Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as HB-101 vaccine
Low dose HB-101 · 2 trials · 3 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
Local solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: administration site pain, induration, erythema, pruritus and swelling
General solicited symptoms will be assessed by diary card and scripted questions for 7 days after each administration: malaise, fatigue, body temperature (measured axillary), generalized myalgia.
Unsolicited AEs will be recorded through open-ended general inquiries
SAEs and pregnancies will be recorded during the whole study
Vital signs (blood pressure, heart rate and body temperature)
general evaluation based on the Investigator judgment and local evaluation of the administration site
Complete blood count
Comprehensive Metabolic Panel
| 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. |
| Low dose HB-101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a low dose of HB-101 |
| Medium dose HB-101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a middle dose of HB-101. |
| High dose HB101 group | ACTIVE_COMPARATOR | Intervention:Three administrations of a high dose of HB-101. |
| Placebo group | PLACEBO_COMPARATOR | Intervention:Three administrations of placebo (diluent) |
| 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. |
| Low dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
| Medium dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
| High dose HB-101 | BIOLOGICAL | Three intra muscular administrations at Day 0, Month 1 and Month 3 |
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....
Low dose HB-101 is an investigational vaccine being developed for the prevention of cytomegalovirus (CMV) infection. It has been studied in kidney transplant patients, a population at elevated risk from CMV, and in healthy adult volunteers. It is not an approved product and remains in clinical development.
Low dose HB-101 is developed by HOOKIPA Pharma Inc., which trades on the Nasdaq under the ticker HOOK. The company is the sponsor of the clinical program evaluating the vaccine in cytomegalovirus infection.
Low dose HB-101 is in Phase 2 development. A Phase 2 trial in kidney transplant patients has been completed, and an earlier Phase 1 trial in healthy volunteers has also been completed. The vaccine is investigational and has not been approved by the FDA.
Low dose HB-101 has been evaluated in two completed studies: NCT03629080, a Phase 2 trial of the CMV vaccine in kidney transplant patients across the United States, Denmark, France, Germany, Norway, and the United Kingdom, and NCT02798692, a Phase 1 safety and immunogenicity trial in healthy volunteers in Belgium.
Yes. Low dose HB-101 is also referred to as the HB-101 vaccine. Both names refer to the same investigational cytomegalovirus vaccine candidate developed by HOOKIPA Pharma Inc. for the prevention of CMV infection.
The Phase 2 trial NCT03629080 was a randomized, double-blind, placebo-controlled study of the CMV vaccine in kidney transplant patients. It enrolled 83 participants aged 18 years and older of all sexes, and the study has been completed.