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Glioblastoma MultiformePhase 1/2NCT03382977

Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects

A Phase 1/2 study testing VBI-1901, Carmustine and Lomustine in people with Glioblastoma Multiforme, run by VBI Vaccines Inc. at 12 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma Multiforme
What is being tested?
VBI-1901, Carmustine and Lomustine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
12 sitesUnited States
Study dates
6 Dec 2017to 30 Aug 2025
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-70 years of age
  • Histologically confirmed WHO grade IV glioblastoma
  • Unequivocal evidence of a tumor recurrence (any number of recurrences) or progression after an initial treatment regimen (prior to enrollment on this study) as assessed by MRI of the brain with and without contrast within 30 days prior to the initiation of injections of VBI-1901. An initial therapy requires surgery and radiation therapy, with or without temozolomide. In addition, alternate therapy (with or instead of temozolomide) is permitted as part of initial therapy.
  • Recovery from the effects of surgery.
  • Corticosteroid (dexamethasone or equivalent) dosage ≤ 4mg daily that has been stable or decreasing for at least 5 days.
  • Recovery from prior therapy toxicity defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
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  • Karnofsky performance status (KPS) score ≥ 70%.
  • Adequate organ function, including the following:
  • Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL
  • Serum creatinine < 1.5 × the upper limit of normal (ULN)
  • Bilirubin < 1.5 × ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN
  • Women of childbearing potential: negative urine pregnancy test within 14 days prior to the start of VBI-1901 treatment.
  • Female subjects of childbearing potential and sexually active male subjects must agree to use an acceptable form of contraception for heterosexual activity (i.e., oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for >30 days before Screening, during the study, and for 60 days after the last dose of study drug).
  • Female subjects without childbearing potential (spontaneous amenorrhea for > 12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction.
  • Able and willing to comply with protocol requirements in the opinion of the Investigator, including being able to have an MRI.
  • Written consent has been obtained.
  • Tumor specimen available for central pathological review.
  • 18-70 years of age.
  • Histologically confirmed WHO grade IV glioblastoma.
  • Unequivocal evidence of a first tumor recurrence with measurable disease, of an area no greater than 400 mm2, which may include patients with resected first recurrence tumor after an initial treatment regimen (prior to enrollment on this study) consisting of surgical intervention (tumor resection) and radiation, with or without temozolomide chemotherapy (depending on the MGMT methylation status), as assessed by MRI of the brain with and without contrast within 30 days prior to the initiation of injections of VBI-1901. In addition, alternate chemotherapy (with or instead of temozolomide) is permitted as part of initial therapy.
  • At least 12 weeks since radiotherapy treatment and/or 23 days after chemotherapy prior to first dose of VBI-1901.
  • Recovery from the effects of surgery.
  • Corticosteroid (dexamethasone or equivalent) dosage ≤ 4mg daily that has been stable or decreasing for at least 5 days.
  • Recovery from prior therapy toxicity, defined as resolution of all treatment-related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
  • Karnofsky performance status (KPS) score ≥ 70%.
  • Adequate organ function, including the following:
  • Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL; absolute lymphocyte count ≥ 500/uL;
  • Serum creatinine < 1.5 × the upper limit of normal (ULN);
  • Bilirubin < 1.5 × ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
  • Women of childbearing potential must have a negative urine pregnancy test within 14 days prior to the start of VBI-1901 treatment.
  • Female subjects of childbearing potential and sexually active male subjects must agree to use an acceptable form of contraception for heterosexual activity (i.e., oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 30 days before Screening, during the study, and for 60 days after the last dose of study drug).
  • Female subjects without childbearing potential (spontaneous amenorrhea for > 12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction.
  • Able and willing to comply with protocol requirements, in the opinion of the Investigator.
  • Written consent has been obtained.
  • Tumor specimen available for central pathological review.
  • 18 years of age or older (no age upper limit).
  • Histologically confirmed supratentorial 2016 WHO classification grade IV Glioblastoma, IDH-wildtype or grade 4 in the 2021 WHO classification. Tumors that are histologically lower grade but are classified as glioblastoma using the WHO 2021 criteria because of molecular alterations (TERT promoter mutation and/or EGFR amplification and/or combined chromosome 7 gain/10 loss) are not eligible.
  • Unequivocal evidence of a first tumor recurrence with measurable disease of an area no greater than 600 mm2, which may include patients with resected first recurrence tumor, after an initial treatment regimen (prior to enrollment on this study) consisting of surgical intervention (tumor resection) and radiation, with or without temozolomide chemotherapy (depending on the MGMT methylation status), as assessed by MRI of the brain with and without contrast completed within 30 days prior to screening visit, if not it should be performed as part of screening visit. In addition, alternate bio/chemotherapy (with or instead of temozolomide) other than nitrosourea is permitted as part of initial therapy.
  • At least 12 weeks since radiotherapy treatment and/or 23 days after chemotherapy prior to first dose of VBI-1901 or SOC treatment. Patients with recurrent GBM within 12 weeks of radiation therapy may be included if they have surgically proven tumor recurrence (i.e.
  • this is proven to not be pseudoprogression).
  • Recovery from the effects of surgery.
  • Corticosteroid (dexamethasone or equivalent) dosage ≤ 2 mg daily that has been stable for at least 5 days before randomization into the study.
  • Recovery from prior therapy toxicity, defined as resolution of all treatment related adverse events (AEs) to Grade ≤ 1 or pre-treatment baseline (except alopecia).
  • Karnofsky performance status (KPS) score ≥70%.
  • Adequate organ function, including the following:
  • Absolute neutrophil count (ANC) ≥ 1,000/μL, platelets ≥ 100,000/μL; Absolute lymphocyte count ≥ 500/uL; CD4/CD8 ratio ≥1 or CD4 count ≥ 400/uL;
  • Serum creatinine < 1.5 × the upper limit of normal (ULN);
  • Bilirubin < 1.5 × ULN;
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 × ULN.
  • Women of childbearing potential must have a negative urine pregnancy test within 21 days prior to the start of treatment.
  • Female subjects of childbearing potential and sexually active male subjects must agree to use an acceptable form of contraception for heterosexual activity (i.e., oral contraceptives, double barrier methods, hormonal injectable, transdermal, or implanted contraceptives, tubal ligation, or vasectomy of their sexual partner(s) for > 40 days before Screening, during the study, and for 60 days after the last dose of study drug).
  • Female subjects without childbearing potential (spontaneous amenorrhea for >12 months or surgically sterilized by tubal ligation, hysterectomy, or bilateral oophorectomy > 6 months before Screening) are eligible for inclusion without contraceptive use restriction.
  • Able and willing to comply with protocol requirements, in the opinion of the Investigator.
  • Written consent has been obtained.

Who cannot join

  • Contrast-enhancing residual tumor that is associated with either diffuse sub-ependymal or leptomeningeal dissemination.
  • Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of VBI-1901 treatment.
  • Evidence of HCMV viremia in serum of > 18,200 (4.3Log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).
  • Surgical resection or major surgical procedure within 4 days prior to the start of VBI-1901, or stereotactic biopsy within 7 days prior to the start of VBI-1901.
  • Active infection requiring intravenous antibiotics or antiviral.
  • History of cancer (other than GBM or prostate) within the past 2 years that could negatively impact survival and/or potentially confound tumor response assessments within this study.
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  • Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.
  • Evidence of intra-tumoral or peri-tumoral hemorrhage on baseline, other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans.
  • Any condition which in the investigator's opinion makes the subject unsuitable for study participation.
  • Lack of family or social support structure that would preclude continued participation in the study.
  • PART B OPTIMAL DOSE
  • Contrast-enhancing residual tumor that is any of the following:
  • An area greater than 400mm2;
  • Multi-focal (defined as two separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T2 sequences);
  • Associated with either diffuse sub-ependymal or leptomeningeal dissemination.
  • IDH1/2 has been proven to be mutated by IHC or PCR or if recurrent GBM was previously a lower grade glioma and wildtype IDH1/2 status has not been confirmed.
  • Requirement of systemic corticosteroid therapy > 4 mg/day of dexamethasone or equivalent or requirement of increasing dose of systemic corticosteroids during the 7 days prior to the start of VBI-1901 treatment.
  • Evidence of HCMV viremia in plasma of >18,200 (4.3log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche).
  • Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic vaccination, or biologics (e.g. monoclonal antibodies, such as bevacizumab) presumed to have immunomodulatory effects.
  • Surgical resection or major surgical procedure within 14 days prior to the start of VBI-1901, or stereotactic biopsy within 14 days prior to the start of VBI-1901.
  • Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convection- enhanced delivery administered agents, etc.
  • Concurrent therapy with Optune® or use within 1 week of start of treatment with VBI-1901.
  • Active infection requiring intravenous antibiotics or antivirals.
  • History of cancer (other than GBM or prostate) within the past 2 years that has metastatic or local recurrence potential and could negatively impact survival and/or potentially confound tumor response assessments within this study.
  • Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Immunosuppressive agent within 4 weeks prior to the start of VBI-1901 treatment.
  • Any severe adverse event or allergy suspected or attributed to the shingles vaccines that contains AS01B components.
  • Evidence of intra- or peri-tumoral hemorrhage on baseline MRI scan, other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans.
  • Any condition which in the investigator's opinion makes the subject unsuitable for study participation.
  • Lack of family or social support structure that would preclude continued participation in the study.
  • PART C RANDOMIZED OPEN-LABEL STUDY EXTENSION
  • Contrast-enhancing residual tumor that is any of the following:
  • An area greater than 600 mm2;
  • Multicentric (defined as two separate areas of contrast enhancement measuring at least 1 cm in 2 planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T2 sequences);
  • Associated with either diffuse sub-ependymal or leptomeningeal dissemination.
  • If recurrent GBM was previously a lower grade glioma and wildtype IDH1/2 status has not been confirmed.
  • Requirement of systemic corticosteroid therapy > 2 mg/day of dexamethasone or equivalent during the 5 days prior to the start of treatment.
  • Evidence of HCMV viremia in plasma of > 18,200 (4.3log10) IU/mL using FDA approved COBAS® AmpliPrep/COBAS® TaqMan® HCMV test (Roche) or other qualified HCMV assay.
  • Prior treatment involving immunotherapy, including oncolytic viruses, therapeutic vaccination, or biologics presumed to have immunomodulatory effects. Prior bevacizumab therapy is allowed, requiring at least 28 days washout period before randomization.
  • Surgical resection or major surgical procedure within 14 days prior to the start of treatment, or stereotactic biopsy within 7 days prior to the start of treatment.
  • Radiation therapy, local therapy (except for surgical re-resection), or systemic therapy following first recurrence/progressive disease. Excluded local therapies include stereotactic radiation boost, implantation of carmustine biodegradable wafers (Gliadel), intratumoral or convectionenhanced delivery administered agents, etc.
  • More than 1 (one) line of prior chemotherapy (as an example, temozolomide given with radiotherapy and after radiotherapy before recurrence is considered a single line).
  • Concurrent therapy with Optune® or use within 1 week of start of treatment. Previous use of Optune® in the primary setting does not preclude participation in this clinical trial.
  • Active infection requiring intravenous antibiotics or antivirals.
  • History of cancer (other than GBM or prostate) within the past 2 years that has metastatic or local recurrence potential and could negatively impact survival and/or potentially confound tumor response assessments within this study.
  • Known immunosuppressive disease or active systemic autoimmune disease such as systemic lupus erythematosus, human immunodeficiency virus infection, Hepatitis B virus or Hepatitis C virus infections. Subjects with vitiligo, type 1 diabetes mellitus, hypothyroidism due to autoimmune condition only requiring hormone replacement therapy, psoriasis not requiring systemic therapy, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
  • Any known allergies to the ingredients of VBI-1901 or GM-CSF or carmustine or lomustine.
  • Evidence of intra- or peri-tumoral hemorrhage on baseline MRI scan, other than those that are ≤Grade 1 and either post-operative or stable on at least 2 consecutive MRI scans.
  • Any medical or social condition which in the investigator's opinion makes the subject unsuitable for study participation. For instance, lack of family or social support structure that would preclude continued participation in the study.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • University of California, Irvine

    Irvine, California, 92868

  • University of California, San Diego

    La Jolla, California, 92093

  • University of California, Los Angeles Neuro-Oncology Program

    Los Angeles, California, 90095

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • The Neurological Institute of New York Columbia University Medical Center

    New York, New York, 10032

  • The Valley Hospital - Neurosurgeons of New Jersey

    Ridgewood, New Jersey, 07450

  • Providence - Swedish Medical Center

    Seattle, Washington, 98122

  • Stanford

    Stanford, California, 94305

Other trials in United States

About this study

Official title: A Three-part, Phase I/II Dose-Escalation Study to Define the Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 With Subsequent Extension of Optimal Dose in Recurrent GBM Subjects

The purpose of this study is to assess the safety and tolerability of VBI-1901 in subjects with recurrent malignant gliomas (glioblastoma, or GBM).

Read the detailed description

This is a three-part, dose-escalation study to define the safety, tolerability, and optimal dose level of candidate GBM vaccine VBI-1901 with subsequent extension of optimal dose level in recurrent GBM subjects and comparison with standard of care (SOC) treatment. Subjects in groups receiving VBI-1901 vaccination will continue to receive vaccine every 4 weeks until tumor progression per immunotherapy Response Assessment for Neuro-Oncology (iRANO)/Response Assessment for Neuro-Oncology (RANO) criteria.

Being tested
VBI-1901, Carmustine, Lomustine
Keywords
GBM, Glioblastoma, eVLP, VBI-1901, vaccine, immunotherapy, CMV, CNS, Brain, Cancer
Medical subject headings
Glioblastoma, Neoplasms

What participants receive

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

  • VBI-1901Biological

    The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.

  • CarmustineDrug

    Also called BiCNU

    Treatment with carmustine intravenously at a dose of 150 mg/m² on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.

  • LomustineDrug

    Also called Gleostine

    Treatment with lomustine given orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg) on Day 1 and every 6 weeks until the earlier of disease progression or intolerable toxicity.

Study groups in NCT03382977
Study groupRoleWhat they receive
Part A Dose Level 1ExperimentalVBI-1901 low dose (0.4 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections
Receives: Biological: VBI-1901
Part A Dose Level 2ExperimentalVBI-1901 intermediate dose (2 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections
Receives: Biological: VBI-1901
Part A Dose Level 3ExperimentalVBI-1901 high dose (10 μg pp65 content) vaccine formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal intradermal injections
Receives: Biological: VBI-1901
Part B GM-CSF AdjuvantExperimentalVBI-1901 10 μg HCMV pp65 formulated with GM-CSF (200 μg) in 0.2 to 0.4 mL volume, given in two to four equal ID injections.
Receives: Biological: VBI-1901
Part B AS01B AdjuvantExperimentalVBI-1901 10 μg HCMV pp65 formulated with AS01B (50 μg of QS-21 and 50 μg of MPL per dose) in 1.0 mL volume, given in one IM injection
Receives: Biological: VBI-1901
Part C VBI-1901 with GM-CSF AdjuvantExperimentalVBI-1901 10 μg HCMV pp65 formulated with GM-CSF (200 μg) in 0.2 mL volume, given in two equal ID injections.
Receives: Biological: VBI-1901
Part C Standard of Care TreatmentActive comparatorSingle-agent standard-of-care (SOC) treatment with either carmustine intravenously at a dose of 150 mg/m² or lomustine orally at a dose of 110 mg/m² (up to a maximum dose of 200 mg).
Receives: Drug: Carmustine; Drug: Lomustine

What is being measured

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

  1. Dose limiting toxicity (DLT) occurring during Part A of the study

    Measured: Through 14 days after each study vaccination

  2. Occurrence of AEs during each treatment cycle

    Measured: Through 28 days after each study vaccination

Secondary outcomes (9)

  1. Serum antibody immune response

    Assessment of IgG antibody to HCMV gB antigen by ELISA

    Measured: Baseline and 2 weeks after each dose of vaccine in Part A and Part B and every 3 months in Part C

  2. Cellular immune responses

    Assessment of IFN-γ and IL-5 positive peripheral blood mononuclear cells by ELISPOT

    Measured: Baseline and 2 weeks after each dose of vaccine in Part A and Part B and every 3 months in Part C

  3. Progression free survival (PFS)

    Progression free survival (PFS) from date of first dose to date of progression (per iRANO/RANO criteria) or death, as well as at 6, 12, 18 and 24 months.

    Measured: From the date of first dose to date of progression or death, as well as at 6, 12, 18 and 24 months

  4. Overall survival (OS)

    Measured: 6, 12, 18 and 24 months from date of first dose

  5. Median overall survival in Part A and Part B of the study

    Measured: Date of first dose to date of death from any cause, assessed up to 18 months

  6. Reduction in steroid use compared to baseline

    Measured: Baseline to study completion, an average of 12 months

  7. Change in quality of life (QOL questionnaire) compared to baseline

    Measured: Baseline to study completion, an average of 12 months

  8. Tumor response rates (TRR) in Part C of the study

    Complete response rate, partial response rate, progressive disease and stable disease

    Measured: Baseline to study completion, an average of 12 months

  9. Safety and efficacy of VBI-1901 compared to standard of care (SOC) in Part C of study

    An integrated analysis of safety and efficacy (OS, TRR, PFS) in subjects receiving VBI-1901 at 10 µg dose formulated with GM-CSF as compared to subjects receiving SOC

    Measured: Baseline to study completion, an average of 12 months

Timeline

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

  1. First posted26 Dec 2017
  2. Study start6 Dec 2017
  3. Primary completion30 Jul 2025
  4. Study completion30 Aug 2025

Why it stopped: VBI Bankruptcy

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+ 3 Dose Escalation Therapeutic Vaccine: VBI-1901 The vaccine is formulated with GM-CSF adjuvant and administered intradermally (ID) or with AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03382977
Sponsor's protocol ID
VBI-1901-01
Status last verified
May 2026
First submitted
23 Nov 2017
Last updated
8 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing VBI-1901, Carmustine and Lomustine in people with Glioblastoma Multiforme, run by VBI Vaccines Inc. at 12 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 56 inclusion and 50 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 8 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 12 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?

The study was stopped early (reason given: VBI Bankruptcy). Results are not available in the source record.

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?

Dose limiting toxicity (DLT) occurring during Part A of the study (time frame: Through 14 days after each 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 NCT03382977.

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 8 May 2026.

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