LeukemiaPhase 1NCT00514189
Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
A Phase 1 study testing Autologous Dendritic Cells in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary Objectives: 1. To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy. 2. To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA. 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- What is being tested?
- Autologous Dendritic Cells
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Untreated AML except patients with inv (16), t(8;21), or t (15;17) cytogenetics or AML in first relapse.
- Patients must have >/= 2,000 circulating blasts/ul peripheral blood or >/= 50% blasts in bone marrow biopsy
- Performance Status 0-2
Who cannot join
- Medical, social or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
- History of systemic autoimmune disease
- Positive antibody to human immunodeficiency virus
- Patients with Acute promyelocytic Leukemia are not eligible for this study.
- Good-risk cytogenetics which are: (inv (16), t(8;21), or t (15;17)
- Positive Beta HCG test in a woman with child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization
Trial locations and contacts
1 site in 1 country.
About this study
Primary Objectives:
- To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy.
- To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
- To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.
Secondary Objectives:
- To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
- To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.
Read the detailed description
Patient Consent: Arm 1 - Standard-Dose Consolidation
The vaccine will be made from your AML cells which will be killed, frozen, and stored away when you start the study. When you go into remission, researchers will take your normal blood cells and culture them in the laboratory until they become "dendritic cells." Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture. This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 tablespoon) will be drawn to make sure you do not have an infection with HIV/AIDS. If you do, you will not be eligible for this study.
If you are found to be eligible to take part in this study, AML cells will be collected from your blood through a vein in your arm. A blood separator device called an apheresis machine will be used. Each apheresis procedure takes about 3-5 hours. It is similar to donating platelets to a blood bank. During the procedure the blood with tumor cells will be removed and then returned through a second line in the other arm. You may have bone marrow aspirations instead with general anesthesia, usually lasting up to 3 hours. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After the AML cells are collected, you will start receiving your induction and consolidation chemotherapy treatment. This treatment is standard of care and is not directly related to your participation in this study. After your first cycle of consolidation treatment, a bone marrow biopsy will be done to find out if you are in complete remission. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. If you are in complete remission then you will have your normal blood stem cells collected, which will be used to make the vaccine. All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells. Beginning 5 days before the first collection, you will receive daily injections under the skin of granulocyte colony stimulating factor (G-CSF). These are given to increase the number of normal stem cells available for collection. On Days 5 and 6 of G-CSF treatment, your normal stem cells will be collected. They will be taken to the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After you complete the apheresis procedure to collect normal cells, you will continue consolidation therapy (typically 3-5 cycles). The vaccine will be made with your previously frozen cells. Once thawed, a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an 8-day procedure.
After the last consolidation cycle, you will begin to receive 4 monthly injections of the vaccine. The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days). Once it is ready, each vaccine will be injected into a lymph node in your groin. A special machine called a sonogram (typically used to look at babies in the womb) will be used to painlessly locate exactly where the injection should go.
About 3-7 days after each vaccine, about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine. At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine. This will be done with a small injection under the skin on your forearm. About 48 hours later, researchers will measure the area around the injection for redness, which would be a sign that your immune system is reacting to the vaccine.
After you have received all 4 vaccines, you will be seen in the clinic yearly to evaluate how you tolerated the vaccines.
Routine long-term follow-up exams will be performed by your leukemia doctor as per standard of care.
This is an investigational study. The vaccines are not commercially available and only authorized for use in research. A total of 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Patient Consent: Arm 2 - Autologous Peripheral Blood Progenitor Cell Consolidation
The vaccine will be made from your AML cells which will be killed, frozen, and stored away when you start the study. When you go into remission, researchers will take your normal blood cells and culture them in the laboratory until they become "dendritic cells." Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture. This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 tablespoon) will be drawn to make sure you do not have an infection with HIV/AIDS. If you do, you will not be eligible for this study.
If you are found to be eligible to take part in this study, AML cells will be collected from your blood through a vein in your arm. A blood separator device called an apheresis machine will be used. Each apheresis procedure takes about 3-5 hours. It is similar to donating platelets to a blood bank. You may have bone marrow aspirations instead with general anesthesia, usually lasting up to 3 hours. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After the AML cells are collected, you will start receiving your induction and consolidation chemotherapy treatment. This treatment is standard of care and is not directly related to your participation in this study. After your first cycle of consolidation treatment, a bone marrow biopsy will be done to find out if you are in complete remission. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. If you are in complete remission then you will have your normal blood stem cells collected, which will be used to make the vaccine. All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells. Beginning 5 days before the first collection, you will receive daily injections under the skin of granulocyte colony stimulating factor (G-CSF). These are given to increase the number of normal stem cells available for collection. On Days 5 and 6 of G-CSF treatment, your normal stem cells will be collected. They will be taken to the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After you complete the apheresis procedure to collect normal cells, you will continue consolidation therapy with high-dose standard busulfan and cyclophosphamide chemotherapy. You will also have an autologous peripheral blood progenitor cell transplant. The chemotherapy and transplant are standard of care.
After the chemotherapy and transplant when your blood counts have recovered, you will begin to receive 4 monthly injections of the vaccine. The vaccine will be made with your previously frozen cells. Once thawed, a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an eight day procedure.
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days). Once it is ready, each vaccine will be injected into a lymph node in your groin. A special machine called a sonogram (typically used to look at babies in the womb) will be used to painlessly locate exactly where the injection should go.
About 3-7 days after each vaccine, about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine. At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine. This will be done with a small injection under the skin on your forearm. About 48 hours later, researchers will measure the area around the injection for redness, which would be a sign that your immune system is reacting to the vaccine.
After you have received all 4 vaccines, you will be seen in the clinic to evaluate how you tolerated the vaccines.
Routine long-term follow-up exams will be performed by your leukemia doctor yearly as per standard of care.
This is an investigational study. The vaccines are not commercially available and only authorized for use in research. A total of 20 patients take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Leukemia
- Being tested
- Autologous Dendritic Cells
- Keywords
- Acute Myelogenous Leukemia, Leukemia, Autologous Dendritic Cells, Vaccine, AML, mRNA
- Medical subject headings
- Leukemia, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Dendritic CellsBiological
Also called DCs
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days).
| Study group | Role | What they receive |
|---|---|---|
| Autologous Dendritic Cells | Experimental | Not described Receives: Biological: Autologous Dendritic Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Adverse Event (AE)
Measured: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Why it stopped: Terminated early due to slow accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Chitra M. Hosing, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514189
- Sponsor's protocol ID
- 2005-0379
- Status last verified
- Jul 2012
- First submitted
- 8 Aug 2007
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Acute Myelogenous Leukemia mRNA Plus Lysate Loaded Dendritic Cell Vaccines
- ClinicalTrials.gov ID
- NCT00514189
- Acronym / sponsor ID
- 2005-0379
- Conditions
- Leukemia
- Keywords
- Acute Myelogenous Leukemia, Leukemia, Autologous Dendritic Cells, Vaccine, AML, mRNA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated early due to slow accrual.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Aug 2007 (estimated)
- 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.
Primary Objectives:
- To determine the feasibility of delivering autologous dendritic cells (DCs) loaded with acute myelogenous leukemia (AML) lysate plus messenger RNA (mRNA) to AML patients following consolidation therapy.
- To determine the toxicity of autologous DCs loaded with AML lysate plus mRNA.
- To quantitate immune responses in patients who receive autologous DCs loaded with AML lysate plus mRNA.
Secondary Objectives:
- To evaluate minimal residual disease following DC therapy using the polymerase chain reaction assay for the Wilm's Tumor-1 gene.
- To asses the disease-free and overall survival of AML patients who receive the autologous DCs loaded with AML lysate plus mRNA.
Detailed description
Patient Consent: Arm 1 - Standard-Dose Consolidation
The vaccine will be made from your AML cells which will be killed, frozen, and stored away when you start the study. When you go into remission, researchers will take your normal blood cells and culture them in the laboratory until they become "dendritic cells." Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture. This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 tablespoon) will be drawn to make sure you do not have an infection with HIV/AIDS. If you do, you will not be eligible for this study.
If you are found to be eligible to take part in this study, AML cells will be collected from your blood through a vein in your arm. A blood separator device called an apheresis machine will be used. Each apheresis procedure takes about 3-5 hours. It is similar to donating platelets to a blood bank. During the procedure the blood with tumor cells will be removed and then returned through a second line in the other arm. You may have bone marrow aspirations instead with general anesthesia, usually lasting up to 3 hours. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After the AML cells are collected, you will start receiving your induction and consolidation chemotherapy treatment. This treatment is standard of care and is not directly related to your participation in this study. After your first cycle of consolidation treatment, a bone marrow biopsy will be done to find out if you are in complete remission. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. If you are in complete remission then you will have your normal blood stem cells collected, which will be used to make the vaccine. All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells. Beginning 5 days before the first collection, you will receive daily injections under the skin of granulocyte colony stimulating factor (G-CSF). These are given to increase the number of normal stem cells available for collection. On Days 5 and 6 of G-CSF treatment, your normal stem cells will be collected. They will be taken to the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After you complete the apheresis procedure to collect normal cells, you will continue consolidation therapy (typically 3-5 cycles). The vaccine will be made with your previously frozen cells. Once thawed, a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an 8-day procedure.
After the last consolidation cycle, you will begin to receive 4 monthly injections of the vaccine. The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days). Once it is ready, each vaccine will be injected into a lymph node in your groin. A special machine called a sonogram (typically used to look at babies in the womb) will be used to painlessly locate exactly where the injection should go.
About 3-7 days after each vaccine, about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine. At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine. This will be done with a small injection under the skin on your forearm. About 48 hours later, researchers will measure the area around the injection for redness, which would be a sign that your immune system is reacting to the vaccine.
After you have received all 4 vaccines, you will be seen in the clinic yearly to evaluate how you tolerated the vaccines.
Routine long-term follow-up exams will be performed by your leukemia doctor as per standard of care.
This is an investigational study. The vaccines are not commercially available and only authorized for use in research. A total of 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Patient Consent: Arm 2 - Autologous Peripheral Blood Progenitor Cell Consolidation
The vaccine will be made from your AML cells which will be killed, frozen, and stored away when you start the study. When you go into remission, researchers will take your normal blood cells and culture them in the laboratory until they become "dendritic cells." Researchers will then thaw your tumor cells and load parts of them into the dendritic cells and inject the mixture. This type of vaccine will hopefully encourage your immune system to prevent later relapse of your disease.
Before you can start treatment on this study, you will have what are called "screening tests." These tests will help the doctor decide if you are eligible to take part in this study. Blood (about 1 tablespoon) will be drawn to make sure you do not have an infection with HIV/AIDS. If you do, you will not be eligible for this study.
If you are found to be eligible to take part in this study, AML cells will be collected from your blood through a vein in your arm. A blood separator device called an apheresis machine will be used. Each apheresis procedure takes about 3-5 hours. It is similar to donating platelets to a blood bank. You may have bone marrow aspirations instead with general anesthesia, usually lasting up to 3 hours. To collect a bone marrow aspirate, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow is withdrawn through a large needle. The AML cells collected by either the apheresis or bone marrow collection procedure will be used later to make the vaccine in the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After the AML cells are collected, you will start receiving your induction and consolidation chemotherapy treatment. This treatment is standard of care and is not directly related to your participation in this study. After your first cycle of consolidation treatment, a bone marrow biopsy will be done to find out if you are in complete remission. To collect a bone marrow biopsy, an area of the hip or chest bone is numbed with anesthetic, and a small amount of bone marrow and bone is withdrawn through a large needle. If you are in complete remission then you will have your normal blood stem cells collected, which will be used to make the vaccine. All of the normal stem cells will be collected with the same apheresis machine used to collect tumor cells. Beginning 5 days before the first collection, you will receive daily injections under the skin of granulocyte colony stimulating factor (G-CSF). These are given to increase the number of normal stem cells available for collection. On Days 5 and 6 of G-CSF treatment, your normal stem cells will be collected. They will be taken to the M. D. Anderson Cell Therapy Laboratory where they will be frozen and stored until it is time to make the vaccine.
After you complete the apheresis procedure to collect normal cells, you will continue consolidation therapy with high-dose standard busulfan and cyclophosphamide chemotherapy. You will also have an autologous peripheral blood progenitor cell transplant. The chemotherapy and transplant are standard of care.
After the chemotherapy and transplant when your blood counts have recovered, you will begin to receive 4 monthly injections of the vaccine. The vaccine will be made with your previously frozen cells. Once thawed, a machine called the CliniMACS will be used to isolate the cells from your blood that will be grown into the vaccine during an eight day procedure.
The first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days). Once it is ready, each vaccine will be injected into a lymph node in your groin. A special machine called a sonogram (typically used to look at babies in the womb) will be used to painlessly locate exactly where the injection should go.
About 3-7 days after each vaccine, about 4 tablespoons of your blood will be drawn to measure the immune reaction to the vaccine. At that time you will also have a skin test performed to look for the presence or absence of an immune reaction to the vaccine. This will be done with a small injection under the skin on your forearm. About 48 hours later, researchers will measure the area around the injection for redness, which would be a sign that your immune system is reacting to the vaccine.
After you have received all 4 vaccines, you will be seen in the clinic to evaluate how you tolerated the vaccines.
Routine long-term follow-up exams will be performed by your leukemia doctor yearly as per standard of care.
This is an investigational study. The vaccines are not commercially available and only authorized for use in research. A total of 20 patients take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous Dendritic Cells | Experimental | Biological: Autologous Dendritic Cells |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Untreated AML except patients with inv (16), t(8;21), or t (15;17) cytogenetics or AML in first relapse.
- Patients must have >/= 2,000 circulating blasts/ul peripheral blood or >/= 50% blasts in bone marrow biopsy
- Performance Status 0-2
Key exclusion criteria (7 listed)
- Medical, social or psychological factors which would prevent the patient from receiving or cooperating with the full course of therapy or understanding the informed consent procedure.
- Concurrent or expected need for therapy with corticosteroids during the vaccination phase of the study.
- History of systemic autoimmune disease
- Positive antibody to human immunodeficiency virus
- Patients with Acute promyelocytic Leukemia are not eligible for this 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 |
|---|---|---|
| Autologous Dendritic CellsAlso: DCsThe first vaccination will be given once your blood counts have recovered from the final dose of chemotherapy. The remaining 3 vaccinations will be given every 28 days (+/- 7 days). | Biological | Autologous Dendritic Cells |
Primary outcome
Time to Adverse Event (AE)
Time frame: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued
Results and safety
The study was stopped early (reason given: Terminated early due to slow accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
- UT MD Anderson Cancer Center websiteLink provided by the sponsor.
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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.
Chitra M. Hosing, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Autologous Dendritic Cells in people with Leukemia, run by M.D. Anderson Cancer Center at 1 site 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 3 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: stopped early, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 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.
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: Terminated early due to slow accrual.). 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?
Time to Adverse Event (AE) (time frame: Day of First Vaccination to 6 Months Follow Up After Last Patient Accrued). 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 30 Jul 2012.