A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine

February 10, 2021 updated by: U.S. Army Medical Research and Development Command

Hantaan Virus Plasmid DNA Vaccine (Expressing Gn and Gc Antigens; E. Coli) [HTNV Vaccine] and Puumala Virus Plasmid DNA Vaccine (Expressing Gn and Gc Antigens; E. Coli; Ajinomoto Bio-Pharma Services) [PUUV Vaccine] Administered Via Stratus Needle-free Injection System (PharmaJet, Inc.)

This is a single-center, randomized, single-blinded study of the Hantaan virus HTNV DNA vaccine alone, Puumala virus PUUV DNA vaccine alone, and mixed Hantaan/Puumala HTNV/PUUV DNA vaccines delivered intramuscularly IM by the needle-free PharmaJet Stratus DSJI device.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Investigational HTNV and PUUV DNA vaccines, manufactured in accordance with cGMP guidelines by Ajinomoto Bio-Pharma Services (California), from their respective drug substances, pWRG/HTN-M(co) and pWRG/PUU-M(s2),were constructed on a well-characterized plasmid backbone, pWRG7077. These plasmid DNA vaccines will be delivered IM using the needle-free, disposable syringe jet injection device (PharmaJet Stratis). Subjects will be randomized into 3 groups of 9 subjects each for a total of 27 subjects. Each subject will receive a total of 3 vaccinations. Group 1 vaccine will consist of 2 administrations of 1 mg of HTN plasmid (left and right deltoid) for a total of 2 mg/vaccination. Group 2 vaccine will consist of 2 administrations of 1 mg of PUU plasmid (left, right deltoid) for a total of 2 mg/vaccination. Group 3 vaccine will consist of a 1:1 mixture of HTNM and PUU vaccines (left, right deltoid) for a total of 2 mg/vaccination (1 mg/vaccination of each DNA). Vaccinations will be administered on Days 0, 28, and 56. There will be an optional 4th vaccination on Day 168 dependent on subject availability for the additional follow-up visit on Day 196, tolerability of the vaccinations to date, and investigator discretion. Volunteers will be invited back for the 4th vaccination to determine if a booster dose results in increased immunogenicity and seroconversion. All subjects will be followed until Day 252 (9 months). A Day 365 follow-up visit, for an immunogenicity draw only, may be requested dependent on immunogenicity results shortly after this final date, generally within 4 weeks of the Day 252 visit or once the assays can be completed. Subjects may be allowed to receive other licensed vaccinations or enroll in other clinical trials after the Day 252 visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
27

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Silver Spring, Maryland, United States, 20910
        • WRAIR Clinical Trials Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 49 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adult male or nonpregnant, nonlactating 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 not abstinent, are known to be at least 1 year post-menopausal (defined as no menses for 12 consecutive months) or willing to use an effective method of contraception (eg, hormonal contraception to include oral and implantable options, diaphragm, cervical cap, intrauterine device, condom, or anatomical sterility [self or partner]) for the duration of study participation (from the date of screening) until at least 3 months after the last injection
  • Negative hantavirus PsVNA test result at screening

Exclusion Criteria:

  • History or serologic evidence of prior infection with any hantavirus or prior participation in an 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 (subjects continuing through Day 365 will not join other new studies until their final visit)
  • Receipt of licensed vaccines within 14 days before or after immunization (30 days for live vaccines)
  • 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, 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 Blood donation for human use (eg, American Red Cross or other similar blood drives) within the 56 days preceding study entry or planned administration during the study period
  • Any confirmed 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
  • For corticosteroids, this will mean prednisone, or equivalent, greater than or equal to 0.5 mg/kg/day
  • Intranasal, inhaled, and topical steroids are allowed (daily inhaled steroids for treatment of asthma are NOT allowed)
  • Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Hantaan Vaccine:
1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose)
Biological: Hantaan Vaccine:
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
EXPERIMENTAL: Puumala Vaccine:
1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose)
Biological: Puumala Vaccine
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
EXPERIMENTAL: Hantaan/Puumala Vaccine
The HTNV and PUUV vaccine will be combined (equal volumes) before use: 1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose)
Biological: Hantaan/Puumala Vaccine
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hantaan Vaccine: Number of Adverse Events
Time Frame: 365 days
Number of adverse events.
365 days
Puumala Vaccine: Number of Adverse Events
Time Frame: 365 days
Number of adverse events.
365 days
Hantaan/Puumala Vaccine: Number of Adverse Events
Time Frame: 365 days
Number of adverse events.
365 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hantaan Vaccine (50) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 50% titer
365 days
Puumala Vaccine (50) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 50% titer
365 days
Hantaan/Puumala Vaccin (50) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 50% titer
365 days
Hantaan Vaccine (80) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 80% titer
365 days
Puumala Vaccine (80) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 80% titer
365 days
Hantaan/Puumala Vaccin (80) immunogenicity
Time Frame: 365 days
Pseudovirion neutralization assay 80% titer
365 days
Hantaan Vaccine (80) immunogenicity
Time Frame: 84 days
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
84 days
Puumala Vaccine (80) immunogenicity
Time Frame: 84 days
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
84 days
Hantaan/Puumala Vaccin (80) immunogenicity
Time Frame: 84 days
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
84 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
U.S. Army Medical Research and Development Command

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Kristopher Paolino, MD, Walter Reed Army Institute of Research (WRAIR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 30, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 18, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 16, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S-15-40
  • WRAIR 2289 (OTHER: WRAIR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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