COVID-19 VaccinesPhase 1NCT05226390
Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate
A Phase 1 study testing MVA-SARS-2-ST in people with COVID-19 Vaccines, run by Hannover Medical School at 1 site in Germany.
Trial summary
This will be a phase I, single-center trial, including a total of 30 participants in two cohorts. Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccines
- What is being tested?
- MVA-SARS-2-ST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteGermany
- Study dates
- 24 Feb 2022to 17 Nov 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The subject must not be enrolled before all inclusion criteria (including test results) are confirmed. Subjects meeting all of the criteria listed below will be included in the study.
- Signed written informed consent from subject prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Healthy men or women, aged ≥ 18 ≤ 60 at day of inclusion having received either
- primary immunization (cohort 1) with any regimen using any EU marketed SARS- CoV-2 vaccine or
- subsequently booster immunization (cohort 2) with any EU marketed mRNA vaccine
- at least 3 months prior to enrollment
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- Adults with SARS-CoV-2 specific IgG concentration between 10 RU/ml and 1200 RU/ml determined by Anti-SARS-CoV-2-QuantiVac-ELISA (IgG)
- Males or non-pregnant, non-lactating females of child-bearing potential with negative pregnancy test at screening who agree to comply with the applicable contraceptive requirements of the protocol (Section 3.4) from at least 14 days prior to vaccination and during the entire duration of the study.
- or
- Females without child-bearing potential defined as follows:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- hysterectomy or uterine agenesis or
- ≥ 50 years and in postmenopausal state > 1 year or
- < 50 years and in postmenopausal state > 1 year with serum FSH > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
- Normal pulmonary function: FEV1 predicted ≥ 80% and FEV1/FVC > 70%
- Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening
- Subject is capable of understanding the investigational nature, potential risks and benefits of the clinical trial
Who cannot join
- Subjects are excluded from the study if any of the following criteria are met at screening or on dosing day.
- Previous MVA or rMVA vaccination
- Known allergy to the components of the SARS-CoV-2 vaccine product as chicken proteins or history of life-threatening reactions to vaccine containing the same substances
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance; safety laboratory screening evaluation can be repeated a maximum of two times
- Any finding in the medical history and physical examination deviating from normal and assessed as clinically relevant by the investigator
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- Evidence in the subject's medical history or in the medical examination that might influence the absorption, distribution, metabolism or excretion of the investigational medicinal product
- Current smoking/ vaping or smoking /vaping in the previous year.
- Clinically relevant findings in ECG
- Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic therapy in the previous 5 years, and/or diabetes
- Asthma, chronic obstructive pulmonary disease or other lung disease
- Respiratory tract infection in the 4 weeks prior to study treatment
- Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding a single febrile seizure as a child
- Known intolerance to medication used during bronchoscopy, i.e. midazolam and lidocaine.
- Treatment with ß-adrenoceptor antagonists
- Alcohol abuse (consumption of more than 20 g per day for females and 30 g per day for males)
- Drug abuse or positive drug screening
- Any positive result for HIV1/2, HCV antibody or HBs antigen testing
- Moderate or severe illness and/or fever >38 °C within 1 week prior to vaccination
- History of blood donation within 60 days of enrollment or plans to donate within the treatment phase
- Participation in a clinical trial or use of an investigational product within 30 days or five times the half-life of the investigational product -whichever is longer- prior to receiving the first dose within this study
- Investigator or employee of the study site or Sponsor with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, natural or adopted child) of the investigator or employee with direct involvement in the proposed study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School ZKS - Early Clinical Trial Unit at CRC Hannover
Hanover, 30625
About this study
Official title: Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults - Phase I Study
This will be a phase I, single-center trial, including a total of 30 participants in two cohorts.
Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen.
Read more
Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine
Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST
- Conditions
- COVID-19 Vaccines
- Being tested
- MVA-SARS-2-ST
- Keywords
- MVA-SARS-COV-2, MVA-SARS-2-ST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-SARS-2-STBiological
In this trial MVA-SARS-2-ST will be used. Each vial contains 1 x 107 IU/dose MVA-SARS-2-ST in 0.5 mL as active ingredient. The solution will be used for nebulization and direct administration to the respiratory tract.
| Study group | Role | What they receive |
|---|---|---|
| 1 x 107 IU/dose MVA-SARS-2-ST | Experimental | All Participants will receive a single booster dose of 1 x 107 IU MVA-SARS-2-ST in 0.5 mL as inhalation (total inhaled volume 0.5 mL) Receives: Biological: MVA-SARS-2-ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 0
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 1
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 2
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 3
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 4
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 5
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 6
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Occurrence of solicited local reactogenicity signs and symptoms
Measured: day 7
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as forced vital capacity (FVC) (%)
Measured: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as forced expiratory volume in 1 second (FEV1) (%)
Measured: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by spirometry as FEV1/FVC (%)
Measured: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently
Measured: day 0 and twice daily on days 1, 2, 3, 4, 5, 6, 7
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 0
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 1
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 2
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 3
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 4
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 5
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 6
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Measured: day 7
Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST
Occurrence of unsolicited adverse events (AE)
Measured: from day 0 to day 28 after vaccination
Change of safety laboratory measures associated with MVA-SARS-2-S
Change from baseline of safety laboratory measures
Measured: day 1, 3, 7, 14, 28, 56, 140
Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST
Occurrence of serious adverse events (SAE)
Measured: through study completion, an average of 5 month
Secondary outcomes (2)
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in blood
Measured: day 7, 14, 28, 56 and 140
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Change from baseline of levels of binding antibodies against SARS-CoV-2 spike S1 protein measured by ELISA in (bronchial alveolar lavage) BAL on day 14
Measured: day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start24 Feb 2022
- Primary completion17 Nov 2023
- Study completion17 Nov 2023
Why it stopped: cohort could not be recruited
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccinesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research, IDT Biologika, Universitätsklinikum Hamburg-Eppendorf
- Responsible party
- Sponsor
- Investigators
- Jens Hohlfeld, Prof., Principal investigator, Hannover Medical School, Department of Respiratory Medicine and Fraunhofer ITEM, Division of Clinical Airway ResearchReinhold Förster, Prof., Study chair, Hannover Medical School Institute of Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05226390
- Sponsor's protocol ID
- MVA-S2-S-R01
- Status last verified
- Jan 2024
- First submitted
- 31 Jan 2022
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Reactogenicity and Immunogenicity of a Novel MVA-SARS-2-ST Vaccine Candidate Administered as Inhalation Boost in SARS-CoV-2 Immunized Adults - Phase I Study
- ClinicalTrials.gov ID
- NCT05226390
- Acronym / sponsor ID
- MVA-S2-S-R01
- Conditions
- COVID-19 Vaccines
- Keywords
- MVA-SARS-COV-2, MVA-SARS-2-ST
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: cohort could not be recruited
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Center for Infection Research, IDT Biologika, Universitätsklinikum Hamburg-Eppendorf
- Study start
- 24 Feb 2022 (actual)
- Primary completion
- 17 Nov 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 7 Feb 2022 (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.
This will be a phase I, single-center trial, including a total of 30 participants in two cohorts.
Cohort 1 (n=6): Healthy male or female adults aged 18 - ≤ 60 previously primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen.
Cohort 2 (n=24): Healthy male or female adults aged 18 - ≤ 60 primary immunized with two vaccinations with any regimen using any EU marketed SARS-CoV-2 vaccine (mRNA-, vector-, protein-based, attenuated SARS-CoV-2 virus) or with a single application of COVID-19 Vaccine Janssen and subsequently booster immunized with any EU marketed mRNA vaccine
Both cohorts will be assigned to inhaled vaccination with MVA-SARS-2-ST
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 x 107 IU/dose MVA-SARS-2-ST | Experimental | Biological: MVA-SARS-2-STAll Participants will receive a single booster dose of 1 x 107 IU MVA-SARS-2-ST in 0.5 mL as inhalation (total inhaled volume 0.5 mL) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (17 listed)
- The subject must not be enrolled before all inclusion criteria (including test results) are confirmed. Subjects meeting all of the criteria listed below will be included in the study.
- Signed written informed consent from subject prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- Healthy men or women, aged ≥ 18 ≤ 60 at day of inclusion having received either
- at least 3 months prior to enrollment
- Adults with SARS-CoV-2 specific IgG concentration between 10 RU/ml and 1200 RU/ml determined by Anti-SARS-CoV-2-QuantiVac-ELISA (IgG)
Key exclusion criteria (22 listed)
- Subjects are excluded from the study if any of the following criteria are met at screening or on dosing day.
- Previous MVA or rMVA vaccination
- Known allergy to the components of the SARS-CoV-2 vaccine product as chicken proteins or history of life-threatening reactions to vaccine containing the same substances
- Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the trial vaccine
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance; safety laboratory screening evaluation can be repeated a maximum of two times
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 |
|---|---|---|
| MVA-SARS-2-STIn this trial MVA-SARS-2-ST will be used. Each vial contains 1 x 107 IU/dose MVA-SARS-2-ST in 0.5 mL as active ingredient. The solution will be used for nebulization and direct administration to the respiratory tract. | Biological | 1 x 107 IU/dose MVA-SARS-2-ST |
Primary outcome
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 0
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 1
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 2
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 3
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 4
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 5
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 6
Occurrence of solicited local reactogenicity signs and symptoms
The nature, frequency and severity of adverse events associated with MVA-SARS-2-ST
Time frame: day 7
Occurrence of solicited local reactogenicity signs and symptoms
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function measured by spirometry as forced vital capacity (FVC) (%)
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function measured by spirometry as forced expiratory volume in 1 second (FEV1) (%)
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Time frame: day 0 (2h), day 1, 3, 7, 14, 28, 56, 140
Change from baseline of pulmonary function measured by spirometry as FEV1/FVC (%)
Change from baseline of pulmonary function associated with MVA-SARS-2-ST
Time frame: day 0 and twice daily on days 1, 2, 3, 4, 5, 6, 7
Change from baseline of pulmonary function measured by peak flow as peak expiratory flow (PEF) frequently
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 0
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 1
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 2
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 3
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 4
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 5
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 6
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of solicited systemic reactogenicity signs and symptoms associated with MVA-SARS-2-ST
Time frame: day 7
Occurrence of solicited systemic reactogenicity signs and symptoms vaccination
Occurrence of unsolicited adverse events (AE) associated with MVA-SARS-2-ST
Time frame: from day 0 to day 28 after vaccination
Occurrence of unsolicited adverse events (AE)
Change of safety laboratory measures associated with MVA-SARS-2-S
Time frame: day 1, 3, 7, 14, 28, 56, 140
Change from baseline of safety laboratory measures
Occurrence of serious adverse events (SAE) associated with MVA-SARS-2-ST
Time frame: through study completion, an average of 5 month
Occurrence of serious adverse events (SAE)
2 secondary outcomes
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Time frame: day 7, 14, 28, 56 and 140
To evaluate immunogenicity of the candidate MVA-SARS-2-ST
Time frame: day 14
Results and safety
The study was stopped early (reason given: cohort could not be recruited). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jens Hohlfeld, Prof. principal investigator
Hannover Medical School, Department of Respiratory Medicine and Fraunhofer ITEM, Division of Clinical Airway Research
Reinhold Förster, Prof. study chair
Hannover Medical School Institute of Immunology
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 MVA-SARS-2-ST in people with COVID-19 Vaccines, run by Hannover Medical School at 1 site in Germany.
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 17 inclusion and 22 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: stopped early, as of the sponsor's last update on 21 Aug 2026. 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 Germany. 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 was stopped early (reason given: cohort could not be recruited). Results are not available in the source record.
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 nature, frequency and severity of adverse events associated with MVA-SARS-2-ST (time frame: day 0). The study lists 23 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 21 Aug 2026.