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Phase 2a Immunogenicity Study of Hantaan/Puumala Virus DNA Vaccine for Prevention of Hemorrhagic Fever

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by U.S. Army Medical Research and Materiel Command
Sponsor:
Collaborators:
Walter Reed Army Institute of Research (WRAIR)
Ichor Medical Systems Incorporated
United States Army Medical Materiel Development Activity
United States Army Medical Research Institute of Infectious Diseases
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT02116205
First received: April 14, 2014
Last updated: September 12, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to compare the immune responses of two different doses (1.0 mg and 2.0 mg) and two different dosing schedules (two doses or three doses) of a mixed Hantaan virus (HTNV) and Puumala virus (PUUV) DNA vaccine in healthy participants. To maintain a blind, participants in the two-dose group will receive one dose of normal saline placebo. All of the groups will also receive a booster dose 6 months after first vaccination. The results will help to determine which dose and vaccination schedule will be best to move forward in the vaccine development process.


Condition Intervention Phase
Hemorrhagic Fever With Renal Syndrome
Biological: HTNV/PUUV DNA vaccine
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 2a Randomized, Double-Blind, Dose-Optimizing Study to Evaluate the Immunogenicity of Hantaan/Puumala Virus DNA Vaccine Administered to Healthy Adult Volunteers Using the TDS-IM Electroporation Delivery Device for Prevention of Hemorrhagic Fever With Renal Syndrome

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Seroconversion rates of the HTNV/PUUV DNA vaccine [ Time Frame: Study Days 0 to 365 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Rate of adverse events (AEs) in study subjects [ Time Frame: Study Days 0 to 14, 28 to 42, 56 to 70 and 168 to 182 ] [ Designated as safety issue: Yes ]
    Solicited AEs occurring from the time of each injection through 14 days following the procedure, with the first 7 days following vaccination to be assisted with a memory aid.


Estimated Enrollment: 132
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  • Administration of chronic (defined as more than 14 days) immunosuppressants or other immune modifying drugs within 6 months of study entry

    1. For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
    2. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02116205

Contacts
Contact: Kristopher Paolino, MD 301-319-9072 kristopher.m.paolino.mil@mail.mil

Locations
United States, Maryland
Walter Reed Army Institute of Research Clinical Trials Center Recruiting
Silver Spring, Maryland, United States, 20910
Contact: Kristopher M Paolino, MD    301-319-9072    kristopher.m.paolino.mil@mail.mil   
Principal Investigator: Kristopher M Paolino, MD         
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Walter Reed Army Institute of Research (WRAIR)
Ichor Medical Systems Incorporated
United States Army Medical Materiel Development Activity
United States Army Medical Research Institute of Infectious Diseases
Investigators
Principal Investigator: Kristopher Paolino, MD WRAIR Clinical Trials Center
  More Information

No publications provided

Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT02116205     History of Changes
Other Study ID Numbers: S-14-01, 2085
Study First Received: April 14, 2014
Last Updated: September 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
Hantaan virus
Puumala virus
HFRS

Additional relevant MeSH terms:
Hemorrhagic Fever with Renal Syndrome
Hemorrhagic Fevers, Viral
Fever
Syndrome
Body Temperature Changes
Bunyaviridae Infections
Disease
Hantavirus Infections
Pathologic Processes
RNA Virus Infections
Signs and Symptoms
Virus Diseases

ClinicalTrials.gov processed this record on November 23, 2014