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Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen

Primary Purpose

Rabies

Status
Completed
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
RABIPUR®
PIKA rabies vaccine
Sponsored by
Yisheng Biopharma (Singapore) Pte. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rabies

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 with all trial procedures.

Exclusion Criteria:

  • For women who are pregnant and breast-feeding
  • Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine
  • History of allergies to the medicine (S), convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction
  • Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth
  • Participation in any other interventional clinical trial
  • Donation of blood within the last 2 months or who have donated plasma within the last 14 days
  • Patient with clinical signs of encephalitis
  • Recipient of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination
  • Planned participation in another clinical trial during the present trial period
  • Concomitant use or at high probability of expected concomitant use during the planned study of medication such as immune suppressants, steroids, non-study vaccine or similar substances
  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of immunoglobulins and/or any blood products within 3 months prior to the first dose of study vaccine or planned administration during the study period.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
  • Uncontrolled acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination.
  • Chronic administration of immuno-suppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
  • Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor

Sites / Locations

  • SingHealth Investigational Medicine Unit
  • Clinical Trials & Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

RABIPUR®

PIKA Rabies vaccine

Arm Description

Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14

PIKA 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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
To analyze the titer level of RVNA from serum at day 7 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement

Full Information

First Posted
November 3, 2016
Last Updated
November 6, 2016
Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02956421
Brief Title
Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Official Title
Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase II clinical study for an investigational PIKA(Polyinosinic Polycytidylic Acid Based Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA adjuvant. The primary objective of the study is to evaluate the efficacy and safety profile of the vaccine composition in healthy adult volunteers under the accelerated regimen. The secondary objective is to achieve higher seroconversion of the vaccine under accelerated regimen at Day 7.
Detailed Description
A multi-center, open labelled, randomized study in healthy naïve adult subjects. Subjects were randomly assigned to groups A (60) and B (60). Group A as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR®. Group B had received doses of the investigational PIKA rabies vaccine in an accelerated regimen. Group A followed the vaccine regimen of (1-1-1-1),one injection on days 0, 3, 7 and 14 was administered respectively. Group B received the accelerated regimen (2-2-1), two injections on both days 0 and 3 were administered in different arms; and only one injection was administered on day 7. Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and 1.0 ml of RABIPUR® for Group A after reconstitution. The route of administration is intramuscular injection, given in the deltoid region of the arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rabies

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RABIPUR®
Arm Type
Active Comparator
Arm Description
Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Arm Title
PIKA Rabies vaccine
Arm Type
Experimental
Arm Description
PIKA 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)
Intervention Type
Biological
Intervention Name(s)
RABIPUR®
Intervention Description
Biological rabies vaccine
Intervention Type
Biological
Intervention Name(s)
PIKA rabies vaccine
Other Intervention Name(s)
PIKA rabies vaccine with PIKA adjuvant
Intervention Description
Biological rabies vaccine
Primary Outcome Measure Information:
Title
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen
Description
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.
Time Frame
42 days
Title
Identification of any adverse events for all the treatment groups
Description
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.
Time Frame
42 days
Secondary Outcome Measure Information:
Title
Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.
Description
To analyze the titer level of RVNA from serum at day 7 after the first injection and with RVNA titer meeting the 0.5 IU(International units) /ml World Health Organization (WHO) requirement
Time Frame
Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 with all trial procedures. Exclusion Criteria: For women who are pregnant and breast-feeding Previous vaccination against rabies (in pre- or post-exposure regimen) with either the trial vaccine or another vaccine History of allergies to the medicine (S), convulsions, epilepsy, mental illness and brain disease and clear serious systemic reaction Known bleeding disorder or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth Participation in any other interventional clinical trial Donation of blood within the last 2 months or who have donated plasma within the last 14 days Patient with clinical signs of encephalitis Recipient of any vaccine in the 4 weeks preceding the first trial vaccination, except for influenza vaccination Planned participation in another clinical trial during the present trial period Concomitant use or at high probability of expected concomitant use during the planned study of medication such as immune suppressants, steroids, non-study vaccine or similar substances Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. Administration of immunoglobulins and/or any blood products within 3 months prior to the first dose of study vaccine or planned administration during the study period. History of allergic disease or reactions likely to be exacerbated by any component of the study vaccines. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection. Uncontrolled acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history or physical examination. Chronic administration of immuno-suppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose. Clinical Manifestation of Metabolic, blood system, lungs, heart, the gastrointestinal tract, nervous system, kidneys, urinary system, endocrine, liver disease or malignant tumor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Limin Wijaya
Organizational Affiliation
Singapore General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SingHealth Investigational Medicine Unit
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Clinical Trials & Research Unit
City
Singapore
ZIP/Postal Code
529889
Country
Singapore

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29174316
Citation
Kalimuddin S, Wijaya L, Chan YFZ, Wong AWL, Oh HML, Wang LF, Kassim JA, Zhao J, Shi Z, Low JG. A phase II randomized study to determine the safety and immunogenicity of the novel PIKA rabies vaccine containing the PIKA adjuvant using an accelerated regimen. Vaccine. 2017 Dec 18;35(51):7127-7132. doi: 10.1016/j.vaccine.2017.10.097. Epub 2017 Nov 22.
Results Reference
derived

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Efficacy and Safety of a PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen

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