Hantaan VirusPhase 1NCT02776761
A Single-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Hantaan Puumala Virus DNA Vaccine
A Phase 1 study testing Hantaan Vaccine:, Puumala Vaccine and Hantaan/Puumala Vaccine in people with Hantaan Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hantaan Virus
- What is being tested?
- Hantaan Vaccine:, Puumala Vaccine and Hantaan/Puumala Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2016to 27 Sep 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
WRAIR Clinical Trials Center
Silver Spring, Maryland, 20910
About this study
Official title: 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.
Read the 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.
- Conditions
- Hantaan Virus
- Being tested
- Hantaan Vaccine:, Puumala Vaccine, Hantaan/Puumala Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hantaan Vaccine:Biological
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
Puumala VaccineBiological
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
Hantaan/Puumala VaccineBiological
DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
| Study group | Role | What they receive |
|---|---|---|
| Hantaan Vaccine: | Experimental | 1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose) Receives: Biological: Hantaan Vaccine: |
| Puumala Vaccine: | Experimental | 1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose) Receives: Biological: Puumala Vaccine |
| Hantaan/Puumala Vaccine | Experimental | 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) Receives: Biological: Hantaan/Puumala Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hantaan Vaccine: Number of Adverse Events
Number of adverse events.
Measured: 365 days
Puumala Vaccine: Number of Adverse Events
Number of adverse events.
Measured: 365 days
Hantaan/Puumala Vaccine: Number of Adverse Events
Number of adverse events.
Measured: 365 days
Secondary outcomes (9)
Hantaan Vaccine (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Measured: 365 days
Puumala Vaccine (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Measured: 365 days
Hantaan/Puumala Vaccin (50) immunogenicity
Pseudovirion neutralization assay 50% titer
Measured: 365 days
Hantaan Vaccine (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Measured: 365 days
Puumala Vaccine (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Measured: 365 days
Hantaan/Puumala Vaccin (80) immunogenicity
Pseudovirion neutralization assay 80% titer
Measured: 365 days
Hantaan Vaccine (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Measured: 84 days
Puumala Vaccine (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Measured: 84 days
Hantaan/Puumala Vaccin (80) immunogenicity
Plaque-reduction neutralization test (PRNT) comparing Day 0 to Day 84
Measured: 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study start30 Aug 2016
- Primary completion27 Sep 2017
- Study completion27 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantaan VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study will enroll 3 randomized groups of 9 subjects for a total of 27 subjects. Every subject will receive a total of 3 vaccinations. Subjects will be blinded to the group they are randomized to. Each vaccination consists of 2 administrations of 1 mg (left/right deltoid) for a total of 2 mg/vaccination. Group 1 will be vaccinated with the HTNV vaccine, pWRG/HTN-M (co). Group 2 will be vaccinated with the PUUV vaccine, pWRG/PUU-M (s2). Group 3 will be vaccinated with a combined HTNV/PUUV vaccines. Each group will be vaccinated on Days 0, 28, and 56. An optional 4th vaccination on Day 168 with follow-up on Day 196. All doses will be administered with PharmaJet Stratis device. All subjects to be followed until at least 3 months post last vaccination with Day 252 the final study visit (a 12-month, optional follow-up visit may be requested approximately on Day 365). Subjects will complete postinjection memory aids for 7 days after each vaccination.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kristopher Paolino, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776761
- Sponsor's protocol ID
- S-15-40
- Other IDs
- WRAIR 2289
- Status last verified
- Feb 2021
- First submitted
- 13 May 2016
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.)
- ClinicalTrials.gov ID
- NCT02776761
- Acronym / sponsor ID
- S-15-40
- Conditions
- Hantaan Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 27 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 18 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Study will enroll 3 randomized groups of 9 subjects for a total of 27 subjects. Every subject will receive a total of 3 vaccinations. Subjects will be blinded to the group they are randomized to. Each vaccination consists of 2 administrations of 1 mg (left/right deltoid) for a total of 2 mg/vaccination. Group 1 will be vaccinated with the HTNV vaccine, pWRG/HTN-M (co). Group 2 will be vaccinated with the PUUV vaccine, pWRG/PUU-M (s2). Group 3 will be vaccinated with a combined HTNV/PUUV vaccines. Each group will be vaccinated on Days 0, 28, and 56. An optional 4th vaccination on Day 168 with follow-up on Day 196. All doses will be administered with PharmaJet Stratis device. All subjects to be followed until at least 3 months post last vaccination with Day 252 the final study visit (a 12-month, optional follow-up visit may be requested approximately on Day 365). Subjects will complete postinjection memory aids for 7 days after each vaccination.
| Arm | Type | Receives |
|---|---|---|
| Hantaan Vaccine: | Experimental | Biological: 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) |
| Puumala Vaccine: | Experimental | Biological: Puumala Vaccine1 mg in 0.5 mL per administration, 2 administrations per vaccination, total injected volume 1 mL per vaccination (for 2.0 mg dose) |
| Hantaan/Puumala Vaccine | Experimental | Biological: Hantaan/Puumala VaccineThe 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) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hantaan Vaccine:DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline | Biological | Hantaan Vaccine: |
| Puumala VaccineDNA Vaccine 2.0 mg/1 mL phosphate-buffered saline | Biological | Puumala Vaccine: |
| Hantaan/Puumala VaccineDNA Vaccine 2.0 mg/1 mL phosphate-buffered saline | Biological | Hantaan/Puumala Vaccine |
Primary outcome
Hantaan Vaccine: Number of Adverse Events
Time frame: 365 days
Number of adverse events.
Puumala Vaccine: Number of Adverse Events
Time frame: 365 days
Number of adverse events.
Hantaan/Puumala Vaccine: Number of Adverse Events
Time frame: 365 days
Number of adverse events.
9 secondary outcomes
Hantaan Vaccine (50) immunogenicity
Time frame: 365 days
Puumala Vaccine (50) immunogenicity
Time frame: 365 days
Hantaan/Puumala Vaccin (50) immunogenicity
Time frame: 365 days
Hantaan Vaccine (80) immunogenicity
Time frame: 365 days
Puumala Vaccine (80) immunogenicity
Time frame: 365 days
Hantaan/Puumala Vaccin (80) immunogenicity
Time frame: 365 days
Hantaan Vaccine (80) immunogenicity
Time frame: 84 days
Puumala Vaccine (80) immunogenicity
Time frame: 84 days
Hantaan/Puumala Vaccin (80) immunogenicity
Time frame: 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristopher Paolino, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hantaan Vaccine:, Puumala Vaccine and Hantaan/Puumala Vaccine in people with Hantaan Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hantaan Vaccine: Number of Adverse Events (time frame: 365 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2021.