NCT01502345

Brief Summary

The purpose of this study is:

  • To assess safety and tolerability of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), administered intramuscularly using a TDS-IM electroporation device Secondary:
  • To evaluate clinical immunogenicity of the HTNV and PUUV DNA vaccines, pWRG/HTN-M(x) and pWRG/PUUV-M(s2), including an assessment of the acute procedure tolerability when administered with the TDS-IM electroporation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 23, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

December 23, 2011

Last Update Submit

January 30, 2013

Conditions

Hemorrhagic Fever With Renal Syndrome

Keywords

HFRS

Outcome Measures

Primary Outcomes (2)

  • Change from baseline for solicited adverse events after each vaccination

    • The nature, frequency, and severity of local and systemic AEs or SAEs associated with TDS-IM-EP-based administration of HTNV and PUUV vaccines

    Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14

  • Change from baseline for Unsolicited adverse events after each vaccination

    • The nature, frequency, and severity of local and systemic AEs or SAEs associated with TDS-IM-EP-based administration of HTNV and PUUV vaccines

    Day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24

Secondary Outcomes (1)

  • Change in neutralizing antibody levels from baseline to post vaccination

    Day 0, 28, 56, 84, 140, 180 and 240

Study Arms (3)

PUUV DNA Vaccine

EXPERIMENTAL

This group will receive Puumala Virus DNA Vaccine only

Biological: Vaccine/device combination for prevention of HFRS

HTNV + PUUV

EXPERIMENTAL

This group will receive a 1:1 mixture of HTNV and PUUV DNA Vaccines

Biological: Vaccine/device combination for prevention of HFRS

HTNV DNA Vaccine

EXPERIMENTAL

This group will receive Hantaan Virus DNA Vaccine only

Biological: Vaccine/device combination for prevention of HFRS

Interventions

Vaccine/device combination for prevention of HFRSBIOLOGICAL

PUUV DNA Vaccine, 2.0mg/ml TDS-IM injection HTNV DNA Vaccine, 2.0 mg/ml TDS-IM injection HTNV + PUUV Vaccine mixture, 1.0mg/mL + 1.0mg/ml TDS-IM injection

Also known as: Ichor Tri-Grid Delivery System, Hantavirus
HTNV + PUUVHTNV DNA VaccinePUUV DNA Vaccine

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adult male or non-pregnant, non-lactating 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 protocol information
  • Individuals who fail the comprehension assessment for the second time will not be enrolled
  • Have provided written informed consent before screening
  • Free of clinically significant health problems, as determined by pertinent medical history and clinical examination before entry into the study
  • Available and able to participate for all study visits and procedures
  • If sexually active, known to be at least 1 year post-menopausal, or willing to use an effective method of contraception (e.g., birth control pill, diaphragm, cervical cap, intrauterine device, condom, or anatomical sterility \[in self or partner\]) from the date of screening until at least 6 months after the last vaccination
  • Negative hantavirus IgG antibody test result at screening (ELISA)

You may not qualify if:

  • History or serologic evidence of prior infection with either HTNV or PUUV virus, or prior participation in a HTNV or PUUV virus vaccine trial
  • History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
  • Any serologic evidence of hepatitis B or C infection
  • Ongoing participation in another clinical trial
  • Receipt or planned receipt of any vaccination, experimental or otherwise, within the period 30 days prior to initial injection through 60 days after the Day 70 follow-up (approximately a 6 month period in total)
  • 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 injection 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, hepatic or renal functional abnormality as determined by the investigator based on medical history, physical examination, EKG, 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 confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection
  • 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
  • Inhaled and topical steroids are allowed
  • Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research

Silver Spring, Maryland, 20910, United States

Location

MeSH Terms

Conditions

Hemorrhagic Fever with Renal Syndrome

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Hantavirus InfectionsBunyaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsHemorrhagic Fevers, Viral

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • James E Moon, MD

    WRAIR, Clinical Trials Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2011

First Posted

December 30, 2011

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)