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Days 0-14 after injection

  2. 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

    Time frame: Days 0-14 after injection

Secondary outcomes

  1. 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

    Time frame: Days 0-28 after injection

  2. Proportion of Seropositive Subjects

    Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point

    Time frame: Days 0, 28, 56, 84, 140 and 220

  3. 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)

    Time frame: Days 0, 28, 56, 84, 140 and 220

  4. 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

    Time frame: Days 0, 28, 56, 84, 140 and 220

07

Results

Posted Jun 26, 2025

Participant flow

Participant flow — Overall Study
MilestoneGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Started11121212212
Completed011012012
Not completed11112020

Outcome measures

PrimarySummary 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

Time frame:
Days 0-14 after injection
Reported as:
Count of participants · Participants
Summary of Solicited Local Adverse Events (AEs)
ParticipantsGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Dose 1 : Ecchymosis — None81112929
Dose 1 : Ecchymosis — Mild300202
Dose 1 : Ecchymosis — Moderate010101
Dose 1 : Ecchymosis — Severe000000
Dose 1 : Erythema — None61161219
Dose 1 : Erythema — Mild211011
Dose 1 : Erythema — Moderate203001
Dose 1 : Erythema — Severe102001
Dose 1 : Induration (Hardness)/Swelling — None71191019
Dose 1 : Induration (Hardness)/Swelling — Mild310110
Dose 1 : Induration (Hardness)/Swelling — Moderate002101
Dose 1 : Induration (Hardness)/Swelling — Severe101002
Dose 1 : Pain — None9312324
Dose 1 : Pain — Mild280806
Dose 1 : Pain — Moderate010102
Dose 1 : Pain — Severe000000
Dose 1 : Tenderness — None447315
Dose 1 : Tenderness — Mild655815
Dose 1 : Tenderness — Moderate130102
Dose 1 : Tenderness — Severe000000
Dose 2 : Ecchymosis — None7881026
Dose 2 : Ecchymosis — Mild010001
Dose 2 : Ecchymosis — Moderate120200
Dose 2 : Ecchymosis — Severe000000
Dose 2 : Erythema — None5106926
Dose 2 : Erythema — Mild100100
Dose 2 : Erythema — Moderate111101
Dose 2 : Erythema — Severe101100
Dose 2 : Induration (Hardness)/Swelling — None61061226
Dose 2 : Induration (Hardness)/Swelling — Mild100000
Dose 2 : Induration (Hardness)/Swelling — Moderate012001
Dose 2 : Induration (Hardness)/Swelling — Severe100000
Dose 2 : Pain — None768722
Dose 2 : Pain — Mild050405
Dose 2 : Pain — Moderate100100
Dose 2 : Pain — Severe000000
Dose 2 : Tenderness — None557422
Dose 2 : Tenderness — Mild241704
Dose 2 : Tenderness — Moderate120101
Dose 2 : Tenderness — Severe000000
Dose 3 : Ecchymosis — None3941122
Dose 3 : Ecchymosis — Mild110000
Dose 3 : Ecchymosis — Moderate010100
Dose 3 : Ecchymosis — Severe000000
Dose 3 : Erythema — None21121222
Dose 3 : Erythema — Mild000000
Dose 3 : Erythema — Moderate101000
Dose 3 : Erythema — Severe101000
Dose 3 : Induration (Hardness)/Swelling — None21131222
Dose 3 : Induration (Hardness)/Swelling — Mild100000
Dose 3 : Induration (Hardness)/Swelling — Moderate000000
Dose 3 : Induration (Hardness)/Swelling — Severe101000
Dose 3 : Pain — None384721
Dose 3 : Pain — Mild030501
Dose 3 : Pain — Moderate100000
Dose 3 : Pain — Severe000000
Dose 3 : Tenderness — None241621
Dose 3 : Tenderness — Mild162601
Dose 3 : Tenderness — Moderate111000
Dose 3 : Tenderness — Severe000000
PrimarySummary 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

Time frame:
Days 0-14 after injection
Reported as:
Count of participants · Participants
Summary of Solicited Systemic Adverse Events (AEs)
ParticipantsGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Dose 1: Axillary Pain or Discomfort — None8101212210
Dose 1: Axillary Pain or Discomfort — Mild320002
Dose 1: Axillary Pain or Discomfort — Moderate000000
Dose 1: Axillary Pain or Discomfort — Severe000000
Dose 1: Fatigue — None788927
Dose 1: Fatigue — Mild231204
Dose 1: Fatigue — Moderate113101
Dose 1: Fatigue — Severe100000
Dose 1: Headache — None710101029
Dose 1: Headache — Mild310102
Dose 1: Headache — Moderate112101
Dose 1: Headache — Severe000000
Dose 1: Lymphadenopathy — None10111212212
Dose 1: Lymphadenopathy — Mild110000
Dose 1: Lymphadenopathy — Moderate000000
Dose 1: Lymphadenopathy — Severe000000
Dose 1: Myalgia (Body aches/Muscular Pain) — None10611927
Dose 1: Myalgia (Body aches/Muscular Pain) — Mild141103
Dose 1: Myalgia (Body aches/Muscular Pain) — Moderate020102
Dose 1: Myalgia (Body aches/Muscular Pain) — Severe000100
Dose 1: Tachypnea — None11121212212
Dose 1: Tachypnea — Mild000000
Dose 1: Tachypnea — Moderate000000
Dose 1: Tachypnea — Severe000000
Dose 1: Temperature — None11111211212
Dose 1: Temperature — Mild000000
Dose 1: Temperature — Moderate010100
Dose 1: Temperature — Severe000000
Dose 2: Axillary Pain or Discomfort — None61181027
Dose 2: Axillary Pain or Discomfort — Mild100200
Dose 2: Axillary Pain or Discomfort — Moderate100000
Dose 2: Axillary Pain or Discomfort — Severe000000
Dose 2: Fatigue — None5871026
Dose 2: Fatigue — Mild231201
Dose 2: Fatigue — Moderate100000
Dose 2: Fatigue — Severe000000
Dose 2: Headache — None4971127
Dose 2: Headache — Mild411100
Dose 2: Headache — Moderate010000
Dose 2: Headache — Severe000000
Dose 2: Lymphadenopathy — None81181227
Dose 2: Lymphadenopathy — Mild000000
Dose 2: Lymphadenopathy — Moderate000000
Dose 2: Lymphadenopathy — Severe000000
Dose 2: Myalgia (Body aches/Muscular pain) — None878925
Dose 2: Myalgia (Body aches/Muscular pain) — Mild040201
Dose 2: Myalgia (Body aches/Muscular pain) — Moderate000101
Dose 2: Myalgia (Body aches/Muscular pain) — Severe000000
Dose 2: Tachypnea — None81181227
Dose 2: Tachypnea — Mild000000
Dose 2: Tachypnea — Moderate000000
Dose 2: Tachypnea — Severe000000
Dose 2: Temperature (fever) — None81181227
Dose 2: Temperature (fever) — Mild000000
Dose 2: Temperature (fever) — Moderate000000
Dose 2: Temperature (fever) — Severe000000
Dose 3: Axillary pain or discomfort — None31141222
Dose 3: Axillary pain or discomfort — Mild000000
Dose 3: Axillary pain or discomfort — Moderate100000
Dose 3: Axillary pain or discomfort — Severe000000
Dose 3: Fatigue — None31011122
Dose 3: Fatigue — Mild113100
Dose 3: Fatigue — Moderate000000
Dose 3: Fatigue — Severe000000
Dose 3: Headache — None3821221
Dose 3: Headache — Mild121001
Dose 3: Headache — Moderate011000
Dose 3: Headache — Severe000000
Dose 3: Lymphadenopathy — None41141222
Dose 3: Lymphadenopathy — Mild000000
Dose 3: Lymphadenopathy — Moderate000000
Dose 3: Lymphadenopathy — Severe000000
Dose 3: Myalgia (Body aches/Muscular pain) — None4841121
Dose 3: Myalgia (Body aches/Muscular pain) — Mild030101
Dose 3: Myalgia (Body aches/Muscular pain) — Moderate000000
Dose 3: Myalgia (Body aches/Muscular pain) — Severe000000
Dose 3: Tachypnea — None41141222
Dose 3: Tachypnea — Mild000000
Dose 3: Tachypnea — Moderate000000
Dose 3: Tachypnea — Severe000000
Dose 3: Temperature (fever) — None41141222
Dose 3: Temperature (fever) — Mild000000
Dose 3: Temperature (fever) — Moderate000000
Dose 3: Temperature (fever) — Severe000000
SecondarySubjects 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

Time frame:
Days 0-28 after injection
Reported as:
Count of participants · Participants
Subjects Experiencing Vaccine-related Unsolicited Adverse Events (AEs)
ParticipantsGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)All Groups
Pruritus4020006
Sore Throat0101013
COVID-191000102
Lightheadedness0100012
Muscle pain or spasms1010002
Viral illness/colds0110002
Back Pain1000001
Bacterial vaginitis1000001
Increased respiration0100001
Vomiting0100001
Ulcerative colitis0100001
Lump in armpit0100001
Constipation0100001
AST elevation (Grade 3)0010001
ALT elevation0010011
Seizure0010001
Scabbing0010001
Pus0010001
Influenza0001001
Nausea0001001
Fever0001001
Painful urination0000011
Nerve pain in limb0000011
SecondaryProportion of Seropositive Subjects

Determination of seropositive subjects (defined as PsVNA50 ≥ 1:20) at each scheduled time point

Time frame:
Days 0, 28, 56, 84, 140 and 220
Reported as:
Number · proportion of participants
Proportion of Seropositive Subjects
proportion of participantsGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Day 00 (0 to 0.28)0 (0 to 0.26)0 (0 to 0.26)0 (0 to 0.26)0 (0 to 0.84)0.08 (0 to 0.38)
Day 280.63 (0.24 to 0.91)0.42 (0.15 to 0.72)0.13 (0 to 0.53)0.08 (0 to 0.38)0 (0 to 0.84)0.14 (0 to 0.58)
Day 560.67 (0.09 to 0.99)0.58 (0.28 to 0.85)0.4 (0.05 to 0.85)0.33 (0.1 to 0.65)0 (0 to 0.84)0.5 (0.01 to 0.99)
Day 841 (0.4 to 1)0.75 (0.43 to 0.95)0.75 (0.19 to 0.99)0.33 (0.1 to 0.65)0 (0 to .84)0.5 (0.01 to 0.99)
Day 1400.73 (0.39 to 0.94)0.5 (0.21 to 0.79)0.09 (0 to 0.41)0.17 (0.02 to 0.48)0 (0 to 0.84)—
Day 220—0.45 (0.17 to 0.77)—0.08 (0 to 0.38)—0.17 (0.02 to 0.48)
SecondaryFinal 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)

Time frame:
Days 0, 28, 56, 84, 140 and 220
Reported as:
Number · proportion of participants
Final Overall Rate of Seroconversion Over All Scheduled Time Points
proportion of participantsGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 280.25 (0.03 to 0.65)0.25 (0.05 to 0.57)0 (0 to 0.37)0 (0 to 0.26)0 (0 to 0.84)0 (0 to 0.41)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 560.33 (0.01 to 0.91)0.17 (0.02 to 0.48)0.2 (0.01 to 0.72)0.17 (0.02 to 0.48)0 (0 to 0.84)0 (0 to 0.84)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 841 (0.4 to 1)0.5 (0.21 to 0.79)0 (0 to 0.6)0.08 (0 to 0.38)0 (0 to 0.84)0.5 (0.01 to 0.99)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 1400.27 (0.06 to 0.61)0.25 (0.05 to 0.57)0.09 (0 to 0.41)0.08 (0 to 0.38)0 (0 to 0.84)0 (0 to 0.26)
Proportion of Seroconversion to HTNV PsVNA by Group and by Day: Day 220—0.09 (0 to 0.41)—0 (0 to 0.26)——
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 280 (0 to 0.37)0 (0 to 0.26)0 (0 to 0.37)0.08 (0 to 0.38)0 (0 to 0.84)0 (0 to 0.41)
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 560 (0 to 0.71)0 (0 to 0.26)0 (0 to 0.52)0.33 (0.1 to 0.65)0 (0 to 0.84)0 (0 to 0.84)
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 840 (0 to 0.6)0.08 (0 to 0.38)0.75 (0.19 to 0.99)0.75 (0.43 to 0.95)0 (0 to 0.84)0 (0 to 0.84)
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 1400 (0 to 0.28)0 (0 to 0.26)0.45 (0.17 to 0.77)0.42 (0.15 to 0.72)0 (0 to 0.84)—
Proportion of Seroconversion to PUUV PsVNA80 by Group and by Day: Day 220—0 (0 to 0.28)—0.17 (0.02 to 0.48)—0 (0 to 0.26)
SecondaryGeometric 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

Time frame:
Days 0, 28, 56, 84, 140 and 220
Reported as:
Geometric mean · titers
Geometric Mean Titer (GMT) of the PsVNA50
titersGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 014.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 2828.68 (9.55 to 86.11)20.95 (13.28 to 33.06)14.1 (14.1 to 14.1)14.84 (13.26 to 16.6)14.1 (14.1 to 14.1)15.63 (12.15 to 20.11)
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 5622.72 (2.92 to 177.01)22.06 (12.81 to 37.96)29.98 (5.81 to 154.64)17.35 (12.75 to 23.61)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 84118.48 (17.97 to 781.08)42.65 (18.28 to 99.51)15.93 (10.8 to 23.52)17.53 (11.77 to 26.1)14.1 (14.1 to 14.1)24.91 (0.02 to 34375.75)
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 14028.26 (14.98 to 53.32)22.7 (12.78 to 40.35)18.38 (10.18 to 33.16)15.93 (12.18 to 20.84)14.1 (14.1 to 14.1)—
Geometric Mean Titers of HTNV PsVNA80 by Group and by Day: Day 220—15.5 (12.55 to 19.15)—14.1 (14.1 to 14.1)—14.58 (13.55 to 15.68)
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 014.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 2814.1 (14.1 to 14.1)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)22.36 (8.1 to 61.73)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 5614.1 (14.1 to 14.1)14.1 (14.1 to 14.1)15.27 (12.24 to 19.05)30.89 (13.86 to 68.82)14.1 (14.1 to 14.1)14.1 (14.1 to 14.1)
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 8414.1 (14.1 to 14.1)17.7 (12.05 to 26.01)84.75 (12.33 to 582.34)69.97 (38.57 to 126.93)14.1 (14.1 to 14.1)21.57 (0.1 to 4786.68)
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 14014.1 (14.1 to 14.1)14.1 (14.1 to 14.1)41.63 (20.39 to 84.97)31.54 (20.28 to 49.06)14.1 (14.1 to 14.1)—
Geometric Mean Titers of PUUV PsVNA80 by Group and by Day: Day 220—14.1 (14.1 to 14.1)—19.09 (13.12 to 27.77)—14.1 (14.1 to 14.1)

Adverse events

Collected over 6 months from last vaccination (Day 220). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group 1: 0.6 mg HTNV - Intradermal (ID)0/11 (0%)0/11 (0%)10/11 (90.9%)
Group 2: 3.0 mg HTNV - Intramuscular (IM)0/12 (0%)0/12 (0%)11/12 (91.7%)
Group 3: 0.6 mg PUUV - Intradermal (ID)0/12 (0%)1/12 (8.3%)7/12 (58.3%)
Group 4: 3.0 mg PUUV - Intramuscular (IM)0/12 (0%)0/12 (0%)10/12 (83.3%)
Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)0/2 (0%)0/2 (0%)1/2 (50%)
Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)0/12 (0%)0/12 (0%)9/12 (75%)
Most frequent serious events
Most frequent serious events
EventGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
ALT ElevationInvestigations0/110/121/120/120/20/12
SeizureNervous system disorders0/110/121/120/120/20/12
Alcohol Withdrawal SeizureNervous system disorders0/110/121/120/120/20/12
Most frequent other events
Showing 10 of 36
Most frequent other events
EventGroup 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)
PainGeneral disorders2/119/120/129/120/28/12
TendernessGeneral disorders7/118/125/129/121/27/12
TendernessGeneral disorders2/47/113/46/120/21/2
FatigueGeneral disorders1/41/113/41/120/20/2
PainGeneral disorders1/85/110/85/120/25/7
TendernessGeneral disorders3/86/111/88/120/25/7
ErythemaSkin and subcutaneous tissue disorders5/111/126/120/121/23/12
Induration (Hardness)/SwellingGeneral disorders4/111/123/122/121/23/12
ErythemaSkin and subcutaneous tissue disorders2/40/112/40/120/20/2
Induration (Hardness)/SwellingGeneral disorders2/40/111/40/120/20/2

Baseline characteristics

Age, Continuous
Age, Continuous(years)Group 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)Total
Mean27.2 (22 to 41)33.3 (25 to 46)29.8 (22 to 43)37.2 (26 to 48)31.5 (29 to 34)28.6 (21 to 43)31.3 (21 to 48)
Sex: Female, Male
Sex: Female, Male(Participants)Group 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)Total
Female98891944
Male24431317
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Group 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)Total
Hispanic or Latino1011047
Not Hispanic or Latino101211112854
Unknown or Not Reported0000000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group 1: 0.6 mg HTNV - Intradermal (ID)Group 2: 3.0 mg HTNV - Intramuscular (IM)Group 3: 0.6 mg PUUV - Intradermal (ID)Group 4: 3.0 mg PUUV - Intramuscular (IM)Group 5: 1.2 mg HTNV/PUUV (0.6 mg Each) - Intradermal (ID)Group 6: 6.0 mg HTNV/PUUV (3.0 mg Each) - Intramuscular (IM)Total
African American35260319
Asian1020014
White66862735
Others1100002
Unknown0000011
08

Study locations

1 site
  • University of Maryland
    Baltimore, Maryland 21201, United States
09

References and documents

Study documents

  • Study protocol · Mar 2, 2022
  • Statistical analysis plan · Jan 25, 2019
  • Informed consent form · Feb 15, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03718130
Lead sponsor
U.S. Army Medical Research and Development Command
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), The Geneva Foundation, US Army Medical Research Institute of Infectious Diseases, Ichor Medical Systems Incorporated
Responsible party
Sponsor
First posted
Oct 24, 2018
Start date
Jul 10, 2019
Primary completion
Oct 7, 2022
Completion
Oct 7, 2022
Results posted
Jun 26, 2025
Last update
Jun 26, 2025

Study contacts

Kirsten E Lyke, MD
principal investigator · University of Maryland

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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