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| ID | Type | Description | Link |
|---|---|---|---|
| MT2010-08R | Other Identifier | Blood and Bone Marrow Transplantation Program | |
| 1007M86296 | Other Identifier | IRB, University of Minnesota |
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Lack of patients and no longer influenza vaccine season.
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Study Design:
This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving 1 Dose of Vaccine | Active Comparator | Control group participants (healthy volunteers):
and/or HSCT recipients who are greater than 60 days post transplant. |
|
| Participants Receiving 2 Doses of Vaccine | Active Comparator | Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With T-Cell Based Immune Response to Vaccine | The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded. | 8 Weeks After Vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With H3 Based Immune Response to Vaccine | The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded. | 8 Weeks After Vaccination |
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Inclusion Criteria:
Patient Population
Controls:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Verneris, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| Label | URL |
|---|---|
| Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic Transplantation | View source |
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The original study design included healthy adult volunteers in addition to the HSCT recipients; however, the protocol was modified to exclude the healthy volunteers.
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| ID | Title | Description |
|---|---|---|
| FG000 | HSCT Recipients Who Were Randomized to 1 Vaccine Dose | |
| FG001 | HSCT Recipients Who Were Randomized to 2 Vaccine Doses |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HSCT Recipients Who Were Randomized to 1 Vaccine Dose | |
| BG001 | HSCT Recipients Who Were Randomized to 2 Vaccine Doses | |
| BG002 | Total |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With T-Cell Based Immune Response to Vaccine | The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded. | One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation. | Posted | Number | Patients | 8 Weeks After Vaccination |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HSCT Recipients Who Were Randomized to 1 Vaccine Dose |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Verneris, M.D. | Masonic Cancer Center, University of Minnesota | 612-626-2961 | verneris@umn.edu |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| C055753 | Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Influenza vaccine | Biological | Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B |
|
|
| Withdrawal by Subject |
|
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| HSCT Recipients Who Were Randomized to 2 Vaccine Doses |
Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant. |
|
|
| Secondary | Number of Subjects With H3 Based Immune Response to Vaccine | The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded. | One of the 33 participants randomized to receive 1 vaccine dose died prior to the 8 week evaluation. | Posted | Number | Patients | 8 Weeks After Vaccination |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | HSCT Recipients Who Were Randomized to 2 Vaccine Doses | 0 | 32 | 0 | 32 |
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| D012141 |
| Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |