Malaria,FalciparumPhase 1/2NCT05790889

A Study to Test Experimental Blood Stage Malaria Vaccine in Burkina Faso.

A Phase 1/2 study testing Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M and RH5.2 5μg adjuvated with 50μg Matrix-M in people with Malaria,Falciparum, run by University of Oxford at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a Phase IIb randomised controlled trial of the safety, immunogenicity and efficacy of the blood-stage malaria vaccine candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in infants aged 5-17 months in Burkina Faso Read more about this study

Who is it for?: Ages 5 to 17 monthsHealthy volunteers can take part
Conditions the study is for: Malaria,Falciparum
What is being tested?: Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M and RH5.2 5μg adjuvated with 50μg Matrix-M
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 390 participants
Where: 1 siteBurkina Faso
Study dates: 3 Apr 2023to 16 Oct 2026
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 5 to 17 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy infant aged 5-17 months at the time of first study vaccination
Parent/guardian provides signed/thumb-printed informed consent
Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.

Who cannot join

Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Sickle cell disease.

Show all 14Show fewer

Clinically significant laboratory abnormality as judged by the study clinician.
Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.
Receipt of any vaccine in the 7 days preceding enrolment, or planned receipt of any other vaccine within 7 days following each study vaccination.
History of vaccination with another malaria vaccine.
Participation in another research study involving receipt of an investigational product in the 30 days preceding enrolment, or planned use during the study period.
Known maternal HIV infection (no testing will be done by the study team).
Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (for corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day; inhaled and topical steroids are allowed).
Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

Institut de Recherche en Sciences de la Santé
Siglé, Boulkiemdé Province, BP 7192 OUAGADOUGOU 03, BF

Other trials in Burkina Faso

About this study

Official title: A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.

Read the detailed description

During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M.

During recruitment to Groups 3, 4 and 5, participants will be randomised 1:2:2 to receive vaccination with rabies control vaccination, RH5.1/Matrix-M or RH5.2-VLP/Matrix-M Efficacy of vaccination will be assessed by comparing the incidence of malaria cases in the pooled control groups (Groups 1 and 3) to the incidence of malaria in each investigational vaccine group (Groups 2,4 and 5).

There are three study vaccines: the IMP, 10μg RH5.1 adjuvanted with Matrix-M; 5μg RH5.2-VLP and Rabies Vaccine. Participants will receive the first vaccination of RH5.1 10μg with 50μg Matrix-M (Groups 2 and 4) or RH5.2 5μg with 50μg Matrix-M (Group 5). After approximately 4 weeks, a second dose will be administered, followed by a third and final vaccination approximately 4 weeks later (Groups 3-5) or approximately 4 months later (Groups 1-2). Second and third vaccinations will be administered at the same dose of both vaccine and adjuvant as at the initial vaccination and will be given within the window period of 5 months. Volunteers will be followed for 12 months from final vaccination.

The trial is funded by EDCTP grant number RIA2016V-1649-MMVC and by a Wellcome Trust Translational Award (205981/Z/17/Z)

Conditions: Malaria,Falciparum
Being tested: Rabies vaccine, RH5.1 10μg adjuvated with 50μg Matrix-M, RH5.2 5μg adjuvated with 50μg Matrix-M
Medical subject headings: Malaria, Falciparum

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rabies vaccineBiological
Vaccine
RH5.1 10μg adjuvated with 50μg Matrix-MBiological
Vaccine
RH5.2 5μg adjuvated with 50μg Matrix-MBiological
Vaccine

Study groups in NCT05790889
Study group	Role	What they receive
Group 1 (Control group)	Placebo comparator	n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 152. Receives: Biological: Rabies vaccine
Group 2	Experimental	n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 152. Receives: Biological: RH5.1 10μg adjuvated with 50μg Matrix-M
Group 3 (Control Group)	Placebo comparator	n= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 56. Receives: Biological: Rabies vaccine
Group 4	Experimental	n=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56. Receives: Biological: RH5.1 10μg adjuvated with 50μg Matrix-M
Group 5	Experimental	n=120 Age= 5-17 months First vaccination of RH5.2-VLP 5μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56. Receives: Biological: RH5.2 5μg adjuvated with 50μg Matrix-M

What is being measured

The primary outcome is the main question the study is designed to answer.

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature higher than 37.5 degree celsius and P. Falciparum parasite density >5000 asexual forms/µL)
Measured: From 14 days after the third study vaccination until 6 months after the third study vaccination.
To assess the safety and reactogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits
Measured: The month following each vaccination and at 6 and 12 months after administration of the final dose of vaccine.

Secondary outcomes (8)

To assess the humoral immunogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
The following measures will be assessed
- Serum ELISA response:
1. Quantitative antigen-specific IgG antibody levels (µg/mL readout) over time - analysis of peak responses and longevity; 2. Antigen-specific antibody subclass/isotype measurement; 3. Antigen-specific antibody avidity measurement; In vitro GIA against 3D7 clone P. falciparum parasites using purified total IgG and a single-cycle pLDH readout assay
- Purified IgG ELISA versus GIA titration "Quality Analysis"
Measured: Immunology blood samples will be collected at screening, day of vaccination (V) 1, 14 & 28 days post V2, day of V3, 14 days post V3, 2, 6 and 12 months post V3.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 3 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL).
Measured: From 14 days after the third study vaccination until 3 months after the third study vaccination
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area
Occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits
Measured: For 12 months after the last vaccination
To assess the protective efficacy against asymptomatic P. falciparum infection of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
Efficacy tested by conducting qPCR analysis
Measured: At 6 and 12 months after administration of the final dose of vaccine.
To assess the protective efficacy against asymptomatic P. falciparum infection against gametocytaemia of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
The proportion of participants in each study arm that show presence of parasite density >5000 asexual forms/µL as measured by quantitative reverse-transcriptase PCR PLUS presence of axillary temperature <37.5°C and absence of history of fever within the last 24 hours. The proportion of participants in each study arm that show presence of parasite density >0 asexual forms/µL as measured by quantitative reverse-transcriptase PCR PLUS presence of axillary temperature <37.5°C and absence of history of fever within the last 24 hours.
Measured: At 6 and 12 months post third study vaccination.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area for 12 months after the last vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature ≥37.5°C and P. falciparum parasite density >5000 asexual forms/µL).
Measured: From 14 days after the third study vaccination until 12 months after the third study vaccination
To assess the protective efficacy against gametocytaemia of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area, by qPCR at 2 and 6 months after administration of the final dose of vaccine
The proportion of participants in each study arm that show presence of gametocytes >0 gametocytes/μL as measured by quantitative reverse-transcriptase PCR.
Measured: At 2 and 6 months post third study vaccination.
Efficacy against incident severe anaemia and blood transfusion requirement
The proportion of participants in each study arm with documented Hb <5.0 g/dL identified at clinical presentation in association with P. falciparum asexual parasitaemia > 5000 parasites/µL. The proportion of participants in each study arm with documented Hb <5.0 g/dL identified at clinical presentation and requirement for a blood transfusion.
Measured: From 14 days after the third study vaccination until 6 months after the third study vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 202316 Oct 2026

First posted30 Mar 2023
Study start3 Apr 2023
Primary completion16 Oct 2026
Study completion16 Oct 2026

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 Malaria,FalciparumStudies 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 1/2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05790889
Sponsor's protocol ID: VAC091
Status last verified: Oct 2026
First submitted: 16 Jan 2023
Last updated: 21 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Natama HM, Salkeld J, Some A, Soremekun S, Diallo S, Traore O, Rouamba T, Ouedraogo F, Ouedraogo E, Dabone KCS, Kone NA, Compaore ZMJ, Kafando M, Bonko MDA, Konate F, Sorgho H, Nielsen CM, Pipini D, Diouf A, King LDW, Shaligram U, Long CA, Cho JS, Lawrie AM, Skinner K, Roberts R, Miura K, Bradley J, Silk SE, Draper SJ, Tinto H, Minassian AM. Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. Lancet Infect Dis. 2025 May;25(5):495-506. doi: 10.1016/S1473-3099(24)00752-7. Epub 2024 Dec 10.
PubMed 39672183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIb Randomised Controlled Trial of the Safety, Immunogenicity and Efficacy of the Blood-stage Malaria Vaccine Candidates RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in Infants Aged 5-17 Months in Burkina Faso.
ClinicalTrials.gov ID: NCT05790889
Acronym / sponsor ID: VAC091
Conditions: Malaria,Falciparum
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 390 participants (actual)
Lead sponsor: University of OxfordUniversity, hospital or other
Collaborators: Institut de Recherche en Sciences de la Sante, Burkina Faso, European and Developing Countries Clinical Trials Partnership (EDCTP), Wellcome Trust
Study start: 3 Apr 2023 (actual)
Primary completion: 16 Oct 2026 (actual)
Study completion: 16 Oct 2026 (actual)
First posted: 30 Mar 2023 (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.

Detailed description

During the initial recruitment to Groups 1 and 2, participants will be randomised 1:2 to receive vaccination with the rabies control vaccination or RH5.1/Matrix-M.

The trial is funded by EDCTP grant number RIA2016V-1649-MMVC and by a Wellcome Trust Translational Award (205981/Z/17/Z)

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Group 1 (Control group)	Placebo comparator	Biological: Rabies vaccinen= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 152.
Group 2	Experimental	Biological: RH5.1 10μg adjuvated with 50μg Matrix-Mn=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 152.
Group 3 (Control Group)	Placebo comparator	Biological: Rabies vaccinen= 60. Age= 5-17 months Rabies Vaccine administered on Days 0, 28 and 56.
Group 4	Experimental	Biological: RH5.1 10μg adjuvated with 50μg Matrix-Mn=120 Age= 5-17 months First vaccination of RH5.1 10μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.
Group 5	Experimental	Biological: RH5.2 5μg adjuvated with 50μg Matrix-Mn=120 Age= 5-17 months First vaccination of RH5.2-VLP 5μg with 50μg Matrix-M will be administered on day 0, followed by a second dose administered on Day 28, followed by a third and final dose at Day 56.

Who may qualify

Ages: 5 to 17 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy infant aged 5-17 months at the time of first study vaccination
Parent/guardian provides signed/thumb-printed informed consent
Infant and parent/guardian resident in the study area villages and anticipated to be available for vaccination and follow-up for 12 months following last dose of vaccination.

Key exclusion criteria (14 listed)

Clinically significant congenital abnormalities as judged by the PI or other delegated individual.
Clinically significant skin disorder (psoriasis, contact dermatitis etc.), cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness as judged by the PI or other delegated individual.
Weight-for-age Z score of less than -3 or other clinical signs of malnutrition.
History of allergic reaction, significant IgE-mediated event, or anaphylaxis to immunization.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

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
Rabies vaccineVaccine	Biological	Group 1 (Control group), Group 3 (Control Group)
RH5.1 10μg adjuvated with 50μg Matrix-MVaccine	Biological	Group 2, Group 4
RH5.2 5μg adjuvated with 50μg Matrix-MVaccine	Biological	Group 5

Primary outcome

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination.
Time frame: From 14 days after the third study vaccination until 6 months after the third study vaccination.
Time to first episode of clinical malaria (defined as the presence of axillary temperature higher than 37.5 degree celsius and P. Falciparum parasite density >5000 asexual forms/µL)
To assess the safety and reactogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
Time frame: The month following each vaccination and at 6 and 12 months after administration of the final dose of vaccine.
Occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits

8 secondary outcomes

To assess the humoral immunogenicity of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area.
Time frame: Immunology blood samples will be collected at screening, day of vaccination (V) 1, 14 & 28 days post V2, day of V3, 14 days post V3, 2, 6 and 12 months post V3.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 3 months after the last vaccination.
Time frame: From 14 days after the third study vaccination until 3 months after the third study vaccination
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area
Time frame: For 12 months after the last vaccination
To assess the protective efficacy against asymptomatic P. falciparum infection of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
Time frame: At 6 and 12 months after administration of the final dose of vaccine.
To assess the protective efficacy against asymptomatic P. falciparum infection against gametocytaemia of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area, by qPCR.
Time frame: At 6 and 12 months post third study vaccination.
To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area for 12 months after the last vaccination.
Time frame: From 14 days after the third study vaccination until 12 months after the third study vaccination
To assess the protective efficacy against gametocytaemia of RH5.1 in Matrix-M and RH5.2-VLP in Matrix-M in 5-17 months old children living in a malaria-endemic area, by qPCR at 2 and 6 months after administration of the final dose of vaccine
Time frame: At 2 and 6 months post third study vaccination.
Efficacy against incident severe anaemia and blood transfusion requirement
Time frame: From 14 days after the third study vaccination until 6 months after the third study vaccination.

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 21 Oct 2026.
Derived from this study: PubMed 39672183Natama HM, Salkeld J, Some A, Soremekun S, Diallo S, Traore O, Rouamba T, Ouedraogo F, Ouedraogo E, Dabone KCS, Kone NA, Compaore ZMJ, Kafando M, Bonko MDA, Konate F, Sorgho H, Nielsen CM, Pipini D, Diouf A, King LDW, Shaligram U, Long CA, Cho JS, Lawrie AM, Skinner K, Roberts R, Miura K, Bradley J, Silk SE, Draper SJ, Tinto H, Minassian AM. Safety and efficacy of the blood-stage malaria vaccine RH5.1/Matrix-M in Burkina Faso: interim results of a double-blind, randomised, controlled, phase 2b trial in children. Lancet Infect Dis. 2025 May;25(5):495-506. doi: 10.1016/S1473-3099(24)00752-7. Epub 2024 Dec 10.

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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.

Angela Minassian principal investigator

Honorary Consultant and Chief Investigator - Project clinical trials

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 14 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 21 Oct 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 Burkina Faso. 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. Some participants in this study may receive a placebo. 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?

To assess the protective efficacy against clinical malaria of RH5.1 in Matrix-MTM and RH5.2-VLP in Matrix-MTM in 5-17 months old children living in a malaria-endemic area for 6 months after the last vaccination. (time frame: From 14 days after the third study vaccination until 6 months after the third study vaccination.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05790889, 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 21 Oct 2026.