Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HB-101 vaccine · 1 trial · 2 indications
Assess the number and severity of participants with adverse events and serious adverse events
Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s)
Number of patients experiencing a local or generalized injection site reaction
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.
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.
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.
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
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| 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. |
| placebo | BIOLOGICAL | Saline will be used for placebo. |
Inclusion Criteria: Patients who meet all of the following key inclusion criteria will be eligible to participate in the study: 1. Male or female patients 18 years of age or older. 2. Patients must be eligible to undergo kidney transplantation from a living donor as per institutional standards. 3....
HB-101 vaccine is an investigational vaccine being developed for cytomegalovirus (CMV) infection. It is being studied in kidney transplant patients to evaluate its safety and immunogenicity. The vaccine is designed to prevent or reduce CMV infection, which can cause serious complications in immunocompromised individuals such as transplant recipients.
HB-101 vaccine is being developed by HOOKIPA Pharma Inc., a biopharmaceutical company. The company is listed on the stock exchange under the ticker symbol HOOK. HOOKIPA is focused on developing immunotherapies for infectious diseases and cancer.
HB-101 vaccine is currently in Phase 2 clinical development. It has completed a Phase 1 trial and a Phase 2 trial. The Phase 2 trial was conducted in kidney transplant patients with cytomegalovirus infection. The vaccine is still investigational and has not been approved by regulatory authorities.
HB-101 vaccine has been evaluated in two completed clinical trials. The first was a Phase 1 trial (NCT02798692) with 54 healthy volunteers in Belgium. The second was a Phase 2 trial (NCT03629080) with 83 kidney transplant patients across the United States, Denmark, France, Germany, Norway, and the United Kingdom.
HB-101 vaccine is designed to stimulate the immune system to produce a protective response against cytomegalovirus (CMV). It is a vaccine that aims to elicit both antibody and T-cell responses to prevent or control CMV infection. The exact mechanism involves presenting CMV antigens to the immune system to generate immunity.
HB-101 vaccine is a specific vaccine candidate for cytomegalovirus (CMV) infection. It is sometimes referred to as a CMV vaccine in clinical trial titles. However, it is not the same as other CMV vaccines in development. HB-101 is a proprietary vaccine candidate developed by HOOKIPA Pharma.