Trial Outcomes & Findings for Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects (NCT NCT02040090)
NCT ID: NCT02040090
Last Updated: 2021-09-29
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
118 participants
Primary outcome timeframe
Day 14
Results posted on
2021-09-29
Participant Flow
Participant milestones
| Measure |
KamRAB
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
FDA Approved Commercially Available HRIG Product
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
|---|---|---|
|
Overall Study
STARTED
|
59
|
59
|
|
Overall Study
COMPLETED
|
56
|
57
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
KamRAB
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
FDA Approved Commercially Available HRIG Product
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
Baseline characteristics by cohort
| Measure |
KamRAB
n=59 Participants
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
HRIG Comparator Product
n=59 Participants
FDA Approved Commercially Available HRIG Product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 16.15 • n=5 Participants
|
46.3 years
STANDARD_DEVIATION 14.5 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 15.35 • n=5 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 14Outcome measures
| Measure |
KamRAB
n=56 Participants
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
HRIG Comparator Product
n=58 Participants
FDA Approved Commercially Available HRIG Product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
|---|---|---|
|
The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL
|
55 Participants
|
58 Participants
|
Adverse Events
KamRAB
Serious events: 1 serious events
Other events: 48 other events
Deaths: 0 deaths
FDA Approved Commercially Available HRIG Product
Serious events: 0 serious events
Other events: 51 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KamRAB
n=59 participants at risk
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
FDA Approved Commercially Available HRIG Product
n=59 participants at risk
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
1.7%
1/59 • Number of events 1 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
0.00%
0/59 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
Other adverse events
| Measure |
KamRAB
n=59 participants at risk
KamRAB 20 IU/kg body weight via IM injection, once on Day 0
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
FDA Approved Commercially Available HRIG Product
n=59 participants at risk
Comparator product: IM injection once on Day 0 in the same manner and at the same dosage as KamRAB.
Active rabies vaccine (US-FDA approved): A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28
|
|---|---|---|
|
Nervous system disorders
Headache
|
13.6%
8/59 • Number of events 8 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
15.3%
9/59 • Number of events 10 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
13.6%
8/59 • Number of events 9 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
13.6%
8/59 • Number of events 11 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.6%
8/59 • Number of events 8 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
10.2%
6/59 • Number of events 6 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Gastrointestinal disorders
Nausea
|
6.8%
4/59 • Number of events 4 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
3.4%
2/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Nervous system disorders
Dizziness
|
5.1%
3/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
3.4%
2/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Nervous system disorders
Presyncope
|
6.8%
4/59 • Number of events 4 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
1.7%
1/59 • Number of events 1 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.4%
2/59 • Number of events 2 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
5.1%
3/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.8%
4/59 • Number of events 4 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
0.00%
0/59 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
2/59 • Number of events 2 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
3.4%
2/59 • Number of events 2 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
General disorders
Fatigue
|
5.1%
3/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
1.7%
1/59 • Number of events 1 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Gastrointestinal disorders
Diarrhoea
|
3.4%
2/59 • Number of events 2 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
3.4%
2/59 • Number of events 2 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.1%
3/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
1.7%
1/59 • Number of events 1 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
Injury, poisoning and procedural complications
Laceration
|
3.4%
2/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
3.4%
2/59 • Number of events 3 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
|
General disorders
Injection site pain
|
49.2%
29/59 • Number of events 59 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
72.9%
43/59 • Number of events 43 • From signature of informed consent (ICF) to 185 days (post 8 half lives of product)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee agreement disclosure that restricts the right of the PI to discuss or publish trial results after the trial is completed
- Publication restrictions are in place
Restriction type: OTHER