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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006973 | U.S. NIH Grant/Contract | View source | |
| NA_00046066 | Other Identifier | JHMIRB |
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Loss of funding
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Vaccines made from a person's white blood cells may help the body build an effective immune response.
PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients who are being considered for solid organ transplant who are at risk for post-transplant lymphoproliferative disorder.
OBJECTIVES:
Primary
OUTLINE: This is a nonrandomized, pilot study. Patients are stratified according to Epstein-Barr virus (EBV) status (seropositive vs seronegative).
Patients receive photochemically-treated autologous EBV-transformed B-lymphoblastoid cell vaccine intradermally once in weeks 0 and 4.
After completion of study treatment, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBV Seronegative | Experimental | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline. |
|
| EBV Seropositive | Experimental | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inactivated EBV-infected vaccine | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Vaccine as Assessed by T-cell Responses | Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection. | Up to 67 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events Associated With the Vaccine | Number of participants who received at least one vaccination and experienced at least one grade 3-4 adverse event by CTCAE 2.0 that was attributed to protocol therapy. | Up to 5 years |
| Prevention of Primary Epstein-Barr Virus (EBV) Infection |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Body weight ≥ 25 kg
Karnofsky performance status 50-100% OR
Lansky performance status 50-100%
Not pregnant
Negative pregnancy test
Fertile patients must use contraception during and for 2 months after completion of study treatment
Hemoglobin ≥ 8 g/dL (erythropoietin allowed)
No history of autoimmune disease, including any of the following:
No primary immunodeficiency
No HIV positivity
PRIOR CONCURRENT THERAPY:
No corticosteroids for 1 month before and for 1 month after the first study vaccination, except for the following:
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| Name | Affiliation | Role |
|---|---|---|
| Richard F Ambinder, MD, PhD | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21231-2410 | United States |
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One subject on the EBV seronegative arm was a screen failure. One EBV seronegative subject was not assigned to intervention arm due to physician decision.
Seven EBV seropositive subjects were not assigned to intervention arm: three due to physician decision; one due to loss of follow-up; one due to death; and two due to subject withdrawal.
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| ID | Title | Description |
|---|---|---|
| FG000 | EBV Seronegative | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline. |
| FG001 | EBV Seropositive | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | EBV Seronegative | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline. Inactivated EBV-infected vaccine |
| BG001 | EBV Seropositive |
| 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 | Efficacy of Vaccine as Assessed by T-cell Responses | Percentage of participants with T-cell responses. For participants who were EBV-seronegative at enrollment, a response is defined as the appearance of EBV-specific T-cells at one month after the second injection. For participants who were EBV-seropositive at enrollment, a response is defined as a two-fold increase over baseline in the frequency of CD8+ T-cells responding to EBV latency antigens at any point during the first 67 days following the first injection. | T-cell responses were uninterpretable on lab analysis; therefore, data was not collected to assess this outcome measure. | Posted | Up to 67 days |
|
Up to 5 years
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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 | EBV Seronegative | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were negative for Epstein-Barr Virus (EBV) at baseline. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bacteremia | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ascites | Hepatobiliary disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Ambinder, MD, PhD | Johns Hopkins University | 4109558839 | rambind1@jhmi.edu |
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| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| ID | Term |
|---|---|
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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Number of participants who were EBV-seronegative at baseline, received at least one vaccination, subsequently received a solid organ transplant (not part of this protocol), and did not develop a primary EBV infection. |
| Up to 5 years |
Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline.
Inactivated EBV-infected vaccine
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | EBV Seropositive | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline. Inactivated EBV-infected vaccine |
|
| Secondary | Adverse Events Associated With the Vaccine | Number of participants who received at least one vaccination and experienced at least one grade 3-4 adverse event by CTCAE 2.0 that was attributed to protocol therapy. | Posted | Count of Participants | Participants | Up to 5 years |
|
|
|
| Secondary | Prevention of Primary Epstein-Barr Virus (EBV) Infection | Number of participants who were EBV-seronegative at baseline, received at least one vaccination, subsequently received a solid organ transplant (not part of this protocol), and did not develop a primary EBV infection. | Only one participant met the criteria described in the outcome description. This participant was never tested post-transplant for EBV, so no data was collected for this outcome measure. | Posted | Up to 5 years |
|
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| 1 |
| 2 |
| 1 |
| 2 |
| 1 |
| 2 |
| EG001 | EBV Seropositive | Inactivated EBV-infected vaccine given at Week 0 and Week 4. This arm included all participants who were positive for Epstein-Barr Virus (EBV) at baseline. | 4 | 12 | 2 | 12 | 9 | 12 |
| Peritonitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Acute lung injury | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Bruising | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Cough | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Diplopia | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Headache | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Hypertension | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Injection site reaction | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Leukopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Pain - unspecified | General disorders | CTCAE (2.0) | Systematic Assessment |
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| Pain - abdomen | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Pain - axilla | Skin and subcutaneous tissue disorders | CTCAE (2.0) | Systematic Assessment |
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| Runny nose | Respiratory, thoracic and mediastinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Sore throat | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Streptococcal pharyngitis | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
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| Thrombocytopenia | Investigations | CTCAE (2.0) | Systematic Assessment |
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| Umbilical hernia | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | CTCAE (2.0) | Systematic Assessment |
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