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Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant

Primary Purpose

Rabies

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
RABIPUR®
PIKA rabies vaccine
PIKA rabies vaccine with an accelerated regimen
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
  • 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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Group A

Group B

Group C

Arm Description

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

PIKA Rabies vaccine 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

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

Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Assessment of efficacy was determined by the observed immune response in subjects receiving the investigational vaccine where:Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be higher in day 7 or 14 than a classic course with control commercialized vaccine.

Full Information

First Posted
January 11, 2016
Last Updated
January 13, 2016
Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
Collaborators
Duke-NUS Graduate Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT02657161
Brief Title
Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Official Title
Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
Collaborators
Duke-NUS Graduate Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Phase I 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 was to assess the clinical safety of the vaccine composition in healthy adult volunteers. The secondary objective was to evaluate the vaccine's efficacy based on an accelerated vaccine regimen.
Detailed Description
A single-center, open label, randomized phase I study in healthy naïve adult subjects. There were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12). Group A, as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14 was administered respectively. Group C 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 Group C 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 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Arm Title
Group B
Arm Type
Experimental
Arm Description
PIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Arm Title
Group C
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
Intervention Type
Biological
Intervention Name(s)
PIKA rabies vaccine with an accelerated regimen
Other Intervention Name(s)
'PIKA rabies vaccine with PIKA adjuvant
Intervention Description
Biological rabies vaccine
Primary Outcome Measure Information:
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
Title
Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection
Description
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
Time Frame
Day 14 and Day 42
Secondary Outcome Measure Information:
Title
Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Description
Assessment of efficacy was determined by the observed immune response in subjects receiving the investigational vaccine where:Detectable specific T cell mediated immune response on day 7 or day 14 and 42
Time Frame
Day 7, Day 14 and Day 42
Title
Number of subjects in Group C who has higher RVNA titre level on Day 7 or Day 14 when compared to classic course.
Description
Evaluation of the accelerated regimen is studied to check if the levels of anti-rabies antibodies (serum RVNA titer) will be higher in day 7 or 14 than a classic course with control commercialized vaccine.
Time Frame
Day 7 and Day 14

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 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

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28118938
Citation
Wijaya L, Tham CYL, Chan YFZ, Wong AWL, Li LT, Wang LF, Bertoletti A, Low JG. An accelerated rabies vaccine schedule based on toll-like receptor 3 (TLR3) agonist PIKA adjuvant augments rabies virus specific antibody and T cell response in healthy adult volunteers. Vaccine. 2017 Feb 22;35(8):1175-1183. doi: 10.1016/j.vaccine.2016.12.031. Epub 2017 Jan 22.
Results Reference
derived

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Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant

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