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Lyme DiseasePhase 3VALORNCT05477524

An Efficacy, Safety, Tolerability, Immunogenicity, and Lot-Consistency Clinical Trial of a 6-Valent OspA-Based Lyme Disease Vaccine (VLA15)

A Phase 3 study testing VLA15 and Saline in people with Lyme Disease, run by Pfizer at 129 sites in 7 countries.

Completed

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

Official record
Search all trials

Trial summary

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older… Read more about this study

Who is it for?
Ages 5 years and olderHealthy volunteers can take part
Conditions the study is for
Lyme Disease
What is being tested?
VLA15 and Saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12,546 participants
Where
129 sitesin 7 countries
Study dates
4 Aug 2022to 7 Jan 2026
Phase
Phase 3
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Participants who reside in areas with endemic Lyme disease and who lead lifestyles that put them at increased risk for Lyme disease. For example, this could include, but not be limited to:
  • Individuals who work in B burgdorferi-infected/tick-infested areas, especially those with occupations that may be associated with higher risk of exposure, such as landscaping, forestry, and wildlife and parks management.
  • Individuals who pursue recreational activities such as hiking, camping, fishing, hunting, jogging, or gardening in such areas.
  • Individuals who live on land plots with tree lines and come into contact with these trees regularly.
  • Individuals who have dogs that regularly are outdoors and frequently return with attached ticks.
  • Individuals who participate in activities in areas with tall grass, smaller wooded areas beside forests, open fields, lakesides, and riversides.

Who cannot join

  • Any female participants that are pregnant (or have a positive urine pregnancy test) or are breastfeeding.
  • Any diagnosis of Lyme disease within the past 3 months.
  • Any history of Lyme carditis, neuroborreliosis, or arthritis, or other disseminated Lyme disease regardless of when diagnosed.
  • Known tick bite within the past 4 weeks.
  • Newly developed or unstable underlying conditions that may interfere with the assessment of Lyme disease, including but not limited to chronic arthralgia/arthritis, second/third-degree AV heart block, chronic pain syndromes, and chronic skin conditions that reduce the ability to detect cutaneous manifestations of Lyme disease.
  • Any unstable autoimmune condition with a manifestation (eg, arthritic and neurologic) that may interfere with the assessment of Lyme disease.
  • Chronic systemic doxycycline or minocycline or other tetracycline class drug use for acne or any other chronic suppressive antibiotics used to treat other conditions.

Trial locations and contacts

129 sites in 7 countries.

129 sites in 7 countries

United States82 sites

  • Care Access Mobile Site

    Aliquippa, Pennsylvania, 15001

  • Johns Hopkins

    Baltimore, Maryland, 21205

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • Northern Light Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Velocity Clinical Research, Binghamton

    Binghamton, New York, 13905

  • Care Access - Brattleboro - Putney Road

    Brattleboro, Vermont, 05301

  • Care Access - Brattleboro

    Brattleboro, Vermont, 05301

  • Internal Medicine Associates

    Bridgeton, New Jersey, 08302

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

  • Care Access Mobile Site

    Clarion, Pennsylvania, 16214

  • Bassett Medical Center

    Cooperstown, New York, 13326

  • Smith Allergy and Asthma Specialists

    Cortland, New York, 13045

  • TruCare Internal Medicine & Infectious Disease

    DuBois, Pennsylvania, 15801

  • Altoona Center For Clinical Research

    Duncansville, Pennsylvania, 16635

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Clinilabs

    Eatontown, New Jersey, 07724

  • Allegheny Health and Wellness Pavilion

    Erie, Pennsylvania, 16506

  • Central Erie Primary Care

    Erie, Pennsylvania, 16508

  • Care Access - Essex

    Essex, Connecticut, 06426

  • Pediatric Associates of Fall River

    Fall River, Massachusetts, 02721

  • Care Access - Farmington

    Farmington, Maine, 04938

  • Hunterdon Infectious Disease Specialists

    Flemington, New Jersey, 08822

  • Hunterdon Medical Center

    Flemington, New Jersey, 08822

  • Care Access Mobile Site

    Greensburg, Pennsylvania, 15601

  • Care Access - Albany

    Halfmoon, New York, 12065

  • Care Access Mobile Site

    Halfmoon, New York, 12065

  • Care Access - Mountaintop

    Hazle Township, Pennsylvania, 18202

  • CCP - Kid's Way

    Hermitage, Pennsylvania, 16148

  • Care Access - Hoboken

    Hoboken, New Jersey, 07030

  • Smith Allergy & Asthma Specialists

    Horseheads, New York, 14845

  • Care Access - Kingston

    Kingston, Pennsylvania, 18704

  • Care Access - Lakeville

    Lakeville, Massachusetts, 02347

  • Care Access Mobile Site

    Ledyard Center, Connecticut, 06339

  • Care Access - Londonderry

    Londonderry, New Hampshire, 03053

  • Johns Hopkins Rockland Physician Practice and Research Group

    Lutherville, Maryland, 21093

  • University Hospital and UW Health Clinics

    Madison, Wisconsin, 53792

  • Marshfield Medical Center - Marshfield

    Marshfield, Wisconsin, 54449

  • Care Access - Melrose

    Melrose, Massachusetts, 02176

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Care Access - Middlebury

    Middlebury (village), Vermont, 05753

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Care Access Mobile Site

    Monaca, Pennsylvania, 15061

  • Care Access - Briarpatch and Mobile Site

    Nantucket, Massachusetts, 02554

  • Care Access - Nantucket

    Nantucket, Massachusetts, 02554

  • Care Access Mobile Site

    Nantucket, Massachusetts, 02554

  • Care Access Mobile Site

    New London, Connecticut, 06320

  • Care Access Mobile Site

    New Shoreham, Rhode Island, 02807

  • Mid Hudson Medical Research

    New Windsor, New York, 12553

  • Care Access - North Conway

    North Conway, New Hampshire, 03860

  • South Shore Medical Center

    Norwell, Massachusetts, 02061

  • Care Access Mobile Site

    Oak Bluffs, Massachusetts, 02557

  • Preferred Primary Care Physicians, Preferred Clinical Research (Ofc 18)

    Pittsburgh, Pennsylvania, 15236

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania, 15243

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Care Access - Pottsville

    Pottsville, Pennsylvania, 17901

  • Care Access Mobile Site

    Punxsutawney, Pennsylvania, 15767

  • Care Access - Hingham

    Rockland, Massachusetts, 02370

  • MaineHealth Pen Bay Hospital

    Rockport, Maine, 04856

  • Care Access Mobile Site

    Sandwich, Massachusetts, 02563

  • Guthrie Medical Group, P.C.

    Sayre, Pennsylvania, 18840

  • Robert Packer Hospital

    Sayre, Pennsylvania, 18840

  • Frontier Clinical Research, LLC

    Scottdale, Pennsylvania, 15683

  • Care Access - Scranton

    Scranton, Pennsylvania, 18508

  • Northeast Clinical Trials Group

    Scranton, Pennsylvania, 18510

  • Care Access Mobile Site

    Sharon, Pennsylvania, 16146

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Sisu BHR

    Springfield, Massachusetts, 01103

  • Stamford Health Medical Group

    Stamford, Connecticut, 06902

  • Stamford Hospital

    Stamford, Connecticut, 06904

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Care Access Mobile Site

    Vineyard Haven, Massachusetts, 02568

  • Care Access - Wareham

    Wareham, Massachusetts, 02571

  • IMA Clinical Research Warren

    Warren Township, New Jersey, 07059

  • Care Access - Warwick

    Warwick, Rhode Island, 02886

  • Sumit Bhutani MD LLC

    Westminster, Maryland, 21157

  • Woodholme Gastroenterology Associates

    Westminster, Maryland, 21157

  • Marshfield Medical Center - Weston

    Weston, Wisconsin, 54476

  • South Shore Hospital

    Weymouth, Massachusetts, 02190

  • Care Access - Wilkes-Barre

    Wilkes-Barre, Pennsylvania, 18702

  • Amherst Family Practice, P.C.

    Winchester, Virginia, 22601

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

  • Care Access Mobile Site

    Yeagertown, Pennsylvania, 17099

Other trials in United States

Poland19 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-274

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-540

  • Zespol Opieki Zdrowotnej w Boleslawcu

    Bolesławiec, 59-700

  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-537

  • Indywidualna Specjalistyczna Praktyka Lekarska Roman Spyra

    Katowice, 40-018

  • Przylądek Zdrowia

    Krakow, Lesser Poland Voivodeship, 30-644

  • Krakowski Szpital Specjalistyczny im. Jana Pawa II

    Krakow, Lesser Poland Voivodeship, 31-202

  • Centrum Badan Klinicznych Jagiellonskie Centrum Innowacji

    Krakow, 30-348

  • Krakowskie Centrum Medyczne

    Krakow, 31-501

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym

    Łomianki, Masovian Voivodeship, 05-092

  • NZOZ Praktyka Lekarza Rodzinnego Eskulap

    Lublin, 20-044

  • Rodzinne Centrum Medyczne LUBMED

    Luboń, Greater Poland Voivodeship, 62-030

  • Centrum Medyczne Lucyna Andrzej Dymek

    Strzelce Opolskie, Opole Voivodeship, 47-100

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska

    Tarnów, Lesser Poland Voivodeship, 33-100

  • MICS Centrum Medyczne Torun

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

  • Szpital im. Św. Jadwigi Śląskiej w Trzebnicy

    Trzebnica, Lower Silesian Voivodeship, 55-100

  • Futuremeds spolka z ograniczona odpowiedzialnoscia

    Wroclaw, Lower Silesian Voivodeship, 53-673

  • Przychodnia EuroMediCare Wroclaw Lowiecka

    Wroclaw, 50-220

  • Centrum Medyczne AD-MED Sp. z o. o. Przychodnia Dla Rodziny

    Wroclaw, 51-141

Other trials in Poland

Canada10 sites

  • Viable Clinical Research Corporation

    Bridgewater, Nova Scotia, B4V 3N2

  • Centricity Research Burlington Multispecialty

    Burlington, Ontario, L7M 4Y1

  • Canadian Center for Vaccinology

    Halifax, Nova Scotia, B3K6R8

  • Milestone Research Inc.

    London, Ontario, N5W 6A2

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • Bluewater Clinical Research Group Inc.

    Sarnia, Ontario, N7T 4X3

  • Diex Recherche Sherbrooke

    Sherbrooke, Quebec, J1L 0H8

  • Stouffville Medical Research Institute Inc.

    Stouffville, Ontario, L4A 1H2

  • Centricity Research Toronto Manna Multispecialty

    Toronto, Ontario, M9W 4L6

  • Diex Recherche Inc. Division Victoriaville

    Victoriaville, Quebec, G6P 3Z8

Other trials in Canada

Finland9 sites

  • FVR, Etelä-Helsingin rokotetutkimusklinikka

    Helsinki, Uusimaa, 00100

  • FVR, Itä-Helsingin rokotetutkimusklinikka

    Helsinki, Uusimaa, 00930

  • MeVac - Meilahti Vaccine Research Center

    Helsinki, 00290

  • FVR, Järvenpään rokotetutkimusklinikka

    Jarvenpaa, Uusimaa, 04400

  • FVR, Kokkolan rokotetutkimusklinikka

    Kokkola, 67100

  • FVR, Porin rokotetutkimusklinikka

    Pori, 28100

  • FVR, Tampereen rokotetutkimusklinikka

    Tampere, Pirkanmaa, 33100

  • FVR, Turun rokotetutkimusklinikka

    Turku, Southwest Finland, 20520

  • Terveystalo Pulssi

    Turku, 20100

Other trials in Finland

Sweden6 sites

  • Blekinge Tekniska Hogskola (BTH) (Blekinge Institute of Technology) - Karlskrona

    Karlskrona, Blekinge LÄN [se-10], 371 79

  • ProbarE

    Lund, 222 22

  • Universitetssjukhuset Örebro

    Örebro, Örebro LÄN [se-18], 701 85

  • CTC Karolinska

    Solna, Stockholms LÄN [se-01], 171 64

  • Studieenheten Akademiskt Specialistcentrum

    Stockholm, Stockholms LÄN [se-01], 113 61

  • CTC MTC

    Uppsala, Uppsala LÄN [se-03], 752 37

Other trials in Sweden

Germany2 sites

  • AmBeNet GmbH

    Leipzig, Saxony, 04107

  • Internistische Gemeinschaftspraxis Mainz

    Mainz, 55116

Other trials in Germany

Netherlands1 site

  • Amsterdam UMC, locatie AMC

    Amsterdam, North Holland, 1105 AZ

Other trials in Netherlands

About this study

Official title: A PHASE 3, MULTICENTER, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, IMMUNOGENICITY, AND LOT CONSISTENCY OF A 6-VALENT OSPA-BASED LYME DISEASE VACCINE IN HEALTHY PARTICIPANTS ≥5 YEARS OF AGE

The main purpose of this clinical study is to evaluate a 6-valent OspA-based Lyme disease vaccine (VLA15) for prevention of Lyme disease within North America and Europe. Approximately 9,400 healthy participants (this number excludes participants from 8 sites which were terminated for quality issues) 5 years and older will be recruited from areas with high levels of endemic Lyme disease to receive VLA15 or placebo (an inactive substance consisting of saltwater). Each participant will have about a 50% chance of receiving VLA15 and about a 50% chance of receiving placebo. A subset of participants will receive VLA15 from 3 different lots or placebo (1:1:1:3 ratio) to assess lot equivalence.

Participants will receive a 3-dose primary vaccination series at about 0, 2, and 5 to 9 months and then receive a booster dose about 12 months after end of primary vaccination series. Vaccination of participants will occur at a time of year such that the primary series is completed before the peak Lyme disease season followed by a booster dose just prior to the beginning of the second Lyme disease season. A subset of participants will be followed for a third Lyme disease season.

Read more

Comparison will be made between the Lyme disease cases of people receiving the study vaccine to those of the people who are not. This will help us determine if the study vaccine is safe and effective.

If enrolled, participants will need to visit the research site at least 7 times during the study, and for a subset of participants up to 9 times. There will also be at least 5 telephone contacts. It is expected that each participant will take part in this study for up to about 2 and a half years. The subset of participants followed for a third Lyme disease season will take part in this study for up to about to 3 and a half years.

Conditions
Lyme Disease
Being tested
VLA15, Saline
Keywords
VLA15, Lyme Borreliosis, Vaccine, Tick
Medical subject headings
Lyme Disease

What participants receive

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

  • VLA15Biological

    Shot in the deltoid muscle (preferable in the nondominant arm)

  • SalineOther

    Shot in the deltoid muscle (preferable in the nondominant arm)

Study groups in NCT05477524
Study groupRoleWhat they receive
VLA15 Lot 1 (3-dose primary vaccination series and booster dose)ExperimentalShot in the deltoid muscle (preferable in the nondominant arm)
Receives: Biological: VLA15
VLA15 Lot 2 (3-dose primary vaccination series and booster dose)ExperimentalShot in the deltoid muscle (preferable in the nondominant arm)
Receives: Biological: VLA15
VLA15 Lot 3 (3-dose primary vaccination series and booster dose)ExperimentalShot in the deltoid muscle (preferable in the nondominant arm)
Receives: Biological: VLA15
Placebo (3-dose primary vaccination series and booster dose)Placebo comparatorShot in the deltoid muscle (preferable in the nondominant arm)
Receives: Other: Saline

What is being measured

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

  1. Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group

    A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the independent Adjudication Committee

    Measured: Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).

  2. Percentage of participants reporting local reactions

    Measured: Within 7 days following each study intervention administration

  3. Percentage of participants reporting systemic events

    Measured: Within 7 days following each study intervention administration

  4. Percentage of participants reporting adverse events (AEs)

    Measured: Through 1 month following each study intervention administration

  5. Percentage of participants reporting newly diagnosed chronic medical conditions (NDCMCs)

    Measured: Through study completion, up to approximately 42 months.

  6. Percentage of participants reporting serious adverse events (SAEs)

    Measured: Through study completion, up to approximately 42 months.

  7. Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 2

    Measured: At 1 month after completion of the primary series and the booster dose

  8. Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 1 to Lot 3

    Measured: At 1 month after completion of the primary series and the booster dose

  9. Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6) for Lot 2 to Lot 3

    Measured: At 1 month after completion of the primary series and the booster dose

  10. Geometric mean ratio (GMR) of anti-OspA titers for each serotype (ST1-ST6)

    Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata using GMRs 1 month after completion of booster dose.

    Measured: At 1 month after completion of the booster dose

  11. Sero-response of anti-OspA IgG concentrations for each serotype (ST1-ST6)

    Immunobridging objective to determine non-inferiority between 5-17 year old and 18-44 year old participant strata using difference in seroresponse rates 1 month after completion of booster dose.

    Measured: At 1 month after completion of the booster dose

Secondary outcomes (2)

  1. Vaccine efficacy among participants enrolled from North American sites

    A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the independent Adjudication Committee

    Measured: Through the end of the Lyme disease season beginning 1 month after receiving the booster dose (28 days after completion of the booster dose until end of October)

  2. Vaccine efficacy among participants after primary series

    A confirmed case of Lyme disease, caused by B burgdorferi sensu lato, is defined as a clinically suspected case of Lyme disease that is confirmed by PCR, culture, microbial cell-free B burgdorferi-specific DNA sequencing, or serological antiborrelial antibody assay, and finally assessed and confirmed to be a case by the independent Adjudication Committee

    Measured: Through the end of the Lyme disease season beginning 1 month after completing the primary series (28 days after completion of the primary series until end of October)

Timeline

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

  1. First posted28 Jul 2022
  2. Study start4 Aug 2022
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
12,546 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477524
Sponsor's protocol ID
C4601003
Other IDs
2023-509105-72-00, 2023
Acronym
VALOR
Status last verified
Jun 2026
First submitted
5 Jul 2022
Last updated
4 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Dreyfus J, Munnangi S, Bengtsson C, Correia B, Figueiredo R, Stark JH, Zawora M, Riddle MS, Maguire JD, Jiang Q, Ianos C, Naredo Turrado J, Svanstrom H, Bailey S, DeKoven M. Background incidence rates of health outcomes in populations at risk for Lyme disease using US administrative claims data. Vaccine. 2024 Feb 15;42(5):1094-1107. doi: 10.1016/j.vaccine.2024.01.037. Epub 2024 Jan 22.

    PubMed 38262807

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing VLA15 and Saline in people with Lyme Disease, run by Pfizer at 129 sites in 7 countries.

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 7 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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 129 sites in United States, Poland, Canada, Finland, Sweden and 2 more countries. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Relative incidence rate reduction of confirmed Lyme disease cases in the VLA15 group compared to the placebo group (time frame: Beginning 1 month after receiving the booster dose (28 days after receiving the booster dose through the end of the Lyme disease season following the booster dose (end of October)).). The study lists 11 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 NCT05477524, 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 Jun 2026.

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