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PIKA rabies vaccine

Phase 2

Rabies | Vaccine | Infectious Disease |LakeShore Biopharma Co., Ltd|Trials Updated: Nov 8, 2016

PIKA rabies vaccine development status

Highest phase Phase 2
Registered trials 2 across 1 sponsor since Jan 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment163

FDA Designations

No designations recorded

PIKA rabies vaccine clinical trials

PIKA rabies vaccine · 2 trials · 1 indication

Phase 2 1Phase 1 1
NCT02956421Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated RegimenRabies
COMPLETED126 Analytics
PHASE2COMPLETED
Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
RabiesUnlock trial analytics

Study Endpoints

Primary Endpoints

Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
42 days

Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be better than a classic course with control commercialized vaccine.

Identification of any adverse events for all the treatment groups
42 days

Assessment of safety based on the identification of any adverse events for all the treatment groups, Group A, Group B and Group C through to the end of the study at day 42.

Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection
Day 14 and Day 42

To analyze the titer level of RVNA from serum at day 14 and 42 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement

Secondary Endpoints

Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
Day 7
Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Day 7, Day 14 and Day 42
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Day 7 and Day 14
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
RABIPUR®ACTIVE_COMPARATORComparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
PIKA Rabies vaccineEXPERIMENTALPIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose)
Group AACTIVE_COMPARATORComparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Group BEXPERIMENTALPIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Group CEXPERIMENTALPIKA Rabies vaccine with an accelerated regimen Healthy volunteers received rabies vaccination intramuscularly on days 0 (2 Doses), 3 (2 Doses), and day 7 (1 Dose)

Interventions

NameTypeDescription
RABIPUR®BIOLOGICALBiological rabies vaccine
PIKA rabies vaccineBIOLOGICALBiological rabies vaccine
PIKA rabies vaccine with an accelerated regimenBIOLOGICALBiological rabies vaccine
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Eligibility Criteria

Age Range21 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Informed consent form has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures. * Never received rabies vaccine before. * Refrain from blood donation during the course of the study. * Able to attend all scheduled visits and comply wi...

Countries:Singapore
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Frequently asked questions about PIKA rabies vaccine

What is the PIKA rabies vaccine?

The PIKA rabies vaccine is an investigational vaccine being developed for the prevention of rabies. It contains the PIKA adjuvant and is administered using an accelerated regimen. It is being developed by LakeShore Biopharma Co., Ltd and has been studied in two completed clinical trials in Singapore.

What is the PIKA rabies vaccine used for?

The PIKA rabies vaccine is being developed for the prevention of rabies. It is intended for use in healthy volunteers and is administered using an accelerated regimen. It is an investigational product and has not been approved for commercial use.

Who is developing the PIKA rabies vaccine?

The PIKA rabies vaccine is being developed by LakeShore Biopharma Co., Ltd, which trades under the ticker LSB. The company has conducted clinical trials of the vaccine in Singapore.

What phase is the PIKA rabies vaccine in?

The PIKA rabies vaccine is in Phase 2 clinical development. Two trials have been completed: a Phase 1 trial and a Phase 2 trial. It is an investigational vaccine and has not been approved by the FDA or any regulatory authority.

What clinical trials is the PIKA rabies vaccine in?

The PIKA rabies vaccine has been studied in two completed clinical trials. The Phase 2 trial, NCT02956421, enrolled 126 participants and evaluated efficacy and safety with an accelerated regimen. The Phase 1 trial, NCT02657161, enrolled 37 participants and assessed safety and efficacy. Both trials were conducted in Singapore.