HealthyPhase 2/3NCT03264157
Safety and Effectiveness of BPL HRIG With Active Rabies Vaccine in Healthy Subjects
A Phase 2/3 study testing HRIG, HyperRAB and RabAvert in people with Healthy, run by Bio Products Laboratory at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- HRIG, HyperRAB and RabAvert
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Dec 2017to 13 Jul 2018
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able and willing to sign an informed consent form.
- Healthy male or female subjects aged 18 - 75 years inclusive.
- No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.
- No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.
- No significant abnormalities in ECG according to the Investigator's judgment.
- 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.
- 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.
Who cannot join
- Female subjects who are pregnant and/or lactating.
- History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.
- Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day 0.
- 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
- 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.
- History of life-threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
Show all 28Show fewer
- History of life-threatening allergy to blood or blood products.
- 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.
- History of or ongoing bleeding disorder.
- Previous organ transplant recipient.
- Ongoing immunosuppressive illness.
- 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.
- 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.
- Evidence of active systemic infection that requires treatment with antibiotics within 2 weeks prior to Day 0.
- Currently receiving or have received within the past 6 months (prior to Day 0):
- immunosuppressive drugs
- immunomodulatory drugs
- Currently receiving or have received oral or IV steroids within 14 days (prior to DAY 0) or expected to require oral or IV steroids during the study.
- Evidence of uncontrolled hypertension (systolic blood pressure of >150 mmHg, and/or diastolic blood pressure of >100 mmHg).
- Heart rate >120/min.
- Weight > 95.5 kg
- History of IgA deficiency.
- Is positive for any of the following at screening: serological test for HIV 1\&2, HCV or HBsAg.
- 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.
- Previous enrollment in this study.
- Participation in an interventional clinical trial within 30 days prior to baseline visit (Day 0).
- Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs in the past 2 years.
- Any other factor that, in the opinion of the investigator, would prevent the subject from complying with the requirements of the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wake Research Associates
Raleigh, North Carolina, 27612
Prism Research
Saint Paul, Minnesota, 55114
About this study
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
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- HRIG, HyperRAB, RabAvert
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRIGDrug
A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.
HyperRABDrug
Also called HRIG
A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
RabAvertBiological
Also called active rabies vaccine
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.
| Study group | Role | What they receive |
|---|---|---|
| BPL HRIG + RabAvert | Experimental | 20 IU/kg dose HRIG + active rabies vaccine Receives: Drug: HRIG; Biological: RabAvert |
| Comparator HyperRab + RabAvert | Active comparator | 20 IU/kg dose HRIG + active rabies vaccine Receives: Drug: HyperRAB; Biological: RabAvert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
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%.
Measured: Day 14
Secondary outcomes (5)
Analysis of AUC0-7d
The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.
Measured: Day 0 to Day 7
RVNA Geometric Mean Titers at 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.
Measured: Days 3, 5, 7 and 14
Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit
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.
Measured: Days 3, 5, 7, 14, 28, 49, and 140
Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit
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.
Measured: Days 3, 5, 7, 14, 28, 49, and 140
RVNA Geometric Mean Titers at 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.
Measured: Days 14, 28, 49 and 140
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start8 Dec 2017
- Primary completion2 Mar 2018
- Study completion13 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccine
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio Products Laboratory
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Holmes, MD, Study director, Bio Products Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264157
- Sponsor's protocol ID
- RIG01
- Status last verified
- Jan 2020
- First submitted
- 22 Aug 2017
- Last updated
- 25 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03264157
- Acronym / sponsor ID
- RIG01
- Conditions
- Healthy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Bio Products LaboratoryUniversity, hospital or other
- Study start
- 8 Dec 2017 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 13 Jul 2018 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Posted 11 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Treatment A: BPL HRIG + active rabies vaccine Treatment B: Comparator HRIG + active rabies vaccine
| Arm | Type | Receives |
|---|---|---|
| BPL HRIG + RabAvert | Experimental | Drug: HRIG, Biological: RabAvert20 IU/kg dose HRIG + active rabies vaccine |
| Comparator HyperRab + RabAvert | Active comparator | Drug: HyperRAB, Biological: RabAvert20 IU/kg dose HRIG + active rabies vaccine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Able and willing to sign an informed consent form.
- Healthy male or female subjects aged 18 - 75 years inclusive.
- No previous exposure to rabies virus, rabies vaccine and/or rabies immunoglobulin.
- No significant abnormalities in hematology, biochemistry, or urinalysis according to the Principal Investigator's judgment.
- No significant abnormalities in ECG according to the Investigator's judgment.
Key exclusion criteria (28 listed)
- Female subjects who are pregnant and/or lactating.
- History of live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the last 3 months.
- Planned live virus vaccination, e.g., measles, mumps, varicella or rubella vaccine, within the 3 months after Day 0.
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRIGA 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection. | Drug | BPL HRIG + RabAvert |
| HyperRABAlso: HRIGA 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection. | Drug | Comparator HyperRab + RabAvert |
| RabAvertAlso: active rabies vaccineA 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. | Biological | BPL HRIG + RabAvert, Comparator HyperRab + RabAvert |
Primary outcome
Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL
Time frame: 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%.
5 secondary outcomes
Analysis of AUC0-7d
Time frame: Day 0 to Day 7
RVNA Geometric Mean Titers at Days 3, 5, 7 and 14
Time frame: Days 3, 5, 7 and 14
Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ 0.5 IU/mL by Visit
Time frame: Days 3, 5, 7, 14, 28, 49, and 140
Proportion of Subjects Reaching Antirabies Antibody Titer of ≥ LLOQ of the Assay by Visit
Time frame: Days 3, 5, 7, 14, 28, 49, and 140
RVNA Geometric Mean Titers at Days 14, 28, 49 and 140
Time frame: Days 14, 28, 49 and 140
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Holmes, MD study director
Bio Products Laboratory
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing HRIG, HyperRAB and RabAvert in people with Healthy, run by Bio Products Laboratory at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2020.