RabiesPhase 2/3KAMRAB-003NCT02040090
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
A Phase 2/3 study testing Active rabies vaccine (US-FDA approved) in people with Rabies, run by Kamada, Ltd. at 1 site in United States.
Trial summary
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Rabies
- What is being tested?
- Active rabies vaccine (US-FDA approved)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Aug 2014
- 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.
- Healthy male or female subjects of 18 - 75 years of age inclusive who have not previously been immunized against rabies.
- Ability to comply with completion of a home diary.
- No previous exposure to Rabies epidemic, Rabies vaccine and/or Rabies Immune globulin.
- No significant abnormalities in serum hematology, serum chemistry and serum immunogenic markers (C3, C4 and C50) according to the Principal Investigator's judgment.
- No significant abnormalities in urinalysis according to the Principal Investigator's judgment.
Show all 9Show fewer
- No significant abnormalities in ECG per investigator judgment.
- Non-pregnant, non-lactating female subjects, whose screening pregnancy test is negative and who are using contraceptive methods deemed reliable by the investigator, or who are more than 5 years post-menopausal or surgically sterilized.
- Male subjects must be using at least one effective contraceptive method before study start and throughout the entire duration of the study.
Who cannot join
- History or laboratory evidence of immunoglobulin A deficiency.
- A history of previous administration of rabies vaccine or HRIG.
- History of live virus vaccine administration, e.g., measles vaccine, within the last 3 months.
- 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 hypersensitivity reaction to any of the components in an equivalent active Rabies vaccine.
Show all 26Show fewer
- History of allergy to blood or blood products.
- History of bleeding disorders.
- Fever at the time of the start of the infusion. (Oral temperature >38ºC.)
- Clinically significant intercurrent 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.
- Evidence of active systemic infection that required treatment with antibiotics within 2 weeks of the time of drug administration.
- Evidence of uncontrolled hypertension (systolic blood pressure of >150 mm Hg, and/or diastolic blood pressure of >100 mm Hg).
- Heart rate >120/min.
- Weight > 93.75 kg
- Pregnancy and/or lactation.
- Woman of child-bearing potential not taking adequate contraception deemed reliable by the investigator.
- All types of malignancies except for basal and squamous cell (scaly or plate-like) skin cancer or situ cervical carcinoma must be in remission for a minimum of 5 years., For non-melanoma skin cancers and carcinoma in-situ of the cervix may be enrolled if treated and cured at the time of screening.
- Previous organ transplant recipient.
- Evidence of ongoing infection with Hepatitis A, C, or B, or HIV 1/2.
- 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 enrolment in this study.
- Participation in another clinical trial within 30 days prior to baseline visit.
- Evidence of alcohol abuse or history of alcohol abuse or illegal and/or legally prescribed drugs in the past 10 years.
- History of life threatening allergy, anaphylactic reaction, or systemic response to human plasma derived products.
- Known hypersensitivity to any of the ingredients or excipients of the study drugs.
- 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
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Efficacy of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) and Active Rabies Vaccine in Healthy Subjects
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.
Read the detailed description
This is a prospective, randomized, double-blind, and single period non-inferiority and safety study conducted at a single study site. Subjects were randomized into the following two groups:
Group A: KamRAB (20 IU/kg by weight [bw]) intramuscular (IM), rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM Group B: Human rabies immune globulin (HRIG) Comparator product (20 IU/kg bw) IM, rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM The primary endpoint was a dichotomous (0-1) variable, defined by reaching an anti-rabies immunoglobulin G (IgG) concentration ≥0.5 IU/mL on Day 14. The primary hypothesis was that the proportion of KamRAB + vaccine recipients with anti-rabies concentration ≥0.5 IU/mL on Day 14 would not be less than the corresponding proportion of HRIG Comparator subjects by as much as 0.1.
The safety and tolerability of the study treatments was assessed based on: vital signs and physical examination findings, electrocardiogram (ECG), laboratory findings (hematology, clinical chemistry, and urinalysis) and the occurrence of adverse events (AEs) after drug administration
- Conditions
- Rabies
- Being tested
- Active rabies vaccine (US-FDA approved)
- Medical subject headings
- Rabies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active rabies vaccine (US-FDA approved)Drug
Also called RabAvert®
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 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.
| Study group | Role | What they receive |
|---|---|---|
| KamRAB | Experimental | KamRAB 20 IU/kg body weight via IM injection, once on Day 0 Receives: Drug: Active rabies vaccine (US-FDA approved) |
| FDA approved HRIG product | Active comparator | Comparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB. Receives: Drug: Active rabies vaccine (US-FDA approved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionAug 2014
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 RabiesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamada, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Matson, M.D., Principal investigator, Prism Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040090
- Sponsor's protocol ID
- KAMRAB-003
- Acronym
- KAMRAB-003
- Status last verified
- Apr 2016
- First submitted
- 28 Nov 2013
- Last updated
- 29 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Non Inferiority, Phase II/III Study of the Safety and Efficacy of Simulated Post-Exposure Prophylaxis With Kamada Human Rabies Immune Globulin (KamRAB) and Active Rabies Vaccine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02040090
- Acronym / sponsor ID
- KAMRAB-003 / KAMRAB-003
- Conditions
- Rabies
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kamada, Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Posted 29 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to: 1. Evaluate the safety and tolerability of KamRAB in comparison with Human rabies immune globulin (HRIG) comparator product. 2. To assess whether KamRAB interferes with the development of self active antibodies when given simultaneously with active rabies vaccine, as compared to the HRIG comparator product, also given in conjunction with the active rabies vaccine.
Detailed description
This is a prospective, randomized, double-blind, and single period non-inferiority and safety study conducted at a single study site. Subjects were randomized into the following two groups:
Group A: KamRAB (20 IU/kg by weight [bw]) intramuscular (IM), rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM Group B: Human rabies immune globulin (HRIG) Comparator product (20 IU/kg bw) IM, rabies vaccine (1.0 mL; ≥2.5 IU/mL) IM The primary endpoint was a dichotomous (0-1) variable, defined by reaching an anti-rabies immunoglobulin G (IgG) concentration ≥0.5 IU/mL on Day 14. The primary hypothesis was that the proportion of KamRAB + vaccine recipients with anti-rabies concentration ≥0.5 IU/mL on Day 14 would not be less than the corresponding proportion of HRIG Comparator subjects by as much as 0.1.
The safety and tolerability of the study treatments was assessed based on: vital signs and physical examination findings, electrocardiogram (ECG), laboratory findings (hematology, clinical chemistry, and urinalysis) and the occurrence of adverse events (AEs) after drug administration
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KamRAB | Experimental | Drug: Active rabies vaccine (US-FDA approved)KamRAB 20 IU/kg body weight via IM injection, once on Day 0 |
| FDA approved HRIG product | Active comparator | Drug: Active rabies vaccine (US-FDA approved)Comparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Able and willing to sign an informed consent.
- Healthy male or female subjects of 18 - 75 years of age inclusive who have not previously been immunized against rabies.
- Ability to comply with completion of a home diary.
- No previous exposure to Rabies epidemic, Rabies vaccine and/or Rabies Immune globulin.
- No significant abnormalities in serum hematology, serum chemistry and serum immunogenic markers (C3, C4 and C50) according to the Principal Investigator's judgment.
Key exclusion criteria (26 listed)
- History or laboratory evidence of immunoglobulin A deficiency.
- A history of previous administration of rabies vaccine or HRIG.
- History of live virus vaccine administration, e.g., measles vaccine, within the last 3 months.
- 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 |
|---|---|---|
| Active rabies vaccine (US-FDA approved)Also: RabAvert®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 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG. | Drug | FDA approved HRIG product, KamRAB |
Primary outcome
The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL
Time frame: Day 14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Rabies
RecruitingPhase 4
Age-Associated Differences in Germinal Center Responses to Influenza and Rabies Vaccination in Humans
Healthy Adult Participants, Age 65 and Older
Active, not recruitingPhase 3
A Clinical Trial of Rabies Vaccine（Human Diploid Cell）for Human Use,Freeze-dried in a Population Aged 10 to 60 Years
Rabies
Active, not recruitingObservational study
Real-World Effectiveness of Zamerovimab and Mazorelvimab and Vaccine for Rabies Grade III Exposure in Nanyang
Rabies Post-exposure Prophylaxis, Rabies
RecruitingObservational study
Real World Evidence Study of SYN023 in Children Exposed to Rabies
Rabies Post-exposure Prophylaxis
Enrolling by invitationPhase 3
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
Rabies Prevention
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.
Mark Matson, M.D. principal investigator
Prism Research Inc
1 site 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 Active rabies vaccine (US-FDA approved) in people with Rabies, run by Kamada, Ltd. at 1 site 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 9 inclusion and 26 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 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 29 Sep 2021). 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?
The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 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 29 Sep 2021.