TuberculosisPhase 1NCT03912207
Investigating Immune Responses to Aerosol BCG Challenge in Healthy UK Adults
A Phase 1 study testing BCG Danish in people with Tuberculosis, run by University of Oxford at 2 sites in United Kingdom.
Trial summary
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- BCG Danish
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Apr 2019to Jun 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adult aged 18-50 years
- Resident in or near Oxford for the duration of the study period
- Screening IGRA negative
- No relevant findings in medical history or on physical examination
- Allow the Investigators to discuss the individual's medical history with their GP
- Use effective contraception (see below) for the duration of the study period (people of child bearing potential only)
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- Refrain from blood donation during the study
- Give written informed consent
- Allow the Investigator to register volunteer details with a confidential database (The Over-volunteering Protection Service) to prevent concurrent entry into clinical studies/trials
- Willing to be tested for evidence of SARS-CoV-2 infection, if indicated and to allow public health notification of results if required.
- Able and willing (in the Investigator's opinion) to comply with all the study requirements
- For Group 8 only- previously vaccinated with BCG (at least 12 months prior to enrolment, as evidenced by a visible scar or documentation in medical or occupational health records)
Who cannot join
- Previously resident for more than 12 months concurrently in a rural area of a tropical climate where significant non-tuberculous mycobacterial exposure is likely
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior vaccination with BCG (G1-7 only) or any other candidate TB vaccine (all groups).
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study challenge date
- Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
- Concurrent oral, inhaled or systemic steroid medication or the concurrent use of other immunosuppressive agents
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- Shares a household with someone with clinically significant immunodeficiency (either from infection or medication) who is deemed to be at risk of developing disseminated BCG infection if exposed to BCG
- History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study agent, essential study procedures, sedative drugs, or any local or general anaesthetic agents
- Pregnancy, lactation or intention to become pregnant during study period
- Any clinically significant respiratory disease, including asthma
- Current smoker (defined as any smoking including e-cigarettes in the last 3 months)
- Clinically significant abnormality on screening chest radiograph
- Clinically significant abnormality of pulmonary function
- Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy
- Current use of any medication taken through the nasal or inhaled route including cocaine or other recreational drugs
- Clinical, radiological, or laboratory evidence of current active TB disease
- Past treatment for TB disease
- Any clinically significant abnormality of screening blood or urine tests
- Positive HBsAg, HCV or HIV antibodies
- Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
- People of Child Bearing Potential (POCBP) are required to use an effective form of contraception during the course of the study.
- Acceptable forms of contraception for POCBP volunteers include:
- Established use of oral, injected on implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Permanent sterilisation or bilateral tubal occlusion
- Barrier methods of contraception (condom; or occlusive cap with spermicide)
- Male sterilisation, if the vasectomised partner is the sole partner for the subject
- True abstinence, when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence and withdrawal are not acceptable methods of contraception)
- Exclusive same sex intercourse
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital
Oxford, Oxfordshire, OX3 7LE
Oxford University Hospitals- John Warin Ward, University of Oxford
Oxford, Oxfordshire, OX3 7LE
About this study
Official title: A Human Challenge Study to Evaluate Innate and Adaptive Immune Responses to a Controlled Human Infection With BCG Administered by the Intradermal or Aerosol Inhaled Route in Healthy, BCG-naïve or Historically BCG-vaccinated, UK Adult Volunteers
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge.
Read the detailed description
Mycobacterium tuberculosis (M.tb) is a pathogen with worldwide preponderance that infects humans and causes the transmissible disease tuberculosis (TB). An estimated one-third of the world's population is latently infected with M.tb, carrying a 10% lifetime risk of developing active life-threatening disease. In 2016, there were 10 million new cases worldwide and 1.7 million people died of TB. Co-infection with human immunodeficiency virus (HIV) greatly increases the risk of TB reactivation and death. Diagnosis is challenging and drug treatment is often harmful, costly and complex. For these reasons, it is essential to develop a more effective vaccine against TB.
An improved understanding of the nature of protective immunity in humans would significantly improve rational vaccine development. Whilst host immunity, particularly systemic adaptive immunity, has been well characterized in murine models, the understanding of the immunological events that occur in humans during acute infection is limited. In particular, the knowledge of human mucosal responses to M.tb. is limited. This is primarily due to the difficulties in studying early disease processes in the lung. Consequently, the majority of human studies have investigated immune responses ex-vivo in peripheral blood or after in-vitro infection of cell lines. A better understanding of the immune components that exist at the respiratory mucosal surfaces in humans could lead to interventions that prevent infection at the point of entry.
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge, allowing investigation into the immune components at mucosal surfaces.
- Conditions
- Tuberculosis
- Being tested
- BCG Danish, Saline placebo
- Keywords
- BCG, Aerosol, Tuberculosis, Challenge
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCG DanishBiological
BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
Saline placeboOther
Saline is a routinely used placebo.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, 2 Day Bronchoscopy | Experimental | Group 1: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 1 volunteers will have a bronchoscopy 2 days post challenge Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 2, 7 Day Bronchoscopy | Experimental | Group 2: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 2 volunteers will have a bronchoscopy 7 days post challenge Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 3, 14 Day Bronchoscopy | Experimental | Group 3: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG (Arm A) and 3 volunteers will receive aerosol inhaled normal saline placebo (Arm B). All Group 3 volunteers will have a bronchoscopy 14 days post challenge Volunteers in group 7 and group 3 (arm A) will be offered an optional follow up at 12 months, in order of enrolment until 10 such visits have been conducted. For group 3 volunteers this will be offered after unblinding. Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 4, 28 Day Bronchoscopy | Experimental | Group 4: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 4 volunteers will have a bronchoscopy 28 days post challenge Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 5, 56 Day Bronchoscopy | Experimental | Group 5: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 5 volunteers will have a bronchoscopy 56 days post challenge Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 6, Intradermal injection, 14 Day Bronchoscopy | Experimental | Group 6: 6 volunteers will receive 1 x 10^6 cfu intradermal injection BCG + aerosol saline and will have a bronchoscopy 14 days post challenge All volunteers in group 6 will be offered an optional follow up at 12 months Receives: Biological: BCG Danish; Other: Saline placebo |
| Group 7, 14 Day Bronchoscopy | Experimental | Group 7: 10 volunteers will receive 1 x 10^7cfu aerosol inhaled BCG. All Group 7 volunteers will have a bronchoscopy 14 days post challenge.
Volunteers in group 7 and group 3 (arm A) will be offered an optional follow up at 12 months, in order of enrolment until 10 such visits have been conducted Receives: Biological: BCG Danish |
| Group 8, Bronchoscopy Day 14 | Experimental | Group 8: 10 historically BCG vaccinated volunteers will receive aerosol inhaled BCG at a dose to be confirmed from emerging study data TB044 (Clinicaltrials.gov NCT04777721). All Group 8 volunteers will have a bronchoscopy 14 days post challenge. Receives: Biological: BCG Danish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of markers of innate immunity-cytokines
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically, cytokine levels will be measured by ELISpot and ELISA.
Measured: Up to day 168
Identification of markers of innate immunity-antigen presenting cells
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically, the activity of antigen presenting cells will be measured by flow cytometry
Measured: Up to day 168
Identification of markers of innate immunity-inflammation in tissue
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically IHC staining will be done to examine changes in tissue samples.
Measured: Up to day 168
Identification of markers of adaptive immunity-antibodies
Established markers of adaptive immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of adaptive response. Specifically, the presence of antibodies will be measured.
Measured: Up to day 168
Identification of markers of adaptive immunity-T cells
Established markers of adaptive immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of adaptive response. Specifically, T-cell activity will be determined by a flow cytometry panel.
Measured: Up to day 168
Secondary outcomes (1)
Mycobacterial growth inhibition assay
MGIA outcome on PBMCs collected at Day 56; readout in CFUs (colony forming units)
Measured: Up to day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start19 Apr 2019
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, University of Leicester
- Responsible party
- Sponsor
- Investigators
- Professor Helen McShane, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912207
- Sponsor's protocol ID
- TB043
- Status last verified
- Jan 2024
- First submitted
- 30 Jan 2019
- Last updated
- 3 Jan 2024
- Results posted
- No
- 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 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Challenge Study to Evaluate Innate and Adaptive Immune Responses to a Controlled Human Infection With BCG Administered by the Intradermal or Aerosol Inhaled Route in Healthy, BCG-naïve or Historically BCG-vaccinated, UK Adult Volunteers
- ClinicalTrials.gov ID
- NCT03912207
- Acronym / sponsor ID
- TB043
- Conditions
- Tuberculosis
- Keywords
- BCG, Aerosol, Tuberculosis, Challenge
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Wellcome Trust, National Institute for Health Research, United Kingdom, University of Leicester
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 11 Apr 2019 (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.
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge.
Detailed description
Mycobacterium tuberculosis (M.tb) is a pathogen with worldwide preponderance that infects humans and causes the transmissible disease tuberculosis (TB). An estimated one-third of the world's population is latently infected with M.tb, carrying a 10% lifetime risk of developing active life-threatening disease. In 2016, there were 10 million new cases worldwide and 1.7 million people died of TB. Co-infection with human immunodeficiency virus (HIV) greatly increases the risk of TB reactivation and death. Diagnosis is challenging and drug treatment is often harmful, costly and complex. For these reasons, it is essential to develop a more effective vaccine against TB.
An improved understanding of the nature of protective immunity in humans would significantly improve rational vaccine development. Whilst host immunity, particularly systemic adaptive immunity, has been well characterized in murine models, the understanding of the immunological events that occur in humans during acute infection is limited. In particular, the knowledge of human mucosal responses to M.tb. is limited. This is primarily due to the difficulties in studying early disease processes in the lung. Consequently, the majority of human studies have investigated immune responses ex-vivo in peripheral blood or after in-vitro infection of cell lines. A better understanding of the immune components that exist at the respiratory mucosal surfaces in humans could lead to interventions that prevent infection at the point of entry.
TB043 is a clinical challenge trial primarily to evaluate the safety of BCG challenge administered by the aerosol inhaled route in healthy, BCG naive (Group 1-7) as well as historically BCG vaccinated UK adults (Group 8) . The trial will also look to evaluate and compare the amount of BCG recovered from the lungs as various points after challenge, allowing investigation into the immune components at mucosal surfaces.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 1, 2 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 1: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 1 volunteers will have a bronchoscopy 2 days post challenge |
| Group 2, 7 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 2: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 2 volunteers will have a bronchoscopy 7 days post challenge |
| Group 3, 14 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 3: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG (Arm A) and 3 volunteers will receive aerosol inhaled normal saline placebo (Arm B). All Group 3 volunteers will have a bronchoscopy 14 days post challenge Volunteers in group 7 and group 3 (arm A) will be offered an optional follow up at 12 months, in order of enrolment until 10 such visits have been conducted. For group 3 volunteers this will be offered after unblinding. |
| Group 4, 28 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 4: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 4 volunteers will have a bronchoscopy 28 days post challenge |
| Group 5, 56 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 5: 10 volunteers will receive 1 x 10^7 cfu aerosol inhaled BCG and 3 volunteers will receive aerosol inhaled normal saline placebo. All Group 5 volunteers will have a bronchoscopy 56 days post challenge |
| Group 6, Intradermal injection, 14 Day Bronchoscopy | Experimental | Biological: BCG Danish, Other: Saline placeboGroup 6: 6 volunteers will receive 1 x 10^6 cfu intradermal injection BCG + aerosol saline and will have a bronchoscopy 14 days post challenge All volunteers in group 6 will be offered an optional follow up at 12 months |
| Group 7, 14 Day Bronchoscopy | Experimental | Biological: BCG DanishGroup 7: 10 volunteers will receive 1 x 10^7cfu aerosol inhaled BCG. All Group 7 volunteers will have a bronchoscopy 14 days post challenge. Volunteers in group 7 and group 3 (arm A) will be offered an optional follow up at 12 months, in order of enrolment until 10 such visits have been conducted |
| Group 8, Bronchoscopy Day 14 | Experimental | Biological: BCG DanishGroup 8: 10 historically BCG vaccinated volunteers will receive aerosol inhaled BCG at a dose to be confirmed from emerging study data TB044 (Clinicaltrials.gov NCT04777721). All Group 8 volunteers will have a bronchoscopy 14 days post challenge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adult aged 18-50 years
- Resident in or near Oxford for the duration of the study period
- Screening IGRA negative
- No relevant findings in medical history or on physical examination
- Allow the Investigators to discuss the individual's medical history with their GP
Key exclusion criteria (29 listed)
- Previously resident for more than 12 months concurrently in a rural area of a tropical climate where significant non-tuberculous mycobacterial exposure is likely
- Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period
- Prior vaccination with BCG (G1-7 only) or any other candidate TB vaccine (all groups).
- Administration of immunoglobulins and/or any blood products within the three months preceding the planned study challenge date
- Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
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 |
|---|---|---|
| BCG DanishBCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route. | Biological | Group 1, 2 Day Bronchoscopy, Group 2, 7 Day Bronchoscopy, Group 3, 14 Day Bronchoscopy, Group 4, 28 Day Bronchoscopy, Group 5, 56 Day Bronchoscopy, Group 6, Intradermal injection, 14 Day Bronchoscopy, Group 7, 14 Day Bronchoscopy, Group 8, Bronchoscopy Day 14 |
| Saline placeboSaline is a routinely used placebo. | Other | Group 1, 2 Day Bronchoscopy, Group 2, 7 Day Bronchoscopy, Group 3, 14 Day Bronchoscopy, Group 4, 28 Day Bronchoscopy, Group 5, 56 Day Bronchoscopy, Group 6, Intradermal injection, 14 Day Bronchoscopy |
Primary outcome
Identification of markers of innate immunity-cytokines
Time frame: Up to day 168
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically, cytokine levels will be measured by ELISpot and ELISA.
Identification of markers of innate immunity-antigen presenting cells
Time frame: Up to day 168
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically, the activity of antigen presenting cells will be measured by flow cytometry
Identification of markers of innate immunity-inflammation in tissue
Time frame: Up to day 168
Established markers of innate immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of innate response. Specifically IHC staining will be done to examine changes in tissue samples.
Identification of markers of adaptive immunity-antibodies
Time frame: Up to day 168
Established markers of adaptive immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of adaptive response. Specifically, the presence of antibodies will be measured.
Identification of markers of adaptive immunity-T cells
Time frame: Up to day 168
Established markers of adaptive immunity in blood, BAL and biopsy samples will be aggregated to determine overall characterisation of adaptive response. Specifically, T-cell activity will be determined by a flow cytometry panel.
1 secondary outcome
Mycobacterial growth inhibition assay
Time frame: Up to day 56
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- 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.
Professor Helen McShane principal investigator
University of Oxford
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BCG Danish in people with Tuberculosis, run by University of Oxford at 2 sites in United Kingdom.
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 12 inclusion and 29 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. 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 Kingdom. 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?
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?
Identification of markers of innate immunity-cytokines (time frame: Up to day 168). The study lists 5 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 3 Jan 2024.