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Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects

Sponsor
Bio Products Laboratory (Other)
Overall Status
Completed
CT.gov ID
NCT03264157
Collaborator
(none)
162
Enrollment
2
Locations
2
Arms
7.1
Actual Duration (Months)
81
Patients Per Site
11.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A prospective, randomized, blinded, parallel-group, non-inferiority, phase II/III study of the safety and effectiveness of simulated post-exposure prophylaxis with BPL HRIG with co-administration of active rabies vaccine in healthy subjects.

Condition or Disease Intervention/Treatment Phase
Phase 2/Phase 3

Detailed Description

Each subject will undergo a total of 9 visits. Subjects' eligibility will be assessed at Screening, which can occur up to 28 days prior to dosing. Following a repeat eligibility check at Day 0, eligible subjects will be randomized and dosed with the randomized treatment (BPL HRIG + vaccine or Comparator HRIG + vaccine) on Day 0. Further assessments will be conducted on Days 3, 5, 7, 14, 28, 49 and the end of study assessment on Day 140. Vaccine will be administered on Day 0, 3, 7, 14 and 28.

Study Design

Study Type:
Interventional
Actual Enrollment :
162 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Treatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccineTreatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccine
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind study
Primary Purpose:
Treatment
Official Title:
A Prospective, Randomized, Double-Blind Parallel-group, Non-inferiority Phase II/III Study of the Safety and Effectiveness of BPL HRIG With Co Administration of Active Rabies Vaccine in Healthy Subjects
Actual Study Start Date :
Dec 8, 2017
Actual Primary Completion Date :
Mar 2, 2018
Actual Study Completion Date :
Jul 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: BPL HRIG + RabAvert

20 IU/kg dose HRIG + active rabies vaccine

Drug: HRIG
A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.

Biological: RabAvert
A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
Other Names:
  • active rabies vaccine

    		•
    Active Comparator: Comparator HyperRab + RabAvert

    20 IU/kg dose HRIG + active rabies vaccine

    Drug: HyperRAB
    A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
    Other Names:
  • HRIG

    • Biological: RabAvert
    A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
    Other Names:
  • active rabies vaccine

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL [Day 14]

      Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%.

    Secondary Outcome Measures

    1. Analysis of AUC0-7d [Day 0 to Day 7]

      The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.

    2. RVNA Geometric Mean Titers at Days 3, 5, 7 and 14 [Days 3, 5, 7 and 14]

      Comparison of the geometric mean titers (GMTs) for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine. The median peak RVNA titer occurred at Day 14, which is reflected in the analysis. The RVNA titer to peak geometric mean is analyzed using a repeated measures analysis. The inferential test compares RVNA values between BPL HRIG and HyperRab in a single analysis across all visits at or below the visit at which peak titer is observed. The geometric mean values presented represent a mean across all visits from baseline through and including Day 14.

    3. Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit [Days 3, 5, 7, 14, 28, 49, and 140]

      The proportion of subjects reaching antirabies antibody titer of ≥ 0.5 IU/mL after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.

    4. Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit [Days 3, 5, 7, 14, 28, 49, and 140]

      The proportion of subjects reaching antirabies antibody titer of ≥ LLOQ of the assay at each visit after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.

    5. RVNA Geometric Mean Titers at Days 14, 28, 49 and 140 [Days 14, 28, 49 and 140]

      Comparison of the GMTs for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine to assess the inhibitory effects of BPL HRIG on active immunization relative to that of the comparator HRIG.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Able and willing to sign an informed consent form.

    2. Healthy male or female subjects aged 18 - 75 years inclusive.

    3. No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.

    4. No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.

    5. No significant abnormalities in ECG according to the Investigator's judgment.

    6. Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) who are (or become) sexually active must agree to practice contraception by using a highly effective (>98%) method for the duration of the study.

    7. Females of child-bearing potential (defined from the onset of menstruation to one-year post- menopause and not surgically sterilized) must have a negative result on a serum at screening visit and a urine HCG-based pregnancy test at Day 0.

    Exclusion Criteria

    1. Female subjects who are pregnant and/or lactating.

    2. History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.

    3. Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day 0.

    4. History of anaphylactic or anaphylactoid hypersensitivity reactions to chicken egg; history of mild allergic reactions to chicken egg, e.g., skin rash only, is not an exclusion criterion

    5. History of hypersensitivity reaction to any of the following components of active rabies vaccine (US-FDA approved) e.g.: neomycin, bovine gelatin, trace amounts of chicken protein, chlortetracycline, and amphotericin B and in accordance with the product insert of the vaccine.

    6. History of life-threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.

    7. History of life-threatening allergy to blood or blood products.

    8. Fever at the time of the start of the injection (oral temperature >38ºC.) or acute illness at the time of the start of the injection. Subjects with fever on Day 0 may have entry to the study re-scheduled.

    9. History of or ongoing bleeding disorder.

    10. Previous organ transplant recipient.

    11. Ongoing immunosuppressive illness.

    12. Clinically significant illnesses including: cardiac, hepatic, renal, endocrine, neurological, hematological, neoplastic, immunological, skeletal or other) that in the opinion of the investigator, could interfere with the safety, compliance or other aspects of this study.

    13. All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer, in- situ cervical carcinoma must be in remission for a minimum of 5 years prior to Day 0. For non-melanoma skin cancers and carcinoma in-situ of the cervix may be enrolled if treated and cured at the time of screening.

    14. Evidence of active systemic infection that requires treatment with antibiotics within 2 weeks prior to Day 0.

    15. Currently receiving or have received within the past 6 months (prior to Day 0):

    • immunosuppressive drugs

    • immunomodulatory drugs

    1. Currently receiving or have received oral or IV steroids within 14 days (prior to DAY
    1. or expected to require oral or IV steroids during the study.

    1. Evidence of uncontrolled hypertension (systolic blood pressure of >150 mmHg, and/or diastolic blood pressure of >100 mmHg).

    2. Heart rate >120/min.

    3. Weight > 95.5 kg

    4. History of IgA deficiency.

    5. Is positive for any of the following at screening: serological test for HIV 1&2, HCV or HBsAg.

    6. Presence of psychiatric disorder, other mental disorder or any other medical disorder which might impair the subject's ability to give informed consent or to comply with the requirements of the study protocol.

    7. Previous enrollment in this study.

    8. Participation in an interventional clinical trial within 30 days prior to baseline visit (Day 0).

    9. Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs in the past 2 years.

    10. Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Prism Research Saint Paul Minnesota United States 55114
    2 Wake Research Associates Raleigh North Carolina United States 27612

    Sponsors and Collaborators

    • Bio Products Laboratory

    Investigators

    • Study Director: Elizabeth Holmes, MD, Bio Products Laboratory

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Bio Products Laboratory
    ClinicalTrials.gov Identifier:
    NCT03264157
    Other Study ID Numbers:
    • RIG01
    First Posted:
    Aug 29, 2017
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Jan 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Rabies
    Vaccines

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. 20 IU/kg dose HRIG + active rabies vaccine HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
    Period Title: Overall Study
    STARTED 81 81
    COMPLETED 68 74
    NOT COMPLETED 13 7

    Baseline Characteristics

    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert Total
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. 20 IU/kg dose HRIG + active rabies vaccine HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. Total of all reporting groups
    Overall Participants 81 81 162
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    41.37
    (15.0)
    44.56
    (15.4)
    42.96
    (15.2)
    Sex: Female, Male (Count of Participants)
    Female
    56
    69.1%
    54
    66.7%
    110
    67.9%
    Male
    25
    30.9%
    27
    33.3%
    52
    32.1%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    2
    2.5%
    3
    3.7%
    5
    3.1%
    Not Hispanic or Latino
    79
    97.5%
    78
    96.3%
    157
    96.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    2
    2.5%
    2
    1.2%
    Asian
    1
    1.2%
    2
    2.5%
    3
    1.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    16
    19.8%
    15
    18.5%
    31
    19.1%
    White
    62
    76.5%
    59
    72.8%
    121
    74.7%
    More than one race
    1
    1.2%
    1
    1.2%
    2
    1.2%
    Unknown or Not Reported
    1
    1.2%
    2
    2.5%
    3
    1.9%
    Region of Enrollment (participants) [Number]
    United States
    81
    100%
    81
    100%
    162
    100%
    Weight (kg) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg]
    74.61
    (12.5)
    74.51
    (13.2)
    74.56
    (12.8)

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
    Description Non-inferiority in terms of the proportion of subjects with anti-rabies antibody titer of ≥0.5 IU/mL after study drug administration using a non-inferiority margin of 10%.
    Time Frame Day 14

    Outcome Measure Data

    Analysis Population Description
    Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. 20 IU/kg dose HRIG + active rabies vaccine HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
    Measure Participants 73 74
    Count of Participants [Participants]
    73
    90.1%
    72
    88.9%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection BPL HRIG + RabAvert, Comparator HyperRab + RabAvert
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The null hypothesis is p-p0 ≤ -0.1. The alternative hypothesis is p-p0 > -0.1, where p is the proportion of subjects with anti-rabies titer of >0.5 IU/mL at Day 14 in subjects receiving BPL HRIG + vaccine and p0 is the proportion receiving comparator HRIG + vaccine. We reject the null hypothesis at the one-sided 0.025 significance level, and conclude that p-p0 > -0.1, if the lower bound of an exact 95% binomial confidence interval exceeds -0.1.
    Statistical Test of Hypothesis p-Value 0.0006
    Comments The threshold for this test is <=0.025.
    Method Farrington and Manning test
    Comments
    Method of Estimation Estimation Parameter lower 95% CI
    Estimated Value -0.05
    Confidence Interval (1-Sided) 95%
    -0.05 to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Secondary Outcome
    Title Analysis of AUC0-7d
    Description The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.
    Time Frame Day 0 to Day 7

    Outcome Measure Data

    Analysis Population Description
    Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. 20 IU/kg dose HRIG + active rabies vaccine HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
    Measure Participants 73 74
    Geometric Mean (95% Confidence Interval) [day*IU/mL]
    1.10
    1.32
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection BPL HRIG + RabAvert, Comparator HyperRab + RabAvert
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The prespecified non inferiority margin was 20%. The lower bound of the 95% CI required should be greater than 0.8 to conclude non-inferiority.
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter lower 95% CI
    Estimated Value 0.74
    Confidence Interval (2-Sided) 95%
    0.74 to 0.94
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title RVNA Geometric Mean Titers at Days 3, 5, 7 and 14
    Description Comparison of the geometric mean titers (GMTs) for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine. The median peak RVNA titer occurred at Day 14, which is reflected in the analysis. The RVNA titer to peak geometric mean is analyzed using a repeated measures analysis. The inferential test compares RVNA values between BPL HRIG and HyperRab in a single analysis across all visits at or below the visit at which peak titer is observed. The geometric mean values presented represent a mean across all visits from baseline through and including Day 14.
    Time Frame Days 3, 5, 7 and 14

    Outcome Measure Data

    Analysis Population Description
    Secondary PK population (subjects who receive the full dose of BPL HRIG or comparator HRIG and all 5 doses of active rabies vaccine and for whom all required PK samples are taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine 20 IU/kg dose HRIG + active rabies vaccine
    Measure Participants 61 69
    Through Day 14
    0.37
    0.38
    Day 3
    0.18
    0.21
    Day 5
    0.19
    0.24
    Day 7
    0.23
    0.26
    Day 14
    12.30
    8.38
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection BPL HRIG + RabAvert, Comparator HyperRab + RabAvert
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value
    Comments
    Method
    Comments
    Method of Estimation Estimation Parameter 95% CI
    Estimated Value 0.97
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments Data analyzed as log normal. The value presented is the untransformed value of the difference between means.
    4. Secondary Outcome
    Title Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit
    Description The proportion of subjects reaching antirabies antibody titer of ≥ 0.5 IU/mL after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.
    Time Frame Days 3, 5, 7, 14, 28, 49, and 140

    Outcome Measure Data

    Analysis Population Description
    Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine 20 IU/kg dose HRIG + active rabies vaccine
    Measure Participants 73 74
    Day 0
    0
    0%
    0
    0%
    Day 3
    0
    0%
    1
    1.2%
    Day 5
    0
    0%
    1
    1.2%
    Day 7
    3
    3.7%
    2
    2.5%
    Day 14
    73
    90.1%
    72
    88.9%
    Day 28
    73
    90.1%
    73
    90.1%
    Day 49
    73
    90.1%
    72
    88.9%
    Day 140
    60
    74.1%
    65
    80.2%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection BPL HRIG + RabAvert, Comparator HyperRab + RabAvert
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.
    Statistical Test of Hypothesis p-Value 0.0006
    Comments
    Method Farrington and Manning test
    Comments
    Method of Estimation Estimation Parameter lower 95% CI
    Estimated Value -0.05
    Confidence Interval (2-Sided) 95%
    -0.05 to 0.10
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    5. Secondary Outcome
    Title Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit
    Description The proportion of subjects reaching antirabies antibody titer of ≥ LLOQ of the assay at each visit after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine.
    Time Frame Days 3, 5, 7, 14, 28, 49, and 140

    Outcome Measure Data

    Analysis Population Description
    Primary PK population (all subjects who receive the full dose of BPL HRIG or comparator HRIG and the first 3 doses of active rabies vaccine on Days 0, 3, 7 and for whom the PK sample at Day 14 is taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine 20 IU/kg dose HRIG + active rabies vaccine
    Measure Participants 73 74
    Day 0
    0
    0%
    0
    0%
    Day 3
    70
    86.4%
    73
    90.1%
    Day 5
    71
    87.7%
    74
    91.4%
    Day 7
    73
    90.1%
    74
    91.4%
    Day 14
    73
    90.1%
    74
    91.4%
    Day 28
    73
    90.1%
    74
    91.4%
    Day 49
    73
    90.1%
    72
    88.9%
    Day 140
    62
    76.5%
    71
    87.7%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection BPL HRIG + RabAvert, Comparator HyperRab + RabAvert
    Comments
    Type of Statistical Test Non-Inferiority
    Comments The same methodology was used as the primary endpoint for each visit. The statistical analysis is presenting the Day 14 data.
    Statistical Test of Hypothesis p-Value 0
    Comments
    Method Farrington and Manning test
    Comments
    Method of Estimation Estimation Parameter lower 95% CI
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    0 to 0
    Parameter Dispersion Type:
    Value:
    Estimation Comments For Day 14, all subjects achieved the endpoint (RVNA titer > LLOQ). Since the statistic to measure the performance is a proportion, the proportion is 1 and no variance is calculable.
    6. Secondary Outcome
    Title RVNA Geometric Mean Titers at Days 14, 28, 49 and 140
    Description Comparison of the GMTs for antirabies antibody titer after administration of BPL HRIG and vaccine versus comparator HRIG and vaccine to assess the inhibitory effects of BPL HRIG on active immunization relative to that of the comparator HRIG.
    Time Frame Days 14, 28, 49 and 140

    Outcome Measure Data

    Analysis Population Description
    Secondary PK population (subjects who receive the full dose of BPL HRIG or comparator HRIG and all 5 doses of active rabies vaccine and for whom all required PK samples are taken).
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine 20 IU/kg dose HRIG + active rabies vaccine
    Measure Participants 61 69
    Day 14
    12.30
    8.38
    Day 28
    10.18
    7.78
    Day 49
    10.91
    7.78
    Day 140
    2.72
    2.02

    Adverse Events

    Time Frame 20 weeks treatment
    Adverse Event Reporting Description Includes treatment emergent adverse events
    Arm/Group Title BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Arm/Group Description 20 IU/kg dose HRIG + active rabies vaccine HRIG: A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28. 20 IU/kg dose HRIG + active rabies vaccine HyperRAB: A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. RabAvert: A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
    All Cause Mortality
    BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/81 (0%) 0/81 (0%)
    Serious Adverse Events
    BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/81 (0%) 0/81 (0%)
    Other (Not Including Serious) Adverse Events
    BPL HRIG + RabAvert Comparator HyperRab + RabAvert
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 19/81 (23.5%) 19/81 (23.5%)
    General disorders
    Vaccination site pain 9/81 (11.1%) 10 2/81 (2.5%) 3
    Infections and infestations
    Upper respiratory tract infection 5/81 (6.2%) 5 7/81 (8.6%) 7
    Nervous system disorders
    Headache 5/81 (6.2%) 5 10/81 (12.3%) 12

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    Results Point of Contact

    Name/Title Head of Medical Affairs
    Organization Bio Products Laboratory
    Phone 1-844-4BPLUSA
    Email MedInfo@bpl-us.com
    Responsible Party:
    Bio Products Laboratory
    ClinicalTrials.gov Identifier:
    NCT03264157
    Other Study ID Numbers:
    • RIG01
    First Posted:
    Aug 29, 2017
    Last Update Posted:
    Feb 25, 2020
    Last Verified:
    Jan 1, 2020