Ewing SarcomaPhase 1/2PerVisionNCT06094101
Personalized Vaccination in Fusion+ Sarcoma Patients (PerVision)
A Phase 1/2 study testing Peptide vaccine IPX in people with Ewing Sarcoma and Rhabdomyosarcoma, run by University Hospital Tuebingen at 4 sites in Germany.
Trial summary
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor. Read more about this study
- Who is it for?
- Ages 2 to 40 years
- Conditions the study is for
- Ewing Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma
- What is being tested?
- Peptide vaccine IPX
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesGermany
- Study dates
- 19 Sep 2023to Sep 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 2 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- Ejection fraction < 25%
- Creatinine-clearance < 40ml/min
- Bilirubin > 4mg/dl
- Alanine aminotransferase (ALT) > 400 units (U)/l and/or aspartate aminotransferase (AST) > 400 U/l
- Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen/antibody or nucleic acid tests [NAT]) and CD4-positive cells < 500/μl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody [HBcAb] or positive hepatitis B surface antigen [HBsAg]) and hepatitis B NAT test > 2000 IU/ml). Hepatitis C virus: positive for heavy chain only antibody [HCAb] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)
- Subjects with a known hypersensitivity / allergy to any component of the study drugs.
Show all 20Show fewer
- Subjects who have received a live, attenuated vaccine within 28 days prior to the administration of the study drug (only stage 2).
- Subjects with a prior haematopoietic stem cell transplantation / prior organ transplantation.
- Patients suffering from other malignancies (with the exception of those with a negligible risk of metastasis or death and treated with curative outcome) within 5 years prior to study start.
- Current or anticipated need for any of the following medications interfering with T cell function from 14 days before 1st vaccination until 28 days after 1st vaccination: Immunosuppressive agents, which influence functionality and activity of T cells, such as steroids (more than 0,5 mg/kg body weight prednisolone-equivalent), calcineurin-inhibitors, mofetil mycophenolate, sirolimus, everolimus, and cytotoxic medication. Those drugs should be avoided until 28 days after third/final vaccination but may be given after discussion with the principal investigator. Application of tyrosine kinase inhibitors is permitted during the trial (only stage 2).
- Significant psychiatric disabilities that, in the judgment of the investigator, do not assure reliable participation in the present study.
- Uncontrolled seizure disorders (occurrence of at least one generalized seizure in the last 3 months) or severe peripheral neuropathy/leucoencephalopathy (> grade 2 according to NCI CTCAE v5.0 neurotoxicity criteria).
- Autoimmune disease (e.g. idiopathic thrombocytopenic purpura, autoimmune hemolytic anemia, autoimmune dermatitis) requiring immunosuppressive treatment
- Pregnant females
- Female subjects of childbearing potential (postmenarcheal, with an intact uterus and at least one ovary, and less than one year postmenopausal) not agreeing to use acceptable method(s) of contraception from 30 days prior to Screening stage 2 visit to 180 days after the last vaccination.
- Male subjects of reproductive capacity not agreeing to use effective contraception from first vaccination of this study to 180 days after the last vaccination.
- Not willing and/or not able to comply with treatment plan, scheduled visits, laboratory tests, contraceptive guidelines and other study procedures.
- History of any illness or clinical condition that might confound the results of the study or pose an additional risk in administering study drug to the subject, according to the judgement of the investigator. This may include but is not limited to: history of central nervous system or cardiovascular disease, history of relevant drug allergies, history of psychiatric disorder, history or present of clinically significant pathology.
- Karnofsky performance status of < 70% for subjects ≥ 16 years of age, Lansky performance status of < 70% for subjects < 16 years of age
- Participation or intended participation in another clinical phase I or II trial with an investigational drug or product within 28 days prior to enrollment (with the exception to participation of the "frontline and relapsed rhabdomyosarcoma study"( (FaR-RMS) after completion of the maintenance therapy (EudraCT-2018-000515-24)). Commonly used drugs as per standard or phase III-trials are permitted.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Joachim Rupprecht, Dr. contact
Germany4 sites, 4 recruiting
- Not yet recruiting
Pediatrics III, West German Cancer Centre, University Hospital
Essen, 45147
Uta Dirksen, Prof., 0049.201.7238084, uta.dirksen@uk-essen.de
Dirk Reinhardt, 0049-201-7233784, dirk.reinhardt@uk-essen.de
- Not yet recruiting
Universitätsklinikum, Klinik für Kinder- und Jugendmedizin
Frankfurt am Main, 60590
Konrad Bochennek, Dr., +49 69 6301-5243
Eva Rettinger, Dr., +49 69 6301-5040
- Not yet recruiting
Zentrum für Kinder- und Jugendmedizin, Universitätsklinikum
Freiburg im Breisgau, 79106
Simone Hettmer, Prof. Dr., +49 761 27043000, simone.hettmer@uniklinik-freiburg.de
Christian Flotho, Prof. Dr., +49 761 27046280, christian.flotho@uniklinik-freiburg.de
- Recruiting
University Children's Hostpital
Tübingen, 72076
Martin Ebinger, Prof. Dr., +49 7071 2983781, martin.ebinger@med.uni-tuebingen.de
Joachim Rupprecht, Dr., joachim.rupprecht@med.uni-tuebingen.de
About this study
Official title: Prospective Phase I/II Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.
This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.
Read more
It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine.
Primary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.
Read the detailed description
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides (one peptide derived from the sarcoma-specific fusion breakpoint, 'fusion-peptide', and a second peptide derived from neoantigens derived from patient-specific non-synonymous mutations with the highest prediction score, 'mutation-based neopeptide') in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.
This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.
It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine and the toll like receptor (TLR) 1/2 ligand XS15 emulsified in Montanide ISA 51 VG in fusion driven sarcoma patients.
The principal questions are:
- To investigate, whether it is possible to induce a mutation-specific immune response in sarcoma patients and young adults after salvage chemotherapy
- To investigate possible side effects and toxicity of the treatment
- To gather indications if our approach has a beneficial effect on residual disease as well as event free survival (EFS) of the patients. EFS and overall survival (OS) data will be compared within this single arm study to non-vaccinated patients of a historic control cohort.
Patients will be recruited through the Society for Pediatric Oncology/Hematology (GPOH) networks Cooperative Soft Tissue Sarcoma Group (CWS) and Cooperative Ewing Sarcoma Group (CESS) and through the "Deutsches Konsortium für Translationale Krebsforschung" (DKTK) programs MASTER and INFORM as well as HEROES-AYA. For the screening phase, n=30 patients will be recruited, n=23 patients should be treated with at least one vaccine dose, with a drop-out rate we need n=21 patients for sufficient statistical power.
Primary objective is to evaluate the safety, toxicity and in vivo immunological effects of a patient-individualized peptide vaccination (IPX vaccine) in patients with primary or relapsed metastasized fusion-driven sarcoma (FDS, rhabdomyosarcoma, Ewing- and synovial sarcoma) with an age ≥ 2 to < 40 years in first or second complete remission or stable partial remission.
Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination).
- Conditions
- Ewing Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma
- Being tested
- Peptide vaccine IPX
- Keywords
- metastasized fusion-driven sarcoma, clinical study, phase I/II
- Medical subject headings
- Sarcoma, Ewing, Rhabdomyosarcoma, Sarcoma, Synovial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide vaccine IPXBiological
Peptide vaccine is a combination of
- class II peptide spanning the sarcoma-specific fusion-breakpoint (fusion-peptide)
- class-II neopeptide based on a patient-individual nonsynonymous mutation with a high immunogenicity (mutation-based neopeptide).
- control peptide derived from Survivin.
- adjuvant: toll like receptor (TLR) 1/2 ligand XS15.
| Study group | Role | What they receive |
|---|---|---|
| Peptide vaccination | Experimental | Peptides will be administered subcutaneously (s.c.) together with the novel toll like receptor (TLR) 1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant.
Three vaccinations will be applied every 28 days. Receives: Biological: Peptide vaccine IPX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of treatment
The primary composite safety/efficacy outcome of "treatment success" is defined as number of patients
- without unacceptable toxicity (any toxicity > grade 3 according to NCI-CTC) until Follow-up visit (28 ± 7 days after last vaccination) and
- with vaccination-induced response of cluster of differentiation 4+ (CD4+) and/or cluster of differentiation 8+ (CD8+) T cells to the patient-specific peptides at Follow-up visit (28 ± 7 days after last vaccination). CD4+ and CD8+ T cells will be measured by flow cytometry.
Measured: Follow-up visit at 28 +/- 7 days after last vaccination
Secondary outcomes (6)
T-cell response at follow up
Number of patients with CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide).
Measured: Beginning of trial phase until follow-up visit at 28 +/- 7 days after last vaccination
T-cell response at final follow up
Number of patients with CD8+ and/or CD4+ T-cell responses measured 2-fold above background in response to either of the two patient-specific peptides (fusion-peptide and mutation-based neopeptide).
Measured: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Event free survival
Rate of patients that survived without progression according to RECIST criteria, stratified for immune response yes/no
Measured: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Overall survival
Rate of patients that survived. stratified for immune response yes/no
Measured: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Quality of life (QoL) defined as overall quality of life in children
QoL (Quality of life) is defined as overall quality of life measured by Pediatric Quality of Life InventoryTM PedsQL (4.0). The PedsQL uses a 0 to 4 scale with 0=never and 4=almost always.
Measured: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Quality of life (QoL) defined as overall quality of life in adults
QoL (Quality of life) is defined as overall quality of life measured by European Organisation for Research and Treatment of Cancer EORTC quality of life questionnaire (QLQ) C-30 (3.0). EORTC QLQ C-30 uses a 1-4 scale with 1=not at all and 4=very much and a 1-7 scale with 1=very poor and 7=excellent.
Measured: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start19 Sep 2023
- Primary completionJun 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ewing SarcomaStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Konsortium fürTranslationale Krebsforschung (DKTK), Cooperative Ewing Sarkom Studiengruppe, Cooperative Weichteilsarkom Study Group
- Responsible party
- Sponsor
- Investigators
- Martin Ebinger, Prof. Dr., Principal investigator, University children's hospital Tübingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094101
- Sponsor's protocol ID
- 2022-002793-91
- Acronym
- PerVision
- Status last verified
- Apr 2026
- First submitted
- 25 Sep 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Phase I/II Trial of an Individualized Peptide Vaccine in Pediatric and AYA Patients With Metastasized Fusion-driven Sarcomas Following Standard Treatment
- ClinicalTrials.gov ID
- NCT06094101
- Acronym / sponsor ID
- PerVision / 2022-002793-91
- Conditions
- Ewing Sarcoma, Rhabdomyosarcoma, Synovial Sarcoma
- Keywords
- metastasized fusion-driven sarcoma, clinical study, phase I/II
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Collaborators
- Deutsches Konsortium fürTranslationale Krebsforschung (DKTK), Cooperative Ewing Sarkom Studiengruppe, Cooperative Weichteilsarkom Study Group
- Study start
- 19 Sep 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Oct 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.
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.
This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.
It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine.
Primary objective is to evaluate safety and success of treatment, the latter be defined as vaccination-induced T-cell response without unacceptable toxicity.
Detailed description
The PerVision trial utilizes an approach of a patient-individual cancer vaccine with sarcoma-specific peptides (one peptide derived from the sarcoma-specific fusion breakpoint, 'fusion-peptide', and a second peptide derived from neoantigens derived from patient-specific non-synonymous mutations with the highest prediction score, 'mutation-based neopeptide') in metastasized fusion-driven sarcoma patients determined by next generation whole exome sequencing of tumor and normal tissue as well as RNA sequencing of the tumor.
This approach is applicable to all patients independent of the expression of distinct tumor associated antigens, and independent of their human leukocyte antigen-typing (HLA-typing). The results of this study can directly be translated to other tumor entities.
It is an interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study evaluating a personalized peptide vaccine and the toll like receptor (TLR) 1/2 ligand XS15 emulsified in Montanide ISA 51 VG in fusion driven sarcoma patients.
The principal questions are:
- To investigate, whether it is possible to induce a mutation-specific immune response in sarcoma patients and young adults after salvage chemotherapy
- To investigate possible side effects and toxicity of the treatment
- To gather indications if our approach has a beneficial effect on residual disease as well as event free survival (EFS) of the patients. EFS and overall survival (OS) data will be compared within this single arm study to non-vaccinated patients of a historic control cohort.
Patients will be recruited through the Society for Pediatric Oncology/Hematology (GPOH) networks Cooperative Soft Tissue Sarcoma Group (CWS) and Cooperative Ewing Sarcoma Group (CESS) and through the "Deutsches Konsortium für Translationale Krebsforschung" (DKTK) programs MASTER and INFORM as well as HEROES-AYA. For the screening phase, n=30 patients will be recruited, n=23 patients should be treated with at least one vaccine dose, with a drop-out rate we need n=21 patients for sufficient statistical power.
Primary objective is to evaluate the safety, toxicity and in vivo immunological effects of a patient-individualized peptide vaccination (IPX vaccine) in patients with primary or relapsed metastasized fusion-driven sarcoma (FDS, rhabdomyosarcoma, Ewing- and synovial sarcoma) with an age ≥ 2 to < 40 years in first or second complete remission or stable partial remission.
Primary endpoint is "success of treatment", defined as the patient showing a vaccination-induced T cell response without unacceptable toxicity until Follow-up visit (28 ± 7 days after last vaccination).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- interventional, multicenter, open-label, phase I/II feasibility and early proof of concept study
| Arm | Type | Receives |
|---|---|---|
| Peptide vaccination | Experimental | Biological: Peptide vaccine IPXPeptides will be administered subcutaneously (s.c.) together with the novel toll like receptor (TLR) 1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant. Three vaccinations will be applied every 28 days. |
Who may qualify
- Ages
- 2 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (20 listed)
- Ejection fraction < 25%
- Creatinine-clearance < 40ml/min
- Bilirubin > 4mg/dl
- Alanine aminotransferase (ALT) > 400 units (U)/l and/or aspartate aminotransferase (AST) > 400 U/l
- Severe infection (Human immunodeficiency virus (HIV): positive for the presence of human immunodeficiency virus-1 or human immunodeficiency virus-2 (positive antigen/antibody or nucleic acid tests [NAT]) and CD4-positive cells < 500/μl. Hepatitis B virus: positive for the presence of hepatitis B virus (positive for hepatitis B core antibody [HBcAb] or positive hepatitis B surface antigen [HBsAg]) and hepatitis B NAT test > 2000 IU/ml). Hepatitis C virus: positive for heavy chain only antibody [HCAb] or for nucleic acid amplification testing (NAT). Other infections that, in the opinion of the investigator, do not allow a participation in the study.)
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 |
|---|---|---|
| Peptide vaccine IPXPeptide vaccine is a combination of 1. class II peptide spanning the sarcoma-specific fusion-breakpoint (fusion-peptide) 2. class-II neopeptide based on a patient-individual nonsynonymous mutation with a high immunogenicity (mutation-based neopeptide). 3. control peptide derived from Survivin. 4. adjuvant: toll like receptor (TLR) 1/2 ligand XS15. | Biological | Peptide vaccination |
Primary outcome
Success of treatment
Time frame: Follow-up visit at 28 +/- 7 days after last vaccination
The primary composite safety/efficacy outcome of "treatment success" is defined as number of patients 1. without unacceptable toxicity (any toxicity > grade 3 according to NCI-CTC) until Follow-up visit (28 ± 7 days after last vaccination) and 2. with vaccination-induced response of cluster of differentiation 4+ (CD4+) and/or cluster of differentiation 8+ (CD8+) T cells to the patient-specific peptides at Follow-up visit (28 ± 7 days after last vaccination). CD4+ and CD8+ T cells will be measured by flow cytometry.
6 secondary outcomes
T-cell response at follow up
Time frame: Beginning of trial phase until follow-up visit at 28 +/- 7 days after last vaccination
T-cell response at final follow up
Time frame: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Event free survival
Time frame: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Overall survival
Time frame: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Quality of life (QoL) defined as overall quality of life in children
Time frame: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Quality of life (QoL) defined as overall quality of life in adults
Time frame: Beginning of trial phase until final follow-up at 120 +/- 14 days after last vaccination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joachim Rupprecht, Dr. contact
Martin Ebinger, Prof. Dr. principal investigator
University children's hospital Tübingen
4 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 Peptide vaccine IPX in people with Ewing Sarcoma and Rhabdomyosarcoma, run by University Hospital Tuebingen at 4 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 0 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Ebinger, Prof. Dr. (+49 7071 2983781, martin.ebinger@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success of treatment (time frame: Follow-up visit at 28 +/- 7 days after last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.