Trial Outcomes & Findings for A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients (NCT NCT03629080)
NCT ID: NCT03629080
Last Updated: 2023-10-26
Results Overview
Assess the number and severity of participants with adverse events and serious adverse events
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
83 participants
Primary outcome timeframe
15 Months
Results posted on
2023-10-26
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
35
|
17
|
10
|
4
|
|
Overall Study
COMPLETED
|
10
|
4
|
22
|
16
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
13
|
1
|
4
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
Baseline characteristics by cohort
| Measure |
HB-101 Vaccine Preemptive
n=12 Participants
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.
|
Placebo Preemptive
n=5 Participants
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.
|
HB-101 Vaccine Prophylactic
n=35 Participants
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.
|
Placebo Prophylactic
n=17 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=10 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=4 Participants
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.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
71 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Age, Continuous
|
47.5 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
63.6 years
STANDARD_DEVIATION 9.45 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 15.13 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 13.99 • n=4 Participants
|
49.5 years
STANDARD_DEVIATION 11.92 • n=21 Participants
|
48.3 years
STANDARD_DEVIATION 6.99 • n=10 Participants
|
48.31 years
STANDARD_DEVIATION 14.35 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
20 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
10 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
65 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
73 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: 15 MonthsPopulation: 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
Assess the number and severity of participants with adverse events and serious adverse events
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=11 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=34 Participants
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.
|
Placebo Prophylactic
n=17 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=10 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events and Serious Adverse Events
Adverse Events
|
6 Participants
|
3 Participants
|
23 Participants
|
12 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Serious Adverse Events
|
5 Participants
|
2 Participants
|
14 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events and Serious Adverse Events
Grade 3 or Higher Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 15 MonthsPopulation: 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.
Assessment of CMV neutralizing antibody titers (NTAs) at day of Transplant defined by log10 virus neutralising unit(s)
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Assessment of Humoral Immunogenicity Analyses
CMV Neut (2 Doses)
|
0.8 log10 neutralizing titers
Interval 0.6 to 1.2
|
0.6 log10 neutralizing titers
Interval 0.6 to 0.6
|
0.8 log10 neutralizing titers
Interval 0.6 to 1.8
|
0.8 log10 neutralizing titers
Interval 0.6 to 1.7
|
2.6 log10 neutralizing titers
Interval 2.5 to 2.7
|
2.5 log10 neutralizing titers
Interval 2.5 to 2.5
|
|
Assessment of Humoral Immunogenicity Analyses
CMV Neut (3 Doses)
|
1.1 log10 neutralizing titers
Interval 0.6 to 1.5
|
0.6 log10 neutralizing titers
Interval 0.6 to 0.6
|
1.4 log10 neutralizing titers
Interval 1.2 to 1.8
|
0.6 log10 neutralizing titers
Interval 0.6 to 0.6
|
2.7 log10 neutralizing titers
Interval 2.7 to 2.7
|
2.5 log10 neutralizing titers
Interval 2.2 to 2.8
|
PRIMARY outcome
Timeframe: 15 MonthsPopulation: 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.
Number of patients experiencing a local or generalized injection site reaction
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=11 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=34 Participants
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.
|
Placebo Prophylactic
n=17 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=10 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=4 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Injection Site Events.
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) monthsPopulation: Only participants having received all 3 doses are analyzed and presented.
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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=3 Participants
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.
|
Placebo Preemptive
n=1 Participants
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.
|
HB-101 Vaccine Prophylactic
n=12 Participants
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.
|
Placebo Prophylactic
n=7 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=1 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=2 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change of Oral Body Temperature.
|
-0.0 Degrees Celcius
Standard Deviation 0.4
|
-0.1 Degrees Celcius
Standard Deviation 0.0
|
0.2 Degrees Celcius
Standard Deviation 0.6
|
-0.3 Degrees Celcius
Standard Deviation 0.26
|
0.6 Degrees Celcius
Standard Deviation 0.0
|
-0.2 Degrees Celcius
Standard Deviation 0.57
|
PRIMARY outcome
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) months.Population: Only participants having received all 3 doses are analyzed and presented.
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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=4 Participants
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.
|
Placebo Preemptive
n=1 Participants
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.
|
HB-101 Vaccine Prophylactic
n=11 Participants
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.
|
Placebo Prophylactic
n=7 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=1 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=2 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change of Respiration Rate.
|
0.5 breaths/minute
Standard Deviation 5.26
|
0.0 breaths/minute
Standard Deviation 0.0
|
0.2 breaths/minute
Standard Deviation 2.56
|
-0.6 breaths/minute
Standard Deviation 2.70
|
2.0 breaths/minute
Standard Deviation 0.0
|
-4.0 breaths/minute
Standard Deviation 8.49
|
PRIMARY outcome
Timeframe: Change from Baseline to 7 days after study drug administration of Dose 3. Three (3) monthsPopulation: Only participants having received all 3 doses are analyzed and presented.
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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=4 Participants
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.
|
Placebo Preemptive
n=1 Participants
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.
|
HB-101 Vaccine Prophylactic
n=13 Participants
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.
|
Placebo Prophylactic
n=7 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=1 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=2 Participants
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.
|
|---|---|---|---|---|---|---|
|
Change of Blood Pressure.
Diastolic
|
0.5 mmHg
Standard Deviation 5.74
|
2.0 mmHg
Standard Deviation 0.0
|
2.6 mmHg
Standard Deviation 9.55
|
1.3 mmHg
Standard Deviation 6.47
|
6.0 mmHg
Standard Deviation 0.0
|
6.0 mmHg
Standard Deviation 0.0
|
|
Change of Blood Pressure.
Systolic
|
-5.5 mmHg
Standard Deviation 12.61
|
11.0 mmHg
Standard Deviation 0.0
|
5.4 mmHg
Standard Deviation 14.36
|
2.7 mmHg
Standard Deviation 19.81
|
5.0 mmHg
Standard Deviation 0.0
|
2.0 mmHg
Standard Deviation 2.83
|
PRIMARY outcome
Timeframe: 15 monthsPopulation: 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.
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
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Assessment of Cellular Immunogenicity Analyses
CMV ELISPOT gB (2 Doses)
|
78.0 SFC/10e6 PBMC
Interval 78.0 to 78.0
|
—
|
37.5 SFC/10e6 PBMC
Interval 22.0 to 53.0
|
11.0 SFC/10e6 PBMC
Interval 3.0 to 15.0
|
—
|
—
|
|
Assessment of Cellular Immunogenicity Analyses
CMV ELISPOT pp65 (2 Doses)
|
83.0 SFC/10e6 PBMC
Interval 83.0 to 83.0
|
—
|
30.7 SFC/10e6 PBMC
Interval 15.0 to 50.0
|
15.0 SFC/10e6 PBMC
Interval 15.0 to 15.0
|
—
|
—
|
|
Assessment of Cellular Immunogenicity Analyses
CMV ELISPOT pp65 (3 Doses)
|
—
|
—
|
95.3 SFC/10e6 PBMC
Interval 88.0 to 105.0
|
15.0 SFC/10e6 PBMC
Interval 15.0 to 15.0
|
4145.0 SFC/10e6 PBMC
Interval 4145.0 to 4145.0
|
3897.0 SFC/10e6 PBMC
Interval 3897.0 to 3897.0
|
|
Assessment of Cellular Immunogenicity Analyses
CMV ELISPOT gB (3 Doses)
|
—
|
—
|
59.3 SFC/10e6 PBMC
Interval 25.0 to 112.0
|
15.0 SFC/10e6 PBMC
Interval 15.0 to 15.0
|
615.0 SFC/10e6 PBMC
Interval 615.0 to 615.0
|
1840.0 SFC/10e6 PBMC
Interval 1840.0 to 1840.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: the number of participants analyzed differs from the total number of participants
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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Time to Clinically Significant CMV Infection.
CMV Infection
|
50.2 days
Standard Deviation 24.05
|
83.0 days
Standard Deviation 69.30
|
256.2 days
Standard Deviation 20.82
|
248.0 days
Standard Deviation 84.59
|
171.0 days
Standard Deviation 0.00
|
15.0 days
Standard Deviation 0.00
|
|
Time to Clinically Significant CMV Infection.
CMV Syndrome
|
66.0 days
Standard Deviation 33.94
|
—
|
277.0 days
Standard Deviation 0.00
|
—
|
—
|
—
|
|
Time to Clinically Significant CMV Infection.
CMV Disease
|
62.5 days
Standard Deviation 38.89
|
—
|
277.0 days
Standard Deviation 0.00
|
—
|
0 days
Standard Deviation 0
|
0 days
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 12 monthsMeasure 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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With CMV Viremia Requiring Anti Viral Therapy
|
5 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMeasure 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.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
The Time to CMV Viremia Requiring Anti Viral Therapy.
|
53.6 days
Standard Deviation 25.13
|
129.0 days
Standard Deviation 124.45
|
259.2 days
Standard Deviation 21.74
|
259.0 days
Standard Deviation 18.38
|
171.0 days
Standard Deviation 0.00
|
15.0 days
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: 12 monthsMeasure the number of participants requiring anti-CMV therapy (at therapeutic doses) in CMV seropositive (+) recipients awaiting kidney transplant.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants Requiring Anti-CMV Therapy
|
5 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMeasure duration (in days) of anti-CMV therapy courses (at therapeutic doses) required in CMV seropositive (+) recipients awaiting kidney transplant.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=1 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=1 Participants
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.
|
|---|---|---|---|---|---|---|
|
The Duration of Anti-CMV Therapy Courses Required.
|
154.2 days
Standard Deviation 77.43
|
89.0 days
Standard Deviation 91.92
|
87.0 days
Standard Deviation 47.17
|
72.0 days
Standard Deviation 24.04
|
198.0 days
Standard Deviation NA
No Standard Deviation when one patient analyzed.
|
20.0 days
Standard Deviation NA
No Standard Deviation when one patient analyzed.
|
SECONDARY outcome
Timeframe: Up to 12 months post transplantationAssessment of number of participants with graft failure leading to biopsy-confirmation rejection of organ post transplantation.
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=10 Participants
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.
|
Placebo Preemptive
n=4 Participants
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.
|
HB-101 Vaccine Prophylactic
n=25 Participants
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.
|
Placebo Prophylactic
n=14 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=6 Participants
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=3 Participants
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.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Organ Rejection
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 12 months post transplantationPopulation: Number of participants analyzed is based on Secondary Outcome Measure #13. Only participants with organ rejection can be analyzed for this Outcome Measure.
Measurement of time (in days) between transplantation and graft failure leading to biopsy-confirmation rejection of organ
Outcome measures
| Measure |
HB-101 Vaccine Preemptive
n=1 Participants
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.
|
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.
|
HB-101 Vaccine Prophylactic
n=3 Participants
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.
|
Placebo Prophylactic
n=1 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|---|---|
|
Time to Organ Rejection
|
59.0 days
Standard Deviation NA
Only one participant analyzed.
|
—
|
126.3 days
Standard Deviation 193.81
|
34.0 days
Standard Deviation NA
only one participant analyzed.
|
—
|
—
|
Adverse Events
HB-101 Vaccine Preemptive
Serious events: 5 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo Preemptive
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
HB-101 Vaccine Prophylactic
Serious events: 14 serious events
Other events: 22 other events
Deaths: 1 deaths
Placebo Prophylactic
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HB-101 Vaccine Preemptive
n=11 participants at risk
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.
|
Placebo Preemptive
n=4 participants at risk
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.
|
HB-101 Vaccine Prophylactic
n=34 participants at risk
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.
|
Placebo Prophylactic
n=17 participants at risk
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=10 participants at risk
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=4 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Acute Myocardial Infraction
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Agina Pectoris
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Atrial Fibrillation
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Endocrine disorders
HPT Tertiary
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
GI Disorder
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Impaired Gastric Emptying
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Immune system disorders
Kidney Transplant Rejection
|
18.2%
2/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Immune system disorders
Transplant Rejection
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
20.0%
2/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Corona Virus Infection
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
CMV Infection
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
CMV Viraemia
|
9.1%
1/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
17.6%
3/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Enterobacter Infection
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Gangrene
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Gastritis Viral
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Haematoma Infection
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
Septic Shock
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Infections and infestations
UTI
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Injury, poisoning and procedural complications
Abdominal Wound Dehiscence
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
Blood Creatinine Increased
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
AKI
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Renal Artery Thrombosis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Renal Tubular Injury
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Urinary Bladder Haemorrhage
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Vascular disorders
Deep Vein Thrombosis
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
DM Inadequate Control
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Musculoskeletal and connective tissue disorders
Neuropathic Arthropathy
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
Other adverse events
| Measure |
HB-101 Vaccine Preemptive
n=11 participants at risk
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.
|
Placebo Preemptive
n=4 participants at risk
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.
|
HB-101 Vaccine Prophylactic
n=34 participants at risk
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.
|
Placebo Prophylactic
n=17 participants at risk
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.
|
HB-101 Vaccine: CMV (+) Patients-Prophylactic Management
n=10 participants at risk
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.
|
HB-101 Vaccine: CMV (+) Patients-Preemptive Management
n=4 participants at risk
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.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
9.1%
1/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
11.8%
2/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
75.0%
3/4 • Up to 15 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Cardiac disorders
Ventricular Extrasystoles
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Constipation
|
9.1%
1/11 • Up to 15 months
|
50.0%
2/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
General disorders
Hyperthermia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
General disorders
Oedema Peripheral
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
Blood Glucose Increased
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
Blood IgA Increased
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
CMV Test Positive
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
Urine Output Decreased
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypomagesaemia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypophophataemia
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Metabolic Acidosis
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Musculoskeletal and connective tissue disorders
CKD-Mineral and Bone Disorder
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
11.8%
2/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
11.8%
2/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Nervous system disorders
Dysaesthesia
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
11.8%
2/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • Up to 15 months
|
50.0%
2/4 • Up to 15 months
|
2.9%
1/34 • Up to 15 months
|
17.6%
3/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
General disorders
Peripheral Swelling
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Investigations
Donor-Specific Antibody Present
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Calcium Deficiency
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
50.0%
2/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
9.1%
1/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
5.9%
2/34 • Up to 15 months
|
5.9%
1/17 • Up to 15 months
|
10.0%
1/10 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
|
Renal and urinary disorders
Urethral Spasm
|
0.00%
0/11 • Up to 15 months
|
0.00%
0/4 • Up to 15 months
|
0.00%
0/34 • Up to 15 months
|
0.00%
0/17 • Up to 15 months
|
0.00%
0/10 • Up to 15 months
|
25.0%
1/4 • Up to 15 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place