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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-005047-32 | EudraCT Number |
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HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative patients receiving a kidney transplant from a CMV-Seropositive living donor and CMV-Seropositive patients.Patients enrolled should have a living donor kidney transplantation ideally planned between two to four months after the first injection of study drug (HB-101 or placebo).
This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in adult patients awaiting kidney transplantation. For Groups 1 and 2, adult CMV-seronegative (-) patients awaiting kidney transplant from a CMV-seropositive (+) living donor will be enrolled according to treatment intent with regard to the method of CMV prevention after transplant (either preemptive or prophylactic). This will be defined at study enrollment by the investigator and institutional standards. Patients enrolled in Group 1 and 2 will be randomized to receive HB-101 or placebo. For Group 3, adult CMV-seropositive (+) patients awaiting kidney transplant from either CMV-seropositive(+) or CMV-seronegative(-) living donors will be enrolled. Group 3 will be open label where all patients will receive HB-101. The post transplant management for Group 3 patients will also follow either preemptive or prophylactic method per the institution standards. The intent of the study is to administer three doses of the study drug (HB-101 or placebo) prior to transplantation and within proximity to the time of transplantation. However, two doses of study drug will be sufficient for the patients to be included in the efficacy analyses if a third dose of study drug is not feasible due to transplantation timelines. Patients will not receive study drug after transplantation. Patients will be recruited globally from transplant centers. The total duration of the study of each patient participating in the study will be approximately 15 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HB-101 vaccine preemptive | Experimental | Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. |
|
| Placebo preemptive | Placebo Comparator | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. |
|
| HB-101 vaccine prophylactic | Experimental | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. |
|
| Placebo prophylactic | Placebo Comparator | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HB-101 vaccine | Biological | HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Serious Adverse Events | Assess the number and severity of participants with adverse events and serious adverse events | 15 Months |
| Assessment of Humoral Immunogenicity Analyses | Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s) | 15 Months |
| Number of Patients With Injection Site Events. | Number of patients experiencing a local or generalized injection site reaction | 15 Months |
| Change of Oral Body Temperature. | Oral body temperature was measured in degrees Celsius prior to study drug administrations and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. | Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months |
| Change of Respiration Rate. | Respiration rate in breaths per minute was measured prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. | Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months. |
| Change of Blood Pressure. | Diastolic and Systolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Clinically Significant CMV Infection. | Measure the time to clinically significant CMV infection, CMV disease, and CMV syndrome. Time to infection was defined as the number of days of the first quantifiable result above the LLOQ monitored for 12 months after transplantation. | 12 months |
| Number of Participants With CMV Viremia Requiring Anti Viral Therapy |
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Inclusion Criteria:
Patients who meet all of the following key inclusion criteria will be eligible to participate in the study:
Exclusion Criteria:
Patients who meet any of the following key criteria will be excluded from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Hookipa Biotech GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1917 Clinic at UAB | Birmingham | Alabama | 35205 | United States | ||
| California Institute of Renal Research |
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| ID | Title | Description |
|---|---|---|
| FG000 | HB-101 Vaccine Preemptive | Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 9, 2020 | Jun 21, 2023 |
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This phase 2 study will be conducted in three groups stratified by treatment intent. In Group 1, patients will be randomized to receive HB-101 (1a) or placebo (1b) and followed preemptively post-transplant. Approximately 50 patients will be randomized in Group 1. In Group 2, patients will be randomized to receive HB-101 (2a) or placebo (2b) before transplant. Post-transplant patients will receive 3-6 months of anti-viral prophylaxis following institutional standards. Approximately 100 patients will be randomized in Group 2. In Group 3, all patients will receive HB-101 (open label) vaccination(s) prior to their transplant surgery. Post-transplant CMV management will follow either preemptive or prophylactic care as defined at study enrollment by the investigator and institutional standards. Approximately 25 patients will be randomized in Group 3.
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The participants, investigators and care providers (study site personnel) will be blinded.
|
| HB-101 vaccine: CMV (+) patients-Prophylactic Management | Experimental | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. |
|
| HB-101 vaccine: CMV (+) patients-Preemptive Management | Experimental | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. |
|
| placebo | Biological | Saline will be used for placebo. |
|
| Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months |
| Assessment of Cellular Immunogenicity Analyses | Assessment of positive CMV IFNγ ELISPOT results for pp65 and gB defined by Spot forming cells / mio PBMC per CMV Management Strategy and Doses Before Transplant | 15 months |
Measure the number of patients with CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant. |
| 12 months |
| The Time to CMV Viremia Requiring Anti Viral Therapy. | Measure the time to CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant. | 12 months |
| Number of Participants Requiring Anti-CMV Therapy | Measure the number of participants requiring anti-CMV therapy (at therapeutic doses) in CMV seropositive (+) recipients awaiting kidney transplant. | 12 months |
| The Duration of Anti-CMV Therapy Courses Required. | Measure duration (in days) of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant. | 12 months |
| Number of Participants With Organ Rejection | Assessment of number of participants with graft failure leading to biopsy-confirmation rejection of organ post transplantation. | Up to 12 months post transplantation |
| Time to Organ Rejection | Measurement of time (in days) between transplantation and graft failure leading to biopsy-confirmation rejection of organ | Up to 12 months post transplantation |
| La Mesa |
| California |
| 92123 |
| United States |
| UC Davis Health Systems | Sacramento | California | 95817 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Indiana University/IU Health | Indianapolis | Indiana | 46202 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati (UC) - College of Medicine | Cincinnati | Ohio | 45267 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Oklahoma University | Oklahoma City | Oklahoma | 73104 | United States |
| Thomas E. Starzl Transplantation Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| South Texas Accelerated Research | Dallas | Texas | 75390 | United States |
| Swedish Medical Center | Seattle | Washington | 98104 | United States |
| Odense University Hospital | Odense | 5000 | Denmark |
| Centre Hospitalier Universitaire de Bordeaux Hôpital Pellegrin | Bordeaux | 33076 | France |
| Hopital Necker-Enfants Malades | Paris | 75743 | France |
| CHU de Toulouse - Hospital Rangueil | Toulouse | 31400 | France |
| Charite Universitatsmedizin Berlin | Berlin | 10117 | Germany |
| Universitatsklinikum Essen | Essen | 45147 | Germany |
| Oslo University Hospital | Oslo | 0424 | Norway |
| Belfast Health and Social Care Trust | Belfast | BT9 7AB | United Kingdom |
| Cardiff & Vale University Health Board | Cardiff | CF14 4XW | United Kingdom |
| St James's University Hospital | Leeds | LS9 7TF | United Kingdom |
| Leicester General Hospital | Leicester | LE5 4PW | United Kingdom |
| The Royal Free Hospital | London | NW3 2QG | United Kingdom |
| FG001 | Placebo Preemptive | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. placebo: Saline will be used for placebo. |
| FG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| FG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| FG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| FG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | HB-101 Vaccine Preemptive | Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| BG001 | Placebo Preemptive | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. placebo: Saline will be used for placebo. |
| BG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| BG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| BG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| BG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Adverse Events and Serious Adverse Events | Assess the number and severity of participants with adverse events and serious adverse events | For the safety population: In groups "HB-101 prophylactic", "Placebo prophylactic" and "placebo preemptive" each 1 subject was excluded for reason being not receiving any study drug. One patient who was randomized to HB-101, received 2 doses of placebo and as a result, this patient was included in the placebo | Posted | Count of Participants | Participants | 15 Months |
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| Primary | Assessment of Humoral Immunogenicity Analyses | Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s) | The modified intent to treat population includes all participants who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. | Posted | Mean | Full Range | log10 neutralizing titers | 15 Months |
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| Primary | Number of Patients With Injection Site Events. | Number of patients experiencing a local or generalized injection site reaction | For the safety population: In groups "HB-101 prophylactic", "Placebo prophylactic" and "placebo preemptive" each 1 subject was excluded for reason being not receiving any study drug. One patient who was randomized to HB-101, received 2 doses of placebo and as a result, this patient was included in the placebo. | Posted | Count of Participants | Participants | 15 Months |
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| Primary | Change of Oral Body Temperature. | Oral body temperature was measured in degrees Celsius prior to study drug administrations and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. | Only participants having received all 3 doses are analyzed and presented. | Posted | Mean | Standard Deviation | Degrees Celcius | Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months |
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| Primary | Change of Respiration Rate. | Respiration rate in breaths per minute was measured prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. | Only participants having received all 3 doses are analyzed and presented. | Posted | Mean | Standard Deviation | breaths/minute | Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months. |
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| Primary | Change of Blood Pressure. | Diastolic and Systolic Blood Pressure was measured in millimeters of mercury (mmHg) prior to study drug administration and seven days after. The results express the change from baseline (defined as the last measurement prior to the first dose of study drug) to Dose 3. | Only participants having received all 3 doses are analyzed and presented. | Posted | Mean | Standard Deviation | mmHg | Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months |
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| Primary | Assessment of Cellular Immunogenicity Analyses | Assessment of positive CMV IFNγ ELISPOT results for pp65 and gB defined by Spot forming cells / mio PBMC per CMV Management Strategy and Doses Before Transplant | The modified intent to treat population includes all participants who received a kidney transplant and at least 2 doses of study drug prior to kidney transplant. | Posted | Mean | Full Range | SFC/10e6 PBMC | 15 months |
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| Secondary | Time to Clinically Significant CMV Infection. | Measure the time to clinically significant CMV infection, CMV disease, and CMV syndrome. Time to infection was defined as the number of days of the first quantifiable result above the LLOQ monitored for 12 months after transplantation. | the number of participants analyzed differs from the total number of participants | Posted | Mean | Standard Deviation | days | 12 months |
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| Secondary | Number of Participants With CMV Viremia Requiring Anti Viral Therapy | Measure the number of patients with CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | The Time to CMV Viremia Requiring Anti Viral Therapy. | Measure the time to CMV viremia requiring anti viral therapy for CMV seronegative (-) recipients awaiting kidney transplantation from a CMV seropositive (+) donor and to be treated prophylactically for CMV post transplant. | Posted | Mean | Standard Deviation | days | 12 months |
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| Secondary | Number of Participants Requiring Anti-CMV Therapy | Measure the number of participants requiring anti-CMV therapy (at therapeutic doses) in CMV seropositive (+) recipients awaiting kidney transplant. | Posted | Count of Participants | Participants | 12 months |
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| Secondary | The Duration of Anti-CMV Therapy Courses Required. | Measure duration (in days) of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant. | Posted | Mean | Standard Deviation | days | 12 months |
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| Secondary | Number of Participants With Organ Rejection | Assessment of number of participants with graft failure leading to biopsy-confirmation rejection of organ post transplantation. | Posted | Count of Participants | Participants | Up to 12 months post transplantation |
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| Secondary | Time to Organ Rejection | Measurement of time (in days) between transplantation and graft failure leading to biopsy-confirmation rejection of organ | Number of participants analyzed is based on Secondary Outcome Measure #13. Only participants with organ rejection can be analyzed for this Outcome Measure. | Posted | Mean | Standard Deviation | days | Up to 12 months post transplantation |
|
Up to 15 months
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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 | HB-101 Vaccine Preemptive | Three doses of HB-101 vaccine will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. | 0 | 11 | 5 | 11 | 6 | 11 |
| EG001 | Placebo Preemptive | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post-transplant patients will be monitored per preemptive institutional standard. placebo: Saline will be used for placebo. | 0 | 4 | 2 | 4 | 3 | 4 |
| EG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. | 1 | 34 | 14 | 34 | 22 | 34 |
| EG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. | 0 | 17 | 5 | 17 | 12 | 17 |
| EG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. | 0 | 10 | 2 | 10 | 6 | 10 |
| EG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. | 0 | 4 | 2 | 4 | 3 | 4 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Leukopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute Myocardial Infraction | Cardiac disorders | Systematic Assessment |
| ||
| Agina Pectoris | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
| ||
| Cardiac Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| HPT Tertiary | Endocrine disorders | Systematic Assessment |
| ||
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| GI Disorder | Gastrointestinal disorders | Systematic Assessment |
| ||
| Impaired Gastric Emptying | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Small Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Kidney Transplant Rejection | Immune system disorders | Systematic Assessment |
| ||
| Transplant Rejection | Immune system disorders | Systematic Assessment |
| ||
| Corona Virus Infection | Infections and infestations | Systematic Assessment |
| ||
| Cystitis | Infections and infestations | Systematic Assessment |
| ||
| CMV Infection | Infections and infestations | Systematic Assessment |
| ||
| CMV Viraemia | Infections and infestations | Systematic Assessment |
| ||
| Enterobacter Infection | Infections and infestations | Systematic Assessment |
| ||
| Gangrene | Infections and infestations | Systematic Assessment |
| ||
| Gastritis Viral | Infections and infestations | Systematic Assessment |
| ||
| Gastroenteritis | Infections and infestations | Systematic Assessment |
| ||
| Haematoma Infection | Infections and infestations | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Pneumonia Viral | Infections and infestations | Systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Septic Shock | Infections and infestations | Systematic Assessment |
| ||
| UTI | Infections and infestations | Systematic Assessment |
| ||
| Urosepsis | Infections and infestations | Systematic Assessment |
| ||
| Abdominal Wound Dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Hyperglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyperkalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| AKI | Renal and urinary disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Artery Thrombosis | Renal and urinary disorders | Systematic Assessment |
| ||
| Renal Tubular Injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Bladder Haemorrhage | Renal and urinary disorders | Systematic Assessment |
| ||
| Urinary Retention | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Orthostatic Hypotension | Vascular disorders | Systematic Assessment |
| ||
| DM Inadequate Control | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Neuropathic Arthropathy | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Ventricular Extrasystoles | Cardiac disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hyperthermia | General disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Blood Glucose Increased | Investigations | Systematic Assessment |
| ||
| Blood IgA Increased | Investigations | Systematic Assessment |
| ||
| CMV Test Positive | Investigations | Systematic Assessment |
| ||
| Urine Output Decreased | Investigations | Systematic Assessment |
| ||
| Gout | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoglycaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophophataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| CKD-Mineral and Bone Disorder | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Dysaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Nocturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hypertension | Vascular disorders | Systematic Assessment |
| ||
| Hypotension | Vascular disorders | Systematic Assessment |
| ||
| Diarrhoea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peripheral Swelling | General disorders | Systematic Assessment |
| ||
| Donor-Specific Antibody Present | Investigations | Systematic Assessment |
| ||
| Calcium Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Folate Deficiency | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphataemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Muscle Spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Renal Impairment | Renal and urinary disorders | Systematic Assessment |
| ||
| Urethral Spasm | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hookipa Front Desk | Hookipa Biotech GmbH | +43 1 890 63 60 0 | office@hookipapharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 26, 2022 | Jun 22, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Serious Adverse Events |
|
| Grade 3 or Higher Adverse Events |
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| HB-101 Vaccine Prophylactic |
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| HB-101 Vaccine Prophylactic |
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| HB-101 Vaccine Prophylactic |
Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
|
|
| OG002 | HB-101 Vaccine Prophylactic | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG003 | Placebo Prophylactic | Three doses of placebo will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of placebo will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. placebo: Saline will be used for placebo. |
| OG004 | HB-101 Vaccine: CMV (+) Patients-Prophylactic Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will receive 3-6 months anti-viral prophylaxis following institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
| OG005 | HB-101 Vaccine: CMV (+) Patients-Preemptive Management | Three doses of HB-101 will be administered prior to transplantation and within proximity to the time of transplantation. However, two doses of HB-101 will be sufficient for the patients to be included in the efficacy analyses if an administration of the third dose is not feasible due to transplantation timelines. Post- transplant patients will follow pre-emptive management per institutional standard. HB-101 vaccine: HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV. |
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