A Phase 2/3 interventional study of HRIG and HyperRAB in Healthy, sponsored by Bio Products Laboratory. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Bio Products Laboratory · Phase 2/3, Interventional, and Treatment
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.
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.
Bio Products Laboratory is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Currently receiving or have received within the past 6 months (prior to Day 0):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
20 IU/kg dose HRIG + active rabies vaccine
Drug: HRIG · Biological: RabAvert
20 IU/kg dose HRIG + active rabies vaccine
Drug: HyperRAB · Biological: RabAvert
A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.
A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
Also known as: HRIG
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.
Also known as: active rabies vaccine
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%.
Time frame: Day 14
Analysis of AUC0-7d
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
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.
Time frame: 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.
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
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
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.
Time frame: Days 14, 28, 49 and 140
| Milestone | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Started | 81 | 81 |
| Completed | 68 | 74 |
| Not completed | 13 | 7 |
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%.
| Participants | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Proportion of Subjects With Anti-rabies Antibody Titer of ≥0.5 IU/mL | 73 | 72 |
The AUC0-7d for BPL HRIG and vaccine versus comparator HRIG and vaccine using a non inferiority margin of 20%.
| day*IU/mL | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Analysis of AUC0-7d | 1.10 (1.02 to 1.20) | 1.32 (1.21 to 1.44) |
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.
| IU/mL | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Through Day 14 | 0.37 (0.35 to 0.39) | 0.38 (0.36 to 0.40) |
| Day 3 | 0.18 (0.16 to 0.20) | 0.21 (0.19 to 0.24) |
| Day 5 | 0.19 (0.18 to 0.21) | 0.24 (0.21 to 0.26) |
| Day 7 | 0.23 (0.21 to 0.26) | 0.26 (0.23 to 0.29) |
| Day 14 | 12.30 (10.15 to 14.90) | 8.38 (6.54 to 10.74) |
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.
| Participants | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Day 0 | 0 | 0 |
| Day 3 | 0 | 1 |
| Day 5 | 0 | 1 |
| Day 7 | 3 | 2 |
| Day 14 | 73 | 72 |
| Day 28 | 73 | 73 |
| Day 49 | 73 | 72 |
| Day 140 | 60 | 65 |
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.
| Participants | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Day 0 | 0 | 0 |
| Day 3 | 70 | 73 |
| Day 5 | 71 | 74 |
| Day 7 | 73 | 74 |
| Day 14 | 73 | 74 |
| Day 28 | 73 | 74 |
| Day 49 | 73 | 72 |
| Day 140 | 62 | 71 |
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.
| IU/mL | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| Day 14 | 12.30 (10.15 to 14.90) | 8.38 (6.54 to 10.74) |
| Day 28 | 10.18 (8.39 to 12.34) | 7.78 (6.26 to 9.66) |
| Day 49 | 10.91 (8.94 to 13.32) | 7.78 (6.34 to 9.56) |
| Day 140 | 2.72 (2.21 to 3.34) | 2.02 (1.62 to 2.53) |
Collected over 20 weeks treatment. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BPL HRIG + RabAvert | 0/81 (0%) | 0/81 (0%) | 19/81 (23.5%) |
| Comparator HyperRab + RabAvert | 0/81 (0%) | 0/81 (0%) | 19/81 (23.5%) |
| Event | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert |
|---|---|---|
| HeadacheNervous system disorders | 5/81 | 10/81 |
| Vaccination site painGeneral disorders | 9/81 | 2/81 |
| Upper respiratory tract infectionInfections and infestations | 5/81 | 7/81 |
| Age, Continuous(years) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| Mean | 41.37 ± 15.0 | 44.56 ± 15.4 | 42.96 ± 15.2 |
| Sex: Female, Male(Participants) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| Female | 56 | 54 | 110 |
| Male | 25 | 27 | 52 |
| Ethnicity (NIH/OMB)(Participants) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 3 | 5 |
| Not Hispanic or Latino | 79 | 78 | 157 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 2 | 2 |
| Asian | 1 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 16 | 15 | 31 |
| White | 62 | 59 | 121 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 1 | 2 | 3 |
| Region of Enrollment(participants) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| United States | 81 | 81 | 162 |
| Weight(kg) | BPL HRIG + RabAvert | Comparator HyperRab + RabAvert | Total |
|---|---|---|---|
| Mean | 74.61 ± 12.5 | 74.51 ± 13.2 | 74.56 ± 12.8 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2018, 2 months.
Results were first posted in Feb 2020, 1 year 11 months after primary completion. A results delay was requested in Jul 2019.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Bio Products Laboratory