Prostate CancerPhase 1/2NCT05617040
Prime-boost Immunotherapeutic Trial in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
A Phase 1/2 study testing ChAdOx1-PCAQ and MVA-PCAQ in people with Prostate Cancer, run by Barinthus Biotherapeutics at 7 sites in United States.
Trial summary
This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ChAdOx1-PCAQ and MVA-PCAQ
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 7 sitesUnited States
- Study dates
- 30 Jan 2023to 5 Feb 2025
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 18 years and above at the time of signing the informed consent.
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Has undergone primary therapy for prostate cancer (radical prostatectomy and/or definitive external beam radiation and/or brachytherapy). Salvage external radiation therapy (XRT) following radical prostatectomy >6 months prior to Day 1 is allowed.
- No further local therapy to prostate or systemic therapy for prostate cancer and no metastasis-directed therapy for PSA positron emission tomography (PET) positive lesions planned within 4 months after the first dose of VTP-850.
- Serum testosterone >175 ng/dL.
- Nonmetastatic (M0) disease and no evidence of prostatic bed recurrence verified by whole body bone scintigraphy and either CT or MRI. Note that a positive PSMA PET does not exclude the participant if the conventional scans are negative.
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- Serum PSA of >0.3 ng/mL for participants with prior radical prostatectomy (with or without salvage radiotherapy), or serum PSA of 2 ng/mL above nadir for participants with prior external beam radiation or brachytherapy.
- PSA doubling time ≤12 months.
- Not planning to start ADT for at least 4 months after Day 1.
- Eastern Cooperative Oncology Group (ECOG) Score 0 or 1.
- Baseline laboratory parameters must meet the following criteria:
- Haemoglobin ≥110 g/L
- White cell count ≥2.0×10^9/L
- Absolute neutrophil count ≥1.5×10^9/L
- Lymphocytes ≥0.9×10^9/L
- Platelets ≥100×10^9/L
- Creatinine ≤1.5×upper limit of normal (ULN) OR calculated creatinine clearance ≥50 mL/min by the Cockcroft Gault formula
- Total bilirubin ≤1.5×ULN, (total bilirubin >1.5×ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%)
- Alanine aminotransferase ≤1.5×ULN
- Aspartate aminotransferase ≤1.5×ULN
- Troponin T within normal range
- HbA1c <7 %
- Agrees to the following during the trial for at least 65 days after the last dose of VTP-850:
- Refrain from donating sperm PLUS, either
- Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR
- Agrees to use a male condom when having sexual intercourse with a woman of childbearing potential, and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak.
- Agrees to comply with all scheduled visits, VTP-850 administration plan, laboratory tests, lifestyle considerations and other trial procedures
Who cannot join
- Any other prior malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Unstable medical condition, drug or alcohol abuse, or medical or psychiatric condition that in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the trial requirements.
- Significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrinological, haematological or neurological disorders constituting a risk when taking the trial intervention or interfering with the interpretation of data; cardiac event or heart failure in the previous 6 months.
- Current or chronic history of liver disease. This includes but is not limited to: hepatitis virus infections, cirrhosis, drug- or alcohol-related liver disease, non alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis or any other liver disease considered clinically significant by the investigator. (Note that history of hepatitis C infection, Gilbert's syndrome or non alcoholic fatty liver not associated with steatohepatitis are not exclusions. In line with Exclusion Criterion 10, active hepatitis C infection is exclusionary.)
- Active autoimmune disease that has required systemic treatment in past 2 years with use of disease modifying agents, chronic corticosteroids (>14 days) or immunosuppressive drugs. Hormone replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
- History of severe allergy to eggs or history of severe reaction to any previous vaccination that required medical attention.
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- Medical history that could increase the participant's risk of reaction to a vaccine, including but not limited to capillary leak syndrome, transverse myelitis, multiple sclerosis, Guillain Barré syndrome, significant thrombocytopenia, thrombosis with thrombocytopenia syndrome (also termed vaccine-induced thrombotic thrombocytopenia), heparin-induced thrombocytopenia, or hereditary angioedema, acquired angioedema or idiopathic angioedema.
- Any immunocompromised state, or history of solid organ or stem cell transplantation.
- Active infection requiring parenteral antibiotic therapy or causing fever (temperature ≥38.0˚C) within 7 days prior to Day 1, or unexplained fever (temperature ≥38.0˚C) within 7 days prior to Day 1.
- Known history of infection with hepatitis B virus, or human immunodeficiency virus, or active hepatitis C virus infection (antibody and RNA positive).
- Received XRT following radical prostatectomy within 6 months prior to Day 1.
- Received ADT outside of the initial primary therapy
- Prior chemotherapy or immunotherapy (including vaccines or checkpoint inhibitors) or experimental agent or participation in a clinical trial for prostate cancer with the exception of those taking part as primary treatment option.
- Received a vaccine with adenovirus vector within 3 months prior to Day 1.
- Received any live vaccine within 30 days prior to Day 1, or planned vaccination to occur within 3 months after Day 1.
- Received any non-live/inactivated vaccine within 14 days of Day 1 or planned non-live vaccination to occur within 10 weeks after Day 1.
- Administration of immunoglobulins and/or any blood products within 28 days prior to Day 1.
- Condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days of first dose of VTP-850. Note that adrenal replacement doses are permitted. Inhaled and topical corticosteroids are allowed.
- Received an investigational product or investigational surgical procedure in the 3 months prior to Day 1 or planned use during the trial period, or participation at any time in clinical trial for prostate cancer with exception of those taking part as primary treatment.
- Any significant cardiovascular conditions per the investigator within 6 months before study entry including but not limited to: myocardial infarction, stroke, New York Heart Association class III or IV heart failure, thromboembolic events, major cardiovascular or cerebrovascular procedures, history of cardiac valvular disease or other structural heart disease or any other condition that in the investigator's opinion puts the participant at unacceptable risk to enter the study.
- Participant with QT interval corrected for heart rate (QTc) determined using Fridericia's formula (QTcF; QTcF = QT/[R-R interval {RR}^0.33]) > 470 msec and any other ECG findings deemed clinically significant at screening.
- Uncontrolled hypertension that, in the opinion of the Investigator, puts participant at increased risk of a cardiovascular event at the time of screening.
- Uncontrolled dyslipidemia that, in the opinion of the Investigator, puts participant at increased risk of cardiovascular event at the time of screening.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Virginia Health System
Charlottesville, Virginia, 22908
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Columbia University Irving Medical Center
New York, New York, 10032
Cornell University
New York, New York, 10065-4805
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer.
Read the detailed description
This is a multi-center Phase 1/2 clinical trial to evaluate safety, PSA response, and immunogenicity of the VTP850 prime-boost immunotherapeutic in men with biochemical recurrence of prostate cancer (PCa) after definitive local therapy for PCa.
VTP-850 consists of 2 components: ChAdOx1-PCAQ and MVA-PCAQ. All participants will receive ChAdOx1-PCAQ on Day 1 (prime) and MVA-PCAQ on Days 29 and 57 (boosts; Intervention Period). Participants will be followed for 6 months or until start of new therapy such as Androgen Deprivation Therapy (ADT) or until development of unequivocal metastatic PCa (Short-term Follow-up Period). Participants who have a prostate-specific antigen (PSA) response, defined as ≥50% reduction in serum PSA compared to baseline at any time, measured twice consecutively, at least 2 weeks apart, during the 6 months follow up will be followed for an additional 18 months, up to 24 months from first dose, or until start of new therapy such as ADT or development of unequivocal metastatic PCa (Long-term Follow-up Period).
Phase 1 (15-18 participants) will follow a 3+3 design to determine the recommended phase 2 regimen (RP2R; dose level of both ChAdOx1-PCAQ and MVA-PCAQ, and route of administration of MVA-PCAQ (IM or IV)) that will be used in Phase 2.
Phase 2 will consist of 2 sequential stages. In Stage 1 of Phase 2, 19 additional participants will be enrolled at the chosen Phase 2 regimen. If 4 or more of the 25 participants at the RP2R (including the Phase 1 participants who received the same dose regimen) have a PSA response, Stage 2 will be opened to enrolment of up to 100 additional participants.
- Conditions
- Prostate Cancer
- Being tested
- ChAdOx1-PCAQ, MVA-PCAQ
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChAdOx1-PCAQBiological
Recombinant nonreplicating chimpanzee adenovirus Oxford 1 (ChAdOx1) vector encoding 4 prostate cancer antigens: prostate-specific antigen (PSA), prostatic acid phosphatase (PAP), six-transmembrane epithelial antigen of prostate 1 (STEAP1), and an oncofoetal antigen (5T4).
MVA-PCAQBiological
Replication-deficient recombinant Modified Vaccinia virus Ankara (MVA) vector encoding the same prostate cancer antigens as ChAdOx1-PCAQ (prostate-specific antigen (PSA), prostatic acid phosphatase (PAP), six-transmembrane epithelial antigen of prostate 1 (STEAP1), and an oncofoetal antigen (5T4))
| Study group | Role | What they receive |
|---|---|---|
| IM/IM Low | Experimental | ChAdOx1-PCAQ 5*10^9 vp IM / MVA-PCAQ 5*10^7 pfu IM Receives: Biological: ChAdOx1-PCAQ; Biological: MVA-PCAQ |
| IM/IM Full | Experimental | ChAdOx1-PCAQ 2.5*10^10 vp IM / MVA-PCAQ 2*10^8 pfu IM Receives: Biological: ChAdOx1-PCAQ; Biological: MVA-PCAQ |
| IM/IV Full | Experimental | ChAdOx1-PCAQ 2.5*10^10 vp IM / MVA-PCAQ 2*10^7 pfu IV Receives: Biological: ChAdOx1-PCAQ; Biological: MVA-PCAQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Participants with AEs, ≥Grade 3 AEs, and serious adverse events.
Measured: From the start of the first VTP-850 administration continuing until Month 6
Secondary outcomes (1)
The PSA Response Rate to VTP-850
Percentage of participants with ≥50% reduction in serum PSA compared to baseline (2 consecutive measurements at least 2 weeks apart)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start30 Jan 2023
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Why it stopped: The trial was discontinued following completion of the Phase 1 portion. This discontinuation was not based on safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Phase 1 will follow a 3+3 design and determine the RP2R (dose level of both ChAdOx1-PCAQ and MVA-PCAQ, and route of administration of MVA-PCAQ) that will be used in Phase 2. Phase 2 will consist of 2 sequential stages. Stage 1 will enroll 19 additional participants at the RP2R. If 4 or more participants treated at the RP2R have a PSA response, Stage 2 will be opened to enrolment of up to 100 additional participants.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barinthus Biotherapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05617040
- Sponsor's protocol ID
- PCA001
- Status last verified
- Oct 2025
- First submitted
- 1 Nov 2022
- Last updated
- 10 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/Phase 2 Trial to Evaluate Safety, Immunogenicity and PSA Response of VTP-850 Prostate Cancer Immunotherapeutic in Men With Biochemical Recurrence After Definitive Local Therapy for Prostate Cancer
- ClinicalTrials.gov ID
- NCT05617040
- Acronym / sponsor ID
- PCA001
- Conditions
- Prostate Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The trial was discontinued following completion of the Phase 1 portion. This discontinuation was not based on safety concerns.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Barinthus BiotherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 15 Nov 2022 (actual)
- Results
- Posted 10 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, Phase 1/2, open-label clinical trial of the VTP-850 prime-boost immunotherapeutic in men with biochemical recurrence after definitive local therapy for prostate cancer.
Detailed description
This is a multi-center Phase 1/2 clinical trial to evaluate safety, PSA response, and immunogenicity of the VTP850 prime-boost immunotherapeutic in men with biochemical recurrence of prostate cancer (PCa) after definitive local therapy for PCa.
VTP-850 consists of 2 components: ChAdOx1-PCAQ and MVA-PCAQ. All participants will receive ChAdOx1-PCAQ on Day 1 (prime) and MVA-PCAQ on Days 29 and 57 (boosts; Intervention Period). Participants will be followed for 6 months or until start of new therapy such as Androgen Deprivation Therapy (ADT) or until development of unequivocal metastatic PCa (Short-term Follow-up Period). Participants who have a prostate-specific antigen (PSA) response, defined as ≥50% reduction in serum PSA compared to baseline at any time, measured twice consecutively, at least 2 weeks apart, during the 6 months follow up will be followed for an additional 18 months, up to 24 months from first dose, or until start of new therapy such as ADT or development of unequivocal metastatic PCa (Long-term Follow-up Period).
Phase 1 (15-18 participants) will follow a 3+3 design to determine the recommended phase 2 regimen (RP2R; dose level of both ChAdOx1-PCAQ and MVA-PCAQ, and route of administration of MVA-PCAQ (IM or IV)) that will be used in Phase 2.
Phase 2 will consist of 2 sequential stages. In Stage 1 of Phase 2, 19 additional participants will be enrolled at the chosen Phase 2 regimen. If 4 or more of the 25 participants at the RP2R (including the Phase 1 participants who received the same dose regimen) have a PSA response, Stage 2 will be opened to enrolment of up to 100 additional participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1 will follow a 3+3 design and determine the RP2R (dose level of both ChAdOx1-PCAQ and MVA-PCAQ, and route of administration of MVA-PCAQ) that will be used in Phase 2. Phase 2 will consist of 2 sequential stages. Stage 1 will enroll 19 additional participants at the RP2R. If 4 or more participants treated at the RP2R have a PSA response, Stage 2 will be opened to enrolment of up to 100 additional participants.
| Arm | Type | Receives |
|---|---|---|
| IM/IM Low | Experimental | Biological: ChAdOx1-PCAQ, Biological: MVA-PCAQChAdOx1-PCAQ 5*10^9 vp IM / MVA-PCAQ 5*10^7 pfu IM |
| IM/IM Full | Experimental | Biological: ChAdOx1-PCAQ, Biological: MVA-PCAQChAdOx1-PCAQ 2.5*10^10 vp IM / MVA-PCAQ 2*10^8 pfu IM |
| IM/IV Full | Experimental | Biological: ChAdOx1-PCAQ, Biological: MVA-PCAQChAdOx1-PCAQ 2.5*10^10 vp IM / MVA-PCAQ 2*10^7 pfu IV |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Males aged 18 years and above at the time of signing the informed consent.
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- Has undergone primary therapy for prostate cancer (radical prostatectomy and/or definitive external beam radiation and/or brachytherapy). Salvage external radiation therapy (XRT) following radical prostatectomy >6 months prior to Day 1 is allowed.
- No further local therapy to prostate or systemic therapy for prostate cancer and no metastasis-directed therapy for PSA positron emission tomography (PET) positive lesions planned within 4 months after the first dose of VTP-850.
- Serum testosterone >175 ng/dL.
Key exclusion criteria (23 listed)
- Any other prior malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years.
- Unstable medical condition, drug or alcohol abuse, or medical or psychiatric condition that in the opinion of the investigator would affect the safety of the participant or the evaluation of the data or interfere with adherence to the trial requirements.
- Significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrinological, haematological or neurological disorders constituting a risk when taking the trial intervention or interfering with the interpretation of data; cardiac event or heart failure in the previous 6 months.
- Current or chronic history of liver disease. This includes but is not limited to: hepatitis virus infections, cirrhosis, drug- or alcohol-related liver disease, non alcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis or any other liver disease considered clinically significant by the investigator. (Note that history of hepatitis C infection, Gilbert's syndrome or non alcoholic fatty liver not associated with steatohepatitis are not exclusions. In line with Exclusion Criterion 10, active hepatitis C infection is exclusionary.)
- Active autoimmune disease that has required systemic treatment in past 2 years with use of disease modifying agents, chronic corticosteroids (>14 days) or immunosuppressive drugs. Hormone replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is allowed.
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 |
|---|---|---|
| ChAdOx1-PCAQRecombinant nonreplicating chimpanzee adenovirus Oxford 1 (ChAdOx1) vector encoding 4 prostate cancer antigens: prostate-specific antigen (PSA), prostatic acid phosphatase (PAP), six-transmembrane epithelial antigen of prostate 1 (STEAP1), and an oncofoetal antigen (5T4). | Biological | IM/IM Full, IM/IM Low, IM/IV Full |
| MVA-PCAQReplication-deficient recombinant Modified Vaccinia virus Ankara (MVA) vector encoding the same prostate cancer antigens as ChAdOx1-PCAQ (prostate-specific antigen (PSA), prostatic acid phosphatase (PAP), six-transmembrane epithelial antigen of prostate 1 (STEAP1), and an oncofoetal antigen (5T4)) | Biological | IM/IM Full, IM/IM Low, IM/IV Full |
Primary outcome
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R)
Time frame: From the start of the first VTP-850 administration continuing until Month 6
Participants with AEs, ≥Grade 3 AEs, and serious adverse events.
1 secondary outcome
The PSA Response Rate to VTP-850
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 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 ChAdOx1-PCAQ and MVA-PCAQ in people with Prostate Cancer, run by Barinthus Biotherapeutics at 7 sites in United States.
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 27 inclusion and 23 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: stopped early, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. 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?
Yes. Results are posted in the registry (first posted 10 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Safety of VTP-850 Prime-boost Regimens, With the Booster Dose Administered Either IM or IV, and the Recommended Phase 2 Regimen (RP2R) (time frame: From the start of the first VTP-850 administration continuing until Month 6). 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 10 Nov 2025.