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Active rabies vaccine

Phase 2

Rabies | Vaccine | Infectious Disease |Kamada Ltd.|Trials Updated: Sep 29, 2021

Active rabies vaccine target and mechanism

ModalityVaccine

Also known as Active rabies vaccine (US-FDA approved)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment118

FDA Designations

No designations recorded

Active rabies vaccine clinical trials

Active rabies vaccine · 1 trial · 1 indication

Phase 2 1
NCT02040090Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy SubjectsRabies
COMPLETED118 Analytics
PHASE2COMPLETED
Phase II/III Study of the Safety and Effectiveness of HRIG With Active Rabies Vaccine in Healthy Subjects
RabiesUnlock trial analytics

Study Endpoints

Primary Endpoints

The Difference Between KamRAB and HRIG Comparator, in the Proportions of Subjects With Serum Anti-rabies IgG Antibody Concentration ≥ 0.5 IU/mL
Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeHEALTH_SERVICES_RESEARCH

Treatment Arms

ArmTypeDescription
KamRABEXPERIMENTALKamRAB 20 IU/kg body weight via IM injection, once on Day 0
FDA approved HRIG productACTIVE_COMPARATORComparator product: Intramuscular (IM) injection once on Day 0 in the same manner and at the same dosage as KamRAB.

Interventions

NameTypeDescription
Active rabies vaccine (US-FDA approved)DRUGA 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.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 vacci...

Countries:United States
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Frequently asked questions about Active rabies vaccine

What is the Active rabies vaccine used for?

The Active rabies vaccine is used for rabies, an infectious disease. It is being developed by Kamada Ltd. as a vaccine candidate. The vaccine is intended to induce an active immune response against rabies, and it has been studied in healthy adult subjects in the United States.

Who makes the Active rabies vaccine?

The Active rabies vaccine is developed by Kamada Ltd., which trades under the ticker KMDA. Kamada is the company responsible for the clinical development of this vaccine candidate for rabies.

What phase is the Active rabies vaccine in?

The Active rabies vaccine is in Phase 2 development. It has completed one clinical trial, a Phase II/III study, and is not currently listed as having any active trials. It is an investigational vaccine and is not approved by the FDA.

What clinical trials is the Active rabies vaccine in?

The Active rabies vaccine has been studied in one completed clinical trial, NCT02040090. This was a Phase II/III randomized, double-blind, active-controlled study of the safety and effectiveness of HRIG with active rabies vaccine in healthy subjects. It enrolled 118 participants in the United States.

Is the Active rabies vaccine the same as Active rabies vaccine (US-FDA approved)?

Yes, the Active rabies vaccine is also known as Active rabies vaccine (US-FDA approved). This alternative name refers to the same vaccine candidate developed by Kamada Ltd. for rabies.