Immune Deficiency DiseasePhase 1/2B-pVACNCT04954469
B-pVAC-SARS-CoV-2: Study to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency
A Phase 1/2 study testing CoVAC-1 in people with Immune Deficiency Disease, run by University Hospital Tuebingen at 3 sites in Germany.
Trial summary
The indication of this study is To evaluate the safety and immunogenicity of a SARSCoV- 2-derived multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults with congenital or acquired B-cell/antibody deficiency Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immune Deficiency Disease
- What is being tested?
- CoVAC-1
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesGermany
- Study dates
- 30 Jun 2021to 30 Apr 2023
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (≥18 years) male or non-pregnant, non-lactating female
- Primary antibody deficiency syndrome or Secondary antibody deficiency syndrome, defined by one of the following:
- IgG < 4 g/l
- Ongoing substitution of immunoglobline for hypogammaglobinemia
- Anti-CD20 antibody (monospecific) therapy for malignant disease:
- after combined Anti-CD20 antibody therapy with chemotherapy (e.g. fludarabin, cyclophosphamid, bendamustin, anthracycline, vincristin) or BTK-inhibitors or BCL2-inhibitors (within 1-6 months post therapy)
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- ongoing single agent Anti-CD20 antibody therapy
- Anti-CD20 antibody maintenance therapy
- Ability to understand and voluntarily sign an informed consent form
- Ability to adhere to the study visit schedule and other protocol requirements
- Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue until three months after vaccination. Furthermore, contraception must be carried on by patients receiving B-cell depleting therapies for the whole duration of the treatment.
- Postmenopausal or evidence of non-child-bearing status. For women of childbearing potential: negative urine or serum pregnancy test within 7 days prior to study treatment. Postmenopausal or evidence of nonchildbearing status is defined as:
- Amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments
- Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the postmenopausal range for women under 50
Who cannot join
- Pregnant or lactating females
- Participation in any clinical trial with intake of any nonregistered vaccine product
- Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint:
- Active infection
- Psychiatric disorders
- Known systemic anaphylaxis
Show all 22Show fewer
- Prior or current infection with SARS-CoV-2 as assessed by medical history and/or by throat/nose swab (PCR) or serologically documented immunization against SARSCoV- 2 (after infection or vaccination)
- Persisting symptoms developed after SARS-CoV-2 vaccination with an approved vaccine product at study inclusion
- History of Guillain-Barré syndrome
- HIV infection, chronic or active hepatitis B or C
- History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/haemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as child)
- Baseline laboratory CD4+ T cell count < 100 μl
- The following pre-existing medical conditions:
- Chronic liver failure defined as Child-Pugh Score ≥B
- Chronic renal failure defined as GFR <40 ml/min/1,73m2
- Serious pre-existing cardiovascular disease such as NYHA ≥ III
- Sickle cell anemia
- Patients presenting with any clinical, laboratory or radiological signs of tumor-progression
- Patient receiving active treatment with small molecules, including Tyrosine Kinases-Inhibitors (e.g. Ibrutinib), Proteosome-Inhibitors (e.g. Bortezomib), Bcl-2- Inhibitors (e.g. Venetoclax), Phosphoinositid-3-Kinase- Inhibors (e.g. Idelalisib)
- Known hypersensitivity to any of the components included in the CoVac-1 vaccine
- Pre-existing auto-immune disease except for Hashimoto thyroiditis and mild (not requiring immunosuppressive treatment) psoriasis
- Intention of receiving one dose of an already approved vaccine against SARS-CoV-2 before day 56
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Charité - Universitätsmedizin Berlin Medizinische Klinik m. S. Hämatologie, Onkologie und Tumorimmunologie Charité Campus Benjamin Franklin
Berlin, 12203
Krankenhaus Nordwest gGmbH Institut für Klinisch-Onkologische Forschung (IKF)
Frankfurt am Main, Frankfurt, 60488
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: B-pVAC-SARS-CoV-2: Phase I/II Multicenter Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency
The indication of this study is To evaluate the safety and immunogenicity of a SARSCoV- 2-derived multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults with congenital or acquired B-cell/antibody deficiency
Read the detailed description
Multicenter Phase I-II clinical trial
Phase I:
Part I: 14-patients will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). 28 days following vaccination of the
1th patient, there will be an interim analysis of safety and immunogenicity and a review by the data safety monitoring board (DSMB) before proceeding to Phase II Definition of sufficient immunogenicity after one dose of vaccination: T cell response to at least one CoVAC-1 vaccine peptide on day28 in ≥80% of study patients, with proven general ability to mount antigen-specific T cell responses (detection of T cell responses to EBV/CMV control peptides) assessed by Interferon gamma (IFN-γ) ELISpot.
- The time point (day28) for the assessment of CoVac-1 induced T cell responses was selected based on the results of the ongoing P-pVAC-SARS-CoV-2 study, where CoVac-1-induced SARS-CoV-2 T cell responses were observed in 100% of study subjects at day28.
- The threshold of 80% was introduced after considering recent findings about cancer patients with hematological malignancies (comprising patients with B cell or antibody deficiencies) vaccinated with BNT162b2. Here it was observed that only 50% of patients had a BNT162b2-induced T cell response, while this was achieved in 80% of the healthy donors. Thus, the threshold of 80% was chosen, with the aim of providing our study population an immunization comparable to the one achieved in the healthy population vaccinated with the approved vaccines. CoVac-1 induced T cell responses are defined as positive T cell response in Interferon gamm (IFN-γ) ELISPOT assay with spot count at least 2-fold higher than the baseline assay (Visit 1). T cell responses are considered to be positive when the mean spot count per well is at least 3-fold higher than the mean number of spots in the negative control wells (stimulated with a control peptide). Only patients with detectable T cell response to the viral peptide panel ex vivo or after in vitro T cell expansion, and thus general ability to mount an antigen-specific immune response will be considered for the evaluation of sufficient immune responses after one CoVac-1 vaccination. Part II (optional): If there is an insufficient immune response measured by Interferon gamma (IFN-γ) ELISpot in Part I of Phase I on day 28, an additional Part (Part II) of Phase I will start enrollment of 14 subjects receiving two open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on day1 and day42.
Phase II (after an amendment to the protocol):
40 subjects will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and, depending on the data collected in Phase I, a second vaccination on day42 if necessary.
- Conditions
- Immune Deficiency Disease
- Being tested
- CoVAC-1
- Medical subject headings
- Immune Deficiency Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoVAC-1Biological
Peptide vaccination should be started as soon as possible after the screening visit.
| Study group | Role | What they receive |
|---|---|---|
| CoVAC-1 Vaccine | Experimental | Peptide vaccination should be started as soon as possible after the screening visit. Or in case of two vaccinations: Peptide vaccination should be started as soon as possible after the screening visit (V1) and on day 42 (V5) Receives: Biological: CoVAC-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety-Vital Signs 1 (Body Temperature)
Body temperature will be measured [temperature in centigrade]
Measured: Day 28
Safety-Vital Signs 2 (Blood Pressure and Pulse)
blood pressure [mmHg] pulse [bpm]
Measured: Day 28
Safety-Eastern Cooperative Oncology Group (ECOG) Status
Scale 0-5, the lower the scale value, the better
Measured: Day 28
Safety-Hematology 1 (Hemoglobin)
hemoglobin (Hb). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.
Hemoglobin [g/dl ]
Measured: day 28
Safety-Hematology 2 (White Blood Cells)
white blood cells (WBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.
White Blood Cells [1/µl]
Measured: day 28
Safety-Hematology 3 (Platelet Count)
platelet count (PLT) . Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.
Platelet Count [1000/µl]
Measured: day 28
Safety-Hematology 4 (Red Blood Cells)
red blood cells (RBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing.
Red Blood Cells [Mio/µl]
Measured: day 28
T cell response
Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit.
IFN-gamma ELISPOT Counts
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start30 Jun 2021
- Primary completion18 Aug 2022
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune Deficiency DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Phase I: Part I: 14 patients not infected with SARS-CoV-2 will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVAC-1). Part II (optional): If there is an insufficient immune response measured by IFN-γ ELISpot in Part I of Phase I on day 28, an additional Part (Part II) of Phase I will start enrollment of 14 subjects receiving two open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and d42. Phase II (after an amendment to the protocol): 40 subjects will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and, depending on the data collected in Phase I, a econd vaccination on d42 if necessary.
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helmut Salih, Prof. MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954469
- Sponsor's protocol ID
- B-pVAC-SARS-CoV-2
- Acronym
- B-pVAC
- Status last verified
- Nov 2022
- First submitted
- 5 Jul 2021
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heitmann JS, Tandler C, Marconato M, Nelde A, Habibzada T, Rittig SM, Tegeler CM, Maringer Y, Jaeger SU, Denk M, Richter M, Oezbek MT, Wiesmuller KH, Bauer J, Rieth J, Wacker M, Schroeder SM, Hoenisch Gravel N, Scheid J, Marklin M, Henrich A, Klimovich B, Clar KL, Lutz M, Holzmayer S, Horber S, Peter A, Meisner C, Fischer I, Loffler MW, Peuker CA, Habringer S, Goetze TO, Jager E, Rammensee HG, Salih HR, Walz JS. Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency. Nat Commun. 2023 Aug 18;14(1):5032. doi: 10.1038/s41467-023-40758-0.
PubMed 37596280
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- B-pVAC-SARS-CoV-2: Phase I/II Multicenter Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults With Bcell/ Antibody Deficiency
- ClinicalTrials.gov ID
- NCT04954469
- Acronym / sponsor ID
- B-pVAC / B-pVAC-SARS-CoV-2
- Conditions
- Immune Deficiency Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 8 Jul 2021 (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.
The indication of this study is To evaluate the safety and immunogenicity of a SARSCoV- 2-derived multi-peptide vaccine in combination with the TLR1/2 ligand XS15 in adults with congenital or acquired B-cell/antibody deficiency
Detailed description
Multicenter Phase I-II clinical trial
Phase I:
Part I: 14-patients will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1). 28 days following vaccination of the
1th patient, there will be an interim analysis of safety and immunogenicity and a review by the data safety monitoring board (DSMB) before proceeding to Phase II Definition of sufficient immunogenicity after one dose of vaccination: T cell response to at least one CoVAC-1 vaccine peptide on day28 in ≥80% of study patients, with proven general ability to mount antigen-specific T cell responses (detection of T cell responses to EBV/CMV control peptides) assessed by Interferon gamma (IFN-γ) ELISpot.
- The time point (day28) for the assessment of CoVac-1 induced T cell responses was selected based on the results of the ongoing P-pVAC-SARS-CoV-2 study, where CoVac-1-induced SARS-CoV-2 T cell responses were observed in 100% of study subjects at day28.
- The threshold of 80% was introduced after considering recent findings about cancer patients with hematological malignancies (comprising patients with B cell or antibody deficiencies) vaccinated with BNT162b2. Here it was observed that only 50% of patients had a BNT162b2-induced T cell response, while this was achieved in 80% of the healthy donors. Thus, the threshold of 80% was chosen, with the aim of providing our study population an immunization comparable to the one achieved in the healthy population vaccinated with the approved vaccines. CoVac-1 induced T cell responses are defined as positive T cell response in Interferon gamm (IFN-γ) ELISPOT assay with spot count at least 2-fold higher than the baseline assay (Visit 1). T cell responses are considered to be positive when the mean spot count per well is at least 3-fold higher than the mean number of spots in the negative control wells (stimulated with a control peptide). Only patients with detectable T cell response to the viral peptide panel ex vivo or after in vitro T cell expansion, and thus general ability to mount an antigen-specific immune response will be considered for the evaluation of sufficient immune responses after one CoVac-1 vaccination. Part II (optional): If there is an insufficient immune response measured by Interferon gamma (IFN-γ) ELISpot in Part I of Phase I on day 28, an additional Part (Part II) of Phase I will start enrollment of 14 subjects receiving two open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on day1 and day42.
Phase II (after an amendment to the protocol):
40 subjects will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and, depending on the data collected in Phase I, a second vaccination on day42 if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Phase I: Part I: 14 patients not infected with SARS-CoV-2 will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVAC-1). Part II (optional): If there is an insufficient immune response measured by IFN-γ ELISpot in Part I of Phase I on day 28, an additional Part (Part II) of Phase I will start enrollment of 14 subjects receiving two open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and d42. Phase II (after an amendment to the protocol): 40 subjects will receive an open-label 500 μl subcutaneous injection via needle and syringe of the study IMP (CoVac-1) on d1 and, depending on the data collected in Phase I, a econd vaccination on d42 if necessary.
| Arm | Type | Receives |
|---|---|---|
| CoVAC-1 Vaccine | Experimental | Biological: CoVAC-1Peptide vaccination should be started as soon as possible after the screening visit. Or in case of two vaccinations: Peptide vaccination should be started as soon as possible after the screening visit (V1) and on day 42 (V5) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Adult (≥18 years) male or non-pregnant, non-lactating female
- Primary antibody deficiency syndrome or Secondary antibody deficiency syndrome, defined by one of the following:
- Ability to understand and voluntarily sign an informed consent form
- Ability to adhere to the study visit schedule and other protocol requirements
- Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method) of contraception. This should be started from the signing of the informed consent and continue until three months after vaccination. Furthermore, contraception must be carried on by patients receiving B-cell depleting therapies for the whole duration of the treatment.
Key exclusion criteria (22 listed)
- Pregnant or lactating females
- Participation in any clinical trial with intake of any nonregistered vaccine product
- Any concomitant disease affecting the effect of the therapeutic vaccine or interfering with the study primary endpoint:
- Prior or current infection with SARS-CoV-2 as assessed by medical history and/or by throat/nose swab (PCR) or serologically documented immunization against SARSCoV- 2 (after infection or vaccination)
- Persisting symptoms developed after SARS-CoV-2 vaccination with an approved vaccine product at study inclusion
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 |
|---|---|---|
| CoVAC-1Peptide vaccination should be started as soon as possible after the screening visit. | Biological | CoVAC-1 Vaccine |
Primary outcome
Safety-Vital Signs 1 (Body Temperature)
Time frame: Day 28
Body temperature will be measured [temperature in centigrade]
Safety-Vital Signs 2 (Blood Pressure and Pulse)
Time frame: Day 28
blood pressure [mmHg] pulse [bpm]
Safety-Eastern Cooperative Oncology Group (ECOG) Status
Time frame: Day 28
Scale 0-5, the lower the scale value, the better
Safety-Hematology 1 (Hemoglobin)
Time frame: day 28
hemoglobin (Hb). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Hemoglobin [g/dl ]
Safety-Hematology 2 (White Blood Cells)
Time frame: day 28
white blood cells (WBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. White Blood Cells [1/µl]
Safety-Hematology 3 (Platelet Count)
Time frame: day 28
platelet count (PLT) . Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Platelet Count [1000/µl]
Safety-Hematology 4 (Red Blood Cells)
Time frame: day 28
red blood cells (RBC). Differential cell counts should be performed at baseline, at each visit during vaccination phase and thereafter at investigators discretion. Clinical status and laboratory parameters are to be followed using individual institutional guidelines and the best clinical judgment of the responsible physician, which can involve more frequent testing. Red Blood Cells [Mio/µl]
T cell response
Time frame: Day 28
Blood will be taken before peptide vaccination on V1, and during vaccination phase and follow-up at each visit. IFN-gamma ELISPOT Counts
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 4 Aug 2023.
- Derived from this study: PubMed 37596280Heitmann JS, Tandler C, Marconato M, Nelde A, Habibzada T, Rittig SM, Tegeler CM, Maringer Y, Jaeger SU, Denk M, Richter M, Oezbek MT, Wiesmuller KH, Bauer J, Rieth J, Wacker M, Schroeder SM, Hoenisch Gravel N, Scheid J, Marklin M, Henrich A, Klimovich B, Clar KL, Lutz M, Holzmayer S, Horber S, Peter A, Meisner C, Fischer I, Loffler MW, Peuker CA, Habringer S, Goetze TO, Jager E, Rammensee HG, Salih HR, Walz JS. Phase I/II trial of a peptide-based COVID-19 T-cell activator in patients with B-cell deficiency. Nat Commun. 2023 Aug 18;14(1):5032. doi: 10.1038/s41467-023-40758-0.
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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.
Helmut Salih, Prof. MD principal investigator
University Hospital Tuebingen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CoVAC-1 in people with Immune Deficiency Disease, run by University Hospital Tuebingen at 3 sites 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 14 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: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
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?
Safety-Vital Signs 1 (Body Temperature) (time frame: Day 28). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04954469, which also lists 1 linked publication.
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 4 Aug 2023.