Acquired Immunodeficiency4CMenBNCT04295733
Safety, Tolerability and Immunogenicity of 4CMenB Vaccine(2 Doses) in Adults With an Immunodeficiency
An observational study of Acquired Immunodeficiency, run by Ospedale Policlinico San Martino at 1 site in Italy.
Trial summary
The meningococcal quadrivalent conjugate vaccine (MenACWY) and the licenced multicomponent MenB vaccine (Bexsero®) have already been included in the Italian childhood immunization programme and recommendations for high risk categories have been also implemented. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acquired Immunodeficiency
- What is being tested?
- 4CMenB (Bexsero®) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 98 participants
- Where
- 1 siteItaly
- Study dates
- 6 Feb 2020to 11 Jan 2024
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 18 to 65 years with an acquired immune deficiency, including three study groups: * Cohort l-Hematopoietic Stem Celi Transplant (HSCT) patients * Cohort 2-HIV infected subjects * Cohort 3-patients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab)
Who may be able to join
- Males and females 18 through 65 years of age at the time of enrollment who are high risk for IMD, including subjects with documented medical history of any of the following criteria:
- Hematopoietic Stem Celi Transplantation (allogenic or autologous stem celi transplant)
- HIV infection
- candidate for / in treatment (ongoing) with biological drugs such as monoclonal antibodies anti CD- 20 (rituximab or ocrelizumab)
- Written informed consent obtained from the subject (or legal representative).
- Subjects (or legal representative) who are able to comprehend all procedures and to comply with the study requirements
Who cannot join
- Subjects not able to understand and to adhere to ali study procedures
- Subjects aged <18 or >65 years
- Known or suspected allergy/hypersensitivity to any vaccine component
- History of serious adverse reaction to any vaccine
- Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the entire study period
- History of any meningococcal group B vaccination or having been diagnosed with meningococcal disease ever before
Show all 18Show fewer
- Stem celi transplantation within 6 months before the enrollment to the study
- HIV-infected patients with detectable viral load (>50 copies/mL) and/or CD4 celi count < 200 cells/mm3 in the last 6 months
- Receipt of any vaccine within 28 (for live vaccines) or 14 (for no-live vaccines) days prior to study vaccination
- Planned vaccination (other than the study vaccination) during the entire study period
- Fever or any acute disease or infection within 3 days prior to vaccination
- Receipt of any antibiotics within 3 days before enrollment
- Coagulation disorder contraindicating intramuscular vaccination Any condition that in the opinion of the investigator would pose a health risk to the subject if enrolled or could interfere with the study procedures
- Current participation to another investigational study or planned enrollment to an investigational during the entire study period
- Planned surgery or hospitalization during the entire study period
- Subjects who participated in Cohort 1, 2 or 3, cannot be included in other different cohorts
- Pregnancy or breastfeeding (asking the woman to sign a declaration that she is not pregnant or breastfeeding).
- Any contraindication to the study vaccine (Bexsero®) as specified in the Summary of Product Characteristics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Safety, Tolerability and Immunogenicity of Two Doses of the 4CMenB Vaccine in Adults With an Immunodeficiency
The meningococcal quadrivalent conjugate vaccine (MenACWY) and the licenced multicomponent MenB vaccine (Bexsero®) have already been included in the Italian childhood immunization programme and recommendations for high risk categories have been also implemented.
As by NIP, vaccination against MenB with either 4CMenB or fHbp-MenB is offered for free for several conditions including subjects with severe primary or secondary immunodeficiency.
Read more
In Liguria Region meningococcal vaccination is actively offered to several chronic conditions including asplenia, patients with lymphoproliferative disease (also HSCT), subject treated with anti-CD20 mAb and HIV-positive.
In Liguria Region there is a large diverse population with risk condition that, as by national and regional recommendation, receive meningococcal vaccination. For some of them, i.e. asplenic and complement deficiencies groups, evidence have been generated through an ad hoc clinical trial, while for other important groups there is clear need of immunogenicity data.
In the proposed study, the Investigators plan to administer two doses of MenB vaccine (Bexsero®), 1-2 months apart, to adult patients living in Genoa area and belonging to following categories:
- Bone marrow transplant (HSCT patient)
- HIV positive
- Alfa-CD20 subjects (i.e. Patients candidates for / in treatment with biologic drugs such as Rituximab).
Immunogenicity data will be then obtained from sera collected at the day of the first Bexsero dose and one month after the immunization course by Serum Bactericidal Activity (SBA) assay.
- Conditions
- Acquired Immunodeficiency
- Being tested
- 4CMenB (Bexsero®) vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4CMenB (Bexsero®) vaccineBiological
Participants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Hematopoietic Stem Celi Transplant (HSCT) patients Receives: Biological: 4CMenB (Bexsero®) vaccine | |
| Cohort 2 | HIV infected subjects Receives: Biological: 4CMenB (Bexsero®) vaccine | |
| Cohort 3 | Patients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab) Receives: Biological: 4CMenB (Bexsero®) vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hSBA geometries mean titres (GMTs) against relevant MenB strains
hSBA geometries mean titres (GMTs) against relevant MenB strains
Measured: baseline (Visit 1) and one month after the second vaccination (Visit3).
4 fold increase in hSBA against relevant MenB
The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline to one month after the second vaccination (Visit3)
Measured: Baseline to one month after the second vaccination (Visit3)
hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination)
The proportion of subjects with "protective" hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination).
Measured: One month after the second vaccination (Visit3)
Secondary outcomes (3)
Local and systemic AEs
The incidence of subjects with solicited local and systemic AEs (Pain, Erythema, Swelling, Induration, Fever -body temperature ~38.0°C-, Nausea, Myalgia, Arthralgia, Headache, Fatigue) up to 7 days (including the day of vaccination) after Visits 1 and 2.
Measured: 7 days (including the day of vaccination) after Visits 1 and 2.
Unsolicited AEs
The incidence of subjects with any other unsolicited AEs up to 7 days (including the day of vaccination) after Visits 1 and 2.
Measured: 7 days (including the day of vaccination) after Visits 1 and 2.
SAEs and AEs leading to withdrawal and medically attended visits throughout the study period
The incidence of subjects with SAEs and AEs leading to withdrawal and medically attended visits throughout the study period
Measured: An average of 15 months (from the day of first vaccination to the end of the study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start6 Feb 2020
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acquired ImmunodeficiencyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Policlinico San Martino
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Laura Sticchi, Ospedale Policlinico San Martino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295733
- Sponsor's protocol ID
- 4CMenB
- Acronym
- 4CMenB
- Status last verified
- Jan 2024
- First submitted
- 24 Feb 2020
- Last updated
- 22 Jan 2024
- Results posted
- No
- Individual data sharing
- Undecided
Publications
Miller EC, Chase NM, Densen P, Hintermeyer MK, Casper JT, Atkinson JP. Autoantibody stabilization of the classical pathway C3 convertase leading to C3 deficiency and Neisserial sepsis: C4 nephritic factor revisited. Clin Immunol. 2012 Dec;145(3):241-50. doi: 10.1016/j.clim.2012.09.007. Epub 2012 Sep 28.
PubMed 23117396Salit IE. Meningococcemia caused by serogroup W135. Association with hypogammaglobulinemia. Arch Intern Med. 1981 Apr;141(5):664-5.
PubMed 6784688Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731.
PubMed 24166695Abio A, Neal KR, Beck CR. An epidemiological review of changes in meningococcal biology during the last 100 years. Pathog Glob Health. 2013 Oct;107(7):373-80. doi: 10.1179/2047773213Y.0000000119. Epub 2013 Dec 19.
PubMed 24392681Cohn AC, MacNeil JR, Harrison LH, Hatcher C, Theodore J, Schmidt M, Pondo T, Arnold KE, Baumbach J, Bennett N, Craig AS, Farley M, Gershman K, Petit S, Lynfield R, Reingold A, Schaffner W, Shutt KA, Zell ER, Mayer LW, Clark T, Stephens D, Messonnier NE. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010 Jan 15;50(2):184-91. doi: 10.1086/649209.
PubMed 20001736Crum-Cianflone N, Sullivan E. Meningococcal Vaccinations. Infect Dis Ther. 2016 Jun;5(2):89-112. doi: 10.1007/s40121-016-0107-0. Epub 2016 Apr 16.
PubMed 27086142Conferenza Stato-Regioni il 19 gennaio 2017. Piano Nazionale Prevenzione Vaccinale 2017-2019 (PNPV). Gazzetta Ufficiale del 18 febbraio 2017
Regione Liguria DGR n. 284 del 07/04/2017. Piano Regionale in Prevenzione Vaccinaleaggiornamento 2017. http://www.alisa.liguria.it/index.php?option=com_docman&task=search_result<emi d=323.
Martinon-Torres F, Bernatowska E, Shcherbina A, Esposito S, Szenborn L, Marti MC, Hughes S, Faust SN, Gonzalez-Granado LI, Yu LM, D'Agostino D, Calabresi M, Toneatto D, Snape MD. Meningococcal B Vaccine Immunogenicity in Children With Defects in Complement and Splenic Function. Pediatrics. 2018 Sep;142(3):e20174250. doi: 10.1542/peds.2017-4250. Epub 2018 Aug 1.
PubMed 30068713Ram S, Lewis LA, Rice PA. Infections of people with complement deficiencies and patients who have undergone splenectomy. Clin Microbiol Rev. 2010 Oct;23(4):740-80. doi: 10.1128/CMR.00048-09.
PubMed 20930072Sticchi L, Di Biagio A, Domnich A, Inglese M, Mikulska M, Louth J, Borrow R, Di Grazia C, Lapucci C, Bassetti M, Icardi G. Immunogenicity and safety of two doses of the four-component recombinant meningococcal B (4CMenB) vaccine in adults with immunodeficiency. Vaccine. 2026 Mar 19;76:128295. doi: 10.1016/j.vaccine.2026.128295. Epub 2026 Feb 12.
PubMed 41687362
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Tolerability and Immunogenicity of Two Doses of the 4CMenB Vaccine in Adults With an Immunodeficiency
- ClinicalTrials.gov ID
- NCT04295733
- Acronym / sponsor ID
- 4CMenB / 4CMenB
- Conditions
- Acquired Immunodeficiency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ospedale Policlinico San MartinoUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 4 Mar 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.
The meningococcal quadrivalent conjugate vaccine (MenACWY) and the licenced multicomponent MenB vaccine (Bexsero®) have already been included in the Italian childhood immunization programme and recommendations for high risk categories have been also implemented.
As by NIP, vaccination against MenB with either 4CMenB or fHbp-MenB is offered for free for several conditions including subjects with severe primary or secondary immunodeficiency.
In Liguria Region meningococcal vaccination is actively offered to several chronic conditions including asplenia, patients with lymphoproliferative disease (also HSCT), subject treated with anti-CD20 mAb and HIV-positive.
In Liguria Region there is a large diverse population with risk condition that, as by national and regional recommendation, receive meningococcal vaccination. For some of them, i.e. asplenic and complement deficiencies groups, evidence have been generated through an ad hoc clinical trial, while for other important groups there is clear need of immunogenicity data.
In the proposed study, the Investigators plan to administer two doses of MenB vaccine (Bexsero®), 1-2 months apart, to adult patients living in Genoa area and belonging to following categories:
- Bone marrow transplant (HSCT patient)
- HIV positive
- Alfa-CD20 subjects (i.e. Patients candidates for / in treatment with biologic drugs such as Rituximab).
Immunogenicity data will be then obtained from sera collected at the day of the first Bexsero dose and one month after the immunization course by Serum Bactericidal Activity (SBA) assay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Biological: 4CMenB (Bexsero®) vaccineHematopoietic Stem Celi Transplant (HSCT) patients |
| Cohort 2 | – | Biological: 4CMenB (Bexsero®) vaccineHIV infected subjects |
| Cohort 3 | – | Biological: 4CMenB (Bexsero®) vaccinePatients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 18 to 65 years with an acquired immune deficiency, including three study groups: * Cohort l-Hematopoietic Stem Celi Transplant (HSCT) patients * Cohort 2-HIV infected subjects * Cohort 3-patients candidates for / in treatment with biological drugs such as monoclonal antibodies anti CD-20 (rituximab or ocrelizumab)
Key inclusion criteria (6 listed)
- Males and females 18 through 65 years of age at the time of enrollment who are high risk for IMD, including subjects with documented medical history of any of the following criteria:
- Written informed consent obtained from the subject (or legal representative).
- Subjects (or legal representative) who are able to comprehend all procedures and to comply with the study requirements
Key exclusion criteria (18 listed)
- Subjects not able to understand and to adhere to ali study procedures
- Subjects aged <18 or >65 years
- Known or suspected allergy/hypersensitivity to any vaccine component
- History of serious adverse reaction to any vaccine
- Administration of immunoglobulins and/or any blood products within 3 months prior to enrollment or planned administration during the entire study period
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 |
|---|---|---|
| 4CMenB (Bexsero®) vaccineParticipants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
hSBA geometries mean titres (GMTs) against relevant MenB strains
Time frame: baseline (Visit 1) and one month after the second vaccination (Visit3).
hSBA geometries mean titres (GMTs) against relevant MenB strains
4 fold increase in hSBA against relevant MenB
Time frame: Baseline to one month after the second vaccination (Visit3)
The proportion of subjects with at least 4 fold increase in hSBA against relevant MenB strains from baseline to one month after the second vaccination (Visit3)
hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination)
Time frame: One month after the second vaccination (Visit3)
The proportion of subjects with "protective" hSBA titres >1:4 against relevant MenB strains at Visit3 (one month after the second vaccination).
3 secondary outcomes
Local and systemic AEs
Time frame: 7 days (including the day of vaccination) after Visits 1 and 2.
Unsolicited AEs
Time frame: 7 days (including the day of vaccination) after Visits 1 and 2.
SAEs and AEs leading to withdrawal and medically attended visits throughout the study period
Time frame: An average of 15 months (from the day of first vaccination to the end of the study)
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 22 Jan 2024.
- Background: PubMed 23117396Miller EC, Chase NM, Densen P, Hintermeyer MK, Casper JT, Atkinson JP. Autoantibody stabilization of the classical pathway C3 convertase leading to C3 deficiency and Neisserial sepsis: C4 nephritic factor revisited. Clin Immunol. 2012 Dec;145(3):241-50. doi: 10.1016/j.clim.2012.09.007. Epub 2012 Sep 28.
- Background: PubMed 6784688Salit IE. Meningococcemia caused by serogroup W135. Association with hypogammaglobulinemia. Arch Intern Med. 1981 Apr;141(5):664-5.
- Background: PubMed 24166695Miller L, Arakaki L, Ramautar A, Bodach S, Braunstein SL, Kennedy J, Steiner-Sichel L, Ngai S, Shepard C, Weiss D. Elevated risk for invasive meningococcal disease among persons with HIV. Ann Intern Med. 2014 Jan 7;160(1):30-7. doi: 10.7326/0003-4819-160-1-201401070-00731.
- Background: PubMed 24392681Abio A, Neal KR, Beck CR. An epidemiological review of changes in meningococcal biology during the last 100 years. Pathog Glob Health. 2013 Oct;107(7):373-80. doi: 10.1179/2047773213Y.0000000119. Epub 2013 Dec 19.
- Background: PubMed 20001736Cohn AC, MacNeil JR, Harrison LH, Hatcher C, Theodore J, Schmidt M, Pondo T, Arnold KE, Baumbach J, Bennett N, Craig AS, Farley M, Gershman K, Petit S, Lynfield R, Reingold A, Schaffner W, Shutt KA, Zell ER, Mayer LW, Clark T, Stephens D, Messonnier NE. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010 Jan 15;50(2):184-91. doi: 10.1086/649209.
- Background: PubMed 27086142Crum-Cianflone N, Sullivan E. Meningococcal Vaccinations. Infect Dis Ther. 2016 Jun;5(2):89-112. doi: 10.1007/s40121-016-0107-0. Epub 2016 Apr 16.
- BackgroundConferenza Stato-Regioni il 19 gennaio 2017. Piano Nazionale Prevenzione Vaccinale 2017-2019 (PNPV). Gazzetta Ufficiale del 18 febbraio 2017
- BackgroundRegione Liguria DGR n. 284 del 07/04/2017. Piano Regionale in Prevenzione Vaccinaleaggiornamento 2017. http://www.alisa.liguria.it/index.php?option=com_docman&task=search_result<emi d=323.
- Background: PubMed 30068713Martinon-Torres F, Bernatowska E, Shcherbina A, Esposito S, Szenborn L, Marti MC, Hughes S, Faust SN, Gonzalez-Granado LI, Yu LM, D'Agostino D, Calabresi M, Toneatto D, Snape MD. Meningococcal B Vaccine Immunogenicity in Children With Defects in Complement and Splenic Function. Pediatrics. 2018 Sep;142(3):e20174250. doi: 10.1542/peds.2017-4250. Epub 2018 Aug 1.
- Results publication: PubMed 20930072Ram S, Lewis LA, Rice PA. Infections of people with complement deficiencies and patients who have undergone splenectomy. Clin Microbiol Rev. 2010 Oct;23(4):740-80. doi: 10.1128/CMR.00048-09.
- Derived from this study: PubMed 41687362Sticchi L, Di Biagio A, Domnich A, Inglese M, Mikulska M, Louth J, Borrow R, Di Grazia C, Lapucci C, Bassetti M, Icardi G. Immunogenicity and safety of two doses of the four-component recombinant meningococcal B (4CMenB) vaccine in adults with immunodeficiency. Vaccine. 2026 Mar 19;76:128295. doi: 10.1016/j.vaccine.2026.128295. Epub 2026 Feb 12.
- Individual participant dataSharing planned: Undecided
Related trials for Acquired Immunodeficiency
Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acquired Immunodeficiency, run by Ospedale Policlinico San Martino at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 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 22 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 1 site in Italy. 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.
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?
hSBA geometries mean titres (GMTs) against relevant MenB strains (time frame: baseline (Visit 1) and one month after the second vaccination (Visit3).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295733, which also lists 11 linked publications.
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 22 Jan 2024.