Hantaan Virus NephropathyPhase 2NCT04333459
Safety/Immunogenicity Hantaan Virus DNA Vaccine and Puumala Virus DNA Vaccine, For Prevention of HFRS
A Phase 2 study testing Hantaan DNA Vaccine/Puumala DNA Vaccine in people with Hantaan Virus Nephropathy and Puumala Virus Nephropathy, run by U.S. Army Medical Research and Development Command at 2 sites in United States.
Trial summary
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. 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 Nephropathy, Puumala Virus Nephropathy
- What is being tested?
- Hantaan DNA Vaccine/Puumala DNA Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 23 Aug 2021to 15 Oct 2024
- Phase
- Phase 2
- 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
- Subjects must meet all of the following criteria to be included in the study:
- Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at the time of screening
- Have provided written informed consent before screening
- Completion of written test called the 'Assessment of Understanding' (minimum passing score of 80% with 2 attempts permitted).
- A subject must have a valid state or government-issued photo ID (eg, driver's license, military ID, or U.S. passport) \& be able to pass a background check in order to gain access to the base \& participate.
- In general, good health without clinically significant medical problems, as determined by pertinent medical history and clinical examination and laboratory assessments prior to entry into the study.
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- Available and able to participate for all study visits and procedures
- Females subjects must have had a hysterectomy or bilateral oopherectomy or must be using an effective method of contraception** from 30 days prior to the first study vaccination until 90 days after the last study vaccination.
- For this study, we define an effective contraceptive method as one that results in a failure rate of less than 1% per year when it is used consistently and correctly. This includes, but is not limited to, abstinence from sexual intercourse with a male partner, monogamous relationship with a vasectomized partner, bilateral tubal ligation, or intrauterine devices.
- Female subjects who have not had a hysterectomy or bilateral oopherectomy must have a negative serum pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to each study vaccination.
- Sexually active male participants whose partner is a woman who has not had a hysterectomy or bilateral oopherectomy and has not had a vasectomy** must agree not to father a child until 90 days after the last vaccination.
- performed > 1 year prior to screening
- Women agree to not donate eggs (ova, oocytes) and male subject agrees not to donate sperm from the start of screening onwards until at least 90 days after the last vaccination.
- Agree not to participate in another clinical trial during the study period.
- Agree not to donate blood to a blood bank for 3 months after receiving the last study vaccine.
- Have acceptable screening laboratory tests* within 90 days prior to enrollment. Refer to Appendix A for range of acceptable laboratory values. Screening laboratory values that are outside acceptable range but are thought to be due to an acute condition or due to laboratory error may be repeated once. [see Manual of Procedures (MOP)]
- Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing).
- Negative hepatitis B surface antigen (HBsAg) and hepatitis C antibody testing.
Who cannot join
- Subjects meeting any of the following criteria will be excluded from the study:
- History of previous hantavirus vaccine.
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- Ongoing participation in another clinical trial (those continuing through Day 337 will not join other new studies until their final visit)
- Receipt of licensed vaccines within 7 days before or after immunization (30 days for live vaccines)
- Any use of investigational drugs or vaccines within 30 days before starting the study.
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- 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, 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
- Have an acute illness*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination.
- An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol. Subjects may re-screen after an acute illness is resolved
- Any confirmed or suspected immunosuppressive or immunodeficient condition or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
- 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
- Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child and intermittent non migraine headaches
- Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other psychiatric diagnosis that may interfere with subject compliance or safety evaluations.
- Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others within 10 years prior to study vaccination.
- Suspected or known current alcohol or drug abuse that in the opinion of the investigator could impact subject safety, interpretation of adverse events or ability to follow up.
- Have any plan to have major surgery that, in the opinion of the investigator, could impact subject safety or interpretation of adverse events between enrollment and the end of the study.
- A diagnosis of Type I or II diabetes.
- Unwilling to allow storage and use of blood for future hantavirus-related research (for monoclonal antibody development, and crossreactivity to other hantaviruses).
- 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.
- Elimination Criteria:
- The following criteria will be assessed at enrollment and prior to each vaccination, to determine whether or not the subject will be eliminated from the "according to protocol" analysis. On the basis of these criteria the subject may be disqualified from further vaccination or from any other aspect of the clinical trial procedures as judged appropriate by study investigators. A subject meeting any of the following criteria will still be followed for safety, unless the subject chooses to have complete withdrawal of the consent for further participation in any trial procedures.
- Use of any investigational drug or vaccine other than the study vaccine(s) during the study period.
- Receipt of a licensed vaccine within 7 days prior to or 7 days after vaccination (30 days for live vaccines).
- Administration of chronic (defined as more than 14 days) immunosuppressive drugs (including oral steroids in doses that are the same as those listed in the exclusion criteria) or other immune modifying drugs.
- Administration of immunoglobulins and/or any blood products during the study period.
- Known intravenous drug abuse evident through subject history or on physical exam.
- Poor reliability, inability to keep appointments, or other protocol violation.
- Any other significant finding that in the opinion of the investigator would increase the risk of having an adverse outcome as a result of continued participation in this study.
- Investigators will eliminate a subject from the study prior to first vaccination if the subject is found to have met any exclusion criteria in the time leading up to vaccination.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Clinical Trials Center, Walter Reed Army Institute of Reserach
Silver Spring, Maryland, 20910
Department of Clinical Trials, WRAIR
Silver Spring, Maryland, 20910
About this study
Official title: Phase 2A, Randomized, Double-Blind Study in Healthy Adults Safety/Immunogenicity Of Hantaan Virus And Puumala Virus DNA Vaccines To Prevent Hemorrhagic Fever Renal Syndrome Using Pharmajet Stratis® Needle-Free Jet Injection Delivery Device
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
Read the detailed description
The study will enroll 4 randomized groups of 33 subjects each for a total of 132 subjects. Every subject will receive a total of 4 vaccinations. Subjects and study personnel will be blinded to the group that they are randomized to (double-blind). The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
For the 2 mg dose, each vaccination consists of 2 administrations of 1 mg (left and right deltoid) for a total of 2 mg/vaccination. For the 1 mg dose, each vaccination consists of 2 administrations of 0.5 mg (left and right deltoid) for a total of 1 mg/vaccination.
Group 1 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 2 mg/vaccination dose. Group 2 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 1 mg/vaccination dose. Group 3 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 2 mg/vaccination dose. Group 4 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 1 mg/vaccination dose. Each group will be vaccinated on Days 1, 29, 57 and 169. All doses will be administered with the PharmaJet Stratis device, which is FDA cleared for IM administration of vaccines. All subjects will be followed until 6 months (month defined as 28 days) after the last vaccination with Day 337 being the final study visit. Subjects will complete post-injection memory aids for 7 days after each vaccination.
- Being tested
- Hantaan DNA Vaccine/Puumala DNA Vaccine
- Medical subject headings
- Hemorrhagic Fever with Renal Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hantaan DNA Vaccine/Puumala DNA VaccineBiological
Vaccine compared in High and Low Doses.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - "High Dose" Hantaan | Active comparator | Group 1 will be vaccinated with the "High Dose" of HTNV DNA vaccine, 2 mg of pWRG/HTN-M(co) with 0.5 mg/each deltoid. Receives: Biological: Hantaan DNA Vaccine/Puumala DNA Vaccine |
| Group 2 - "Low Dose" Hantaan | Active comparator | Group 2 will be vaccinated with the "Low Dose" of HTNV DNA vaccine, 1 mg of pWRG/HTN-M(co) with 1.0 mg/each deltoid. Receives: Biological: Hantaan DNA Vaccine/Puumala DNA Vaccine |
| Group 3 - "High Dose" Puumala | Active comparator | Group 3 will be vaccinated with the "High Dose" of PUUV DNA vaccine, 2 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid. Receives: Biological: Hantaan DNA Vaccine/Puumala DNA Vaccine |
| Group 4 - "Low Dose" Puumala | Active comparator | Group 4 will be vaccinated with the "Low Dose" of PUUV DNA vaccine, 1 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid. Receives: Biological: Hantaan DNA Vaccine/Puumala DNA Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects in Group 1 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
To assess the proportion of subjects in the high dose HTNV vaccine group (Group 1) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device.
Measured: 197 (+/- 2) days
The proportion of subjects in Group 3 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers.
To assess the proportion of subjects in the high dose PUUV vaccine group (Group 3) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device
Measured: 197 (+/- 2) days
Secondary outcomes (2)
The proportion of subjects in Group 2 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
To assess the proportion of subjects in the low dose HTNV vaccine group (Group 2) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device. This secondary objective will be evaluated only if the corresponding High Dose Group primary objective shows significance
Measured: 197 (+/- 2) days
The proportion of subjects in Group 4 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
To assess the proportion of subjects in the low dose PUUVV vaccine group (Group 4) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device. This secondary objective will be evaluated only if the corresponding High Dose Group primary objective shows significance.
Measured: 197 (+/- 2) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start23 Aug 2021
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantaan Virus NephropathyStudies 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 2
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- U.S. Army Medical Research and Development Command
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Trevor Wellington, MD, Principal investigator, Walter Reed Army Institute of Research (WRAIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333459
- Sponsor's protocol ID
- S-19-06
- Status last verified
- May 2026
- First submitted
- 31 Mar 2020
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2A, Randomized, Double-Blind Study in Healthy Adults Safety/Immunogenicity Of Hantaan Virus And Puumala Virus DNA Vaccines To Prevent Hemorrhagic Fever Renal Syndrome Using Pharmajet Stratis® Needle-Free Jet Injection Delivery Device
- ClinicalTrials.gov ID
- NCT04333459
- Acronym / sponsor ID
- S-19-06
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- U.S. Army Medical Research and Development CommandUS federal agency
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 3 Apr 2020 (actual)
- 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.
A randomized 4 cohort study that is comparing the data collected during the earlier phase study and to determine if immunogenicity can be retained with a 1 mg dose of Hantaan DNA vaccine. The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
Detailed description
The study will enroll 4 randomized groups of 33 subjects each for a total of 132 subjects. Every subject will receive a total of 4 vaccinations. Subjects and study personnel will be blinded to the group that they are randomized to (double-blind). The study is intended to substantiate the Phase 1 results with the 2 mg dose and to also determine if immunogenicity can be retained with a 1 mg dose (for HTNV DNA vaccine).
For the 2 mg dose, each vaccination consists of 2 administrations of 1 mg (left and right deltoid) for a total of 2 mg/vaccination. For the 1 mg dose, each vaccination consists of 2 administrations of 0.5 mg (left and right deltoid) for a total of 1 mg/vaccination.
Group 1 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 2 mg/vaccination dose. Group 2 will be vaccinated with the HTNV DNA vaccine, pWRG/HTN-M(co) at the 1 mg/vaccination dose. Group 3 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 2 mg/vaccination dose. Group 4 will be vaccinated with the PUUV DNA vaccine, pWRG/PUU-M(s2) at the 1 mg/vaccination dose. Each group will be vaccinated on Days 1, 29, 57 and 169. All doses will be administered with the PharmaJet Stratis device, which is FDA cleared for IM administration of vaccines. All subjects will be followed until 6 months (month defined as 28 days) after the last vaccination with Day 337 being the final study visit. Subjects will complete post-injection memory aids for 7 days after each vaccination.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 - "High Dose" Hantaan | Active comparator | Biological: Hantaan DNA Vaccine/Puumala DNA VaccineGroup 1 will be vaccinated with the "High Dose" of HTNV DNA vaccine, 2 mg of pWRG/HTN-M(co) with 0.5 mg/each deltoid. |
| Group 2 - "Low Dose" Hantaan | Active comparator | Biological: Hantaan DNA Vaccine/Puumala DNA VaccineGroup 2 will be vaccinated with the "Low Dose" of HTNV DNA vaccine, 1 mg of pWRG/HTN-M(co) with 1.0 mg/each deltoid. |
| Group 3 - "High Dose" Puumala | Active comparator | Biological: Hantaan DNA Vaccine/Puumala DNA VaccineGroup 3 will be vaccinated with the "High Dose" of PUUV DNA vaccine, 2 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid. |
| Group 4 - "Low Dose" Puumala | Active comparator | Biological: Hantaan DNA Vaccine/Puumala DNA VaccineGroup 4 will be vaccinated with the "Low Dose" of PUUV DNA vaccine, 1 mg of pWRG/PUU-M(s2) with 1.0 mg/each deltoid. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy adult male or nonpregnant, nonlactating female, ages 18-49 (inclusive) at the time of screening
- Have provided written informed consent before screening
- Completion of written test called the 'Assessment of Understanding' (minimum passing score of 80% with 2 attempts permitted).
- A subject must have a valid state or government-issued photo ID (eg, driver's license, military ID, or U.S. passport) \& be able to pass a background check in order to gain access to the base \& participate.
- In general, good health without clinically significant medical problems, as determined by pertinent medical history and clinical examination and laboratory assessments prior to entry into the study.
Key exclusion criteria (36 listed)
- History of previous hantavirus vaccine.
- History of severe local or systemic reactions to any vaccination or a history of severe allergic reactions
- Ongoing participation in another clinical trial (those continuing through Day 337 will not join other new studies until their final visit)
- Receipt of licensed vaccines within 7 days before or after immunization (30 days for live vaccines)
- Any use of investigational drugs or vaccines within 30 days before starting the study.
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 DNA Vaccine/Puumala DNA VaccineVaccine compared in High and Low Doses. | Biological | Group 1 - "High Dose" Hantaan, Group 2 - "Low Dose" Hantaan, Group 3 - "High Dose" Puumala, Group 4 - "Low Dose" Puumala |
Primary outcome
The proportion of subjects in Group 1 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
Time frame: 197 (+/- 2) days
To assess the proportion of subjects in the high dose HTNV vaccine group (Group 1) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device.
The proportion of subjects in Group 3 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers.
Time frame: 197 (+/- 2) days
To assess the proportion of subjects in the high dose PUUV vaccine group (Group 3) that achieve immunologic seroconversion above the minimum target threshold of 80% seroconversion, after receiving 4 doses of vaccine using the PharmaJet Stratis ® device
2 secondary outcomes
The proportion of subjects in Group 2 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
Time frame: 197 (+/- 2) days
The proportion of subjects in Group 4 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers
Time frame: 197 (+/- 2) 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 19 May 2026.
- Individual participant dataSharing planned: Undecided
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.
Trevor Wellington, MD principal investigator
Walter Reed Army Institute of Research (WRAIR)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hantaan DNA Vaccine/Puumala DNA Vaccine in people with Hantaan Virus Nephropathy and Puumala Virus Nephropathy, run by U.S. Army Medical Research and Development Command at 2 sites 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 18 inclusion and 36 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 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The proportion of subjects in Group 1 that achieve seroconversion by Day 197, which is defined as a PsVNA50 titer >= 40 or at least a four-fold increase in baseline titers (time frame: 197 (+/- 2) days). The study lists 2 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 19 May 2026.