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CompletedNCT02657161Updated Jan 15, 2016

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

A Phase 1 interventional study of RABIPUR® and PIKA rabies vaccine in Rabies, sponsored by Yisheng Biopharma (Singapore) Pte. Ltd.. Completed at 1 site in Singapore. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-15.

Sponsored by Yisheng Biopharma (Singapore) Pte. Ltd. · Phase 1, Interventional, and Prevention

Phase
Phase 1
Study type
Interventional
Enrollment
37
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Rabies

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03

In context

Rabies

118 studies on the registry are indexed under Rabies; 14 are open to participants now.

This study's enrollment of 37 is below the median of 200 across 108 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Yisheng Biopharma (Singapore) Pte. Ltd. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Active comparator
    Group A

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

    Biological: RABIPUR®

  • Experimental
    Group B

    PIKA Rabies vaccine Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14

    Biological: PIKA rabies vaccine

  • Experimental
    Group C

    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)

    Biological: PIKA rabies vaccine with an accelerated regimen

Interventions

  • BiologicalRABIPUR®

    Biological rabies vaccine

  • BiologicalPIKA rabies vaccine

    Biological rabies vaccine

    Also known as: 'PIKA rabies vaccine with PIKA adjuvant

  • BiologicalPIKA rabies vaccine with an accelerated regimen

    Biological rabies vaccine

    Also known as: 'PIKA rabies vaccine with PIKA adjuvant

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 42 days

  2. 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

    Time frame: Day 14 and Day 42

Secondary outcomes

  1. 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

    Time frame: Day 7, Day 14 and Day 42

  2. 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.

    Time frame: Day 7 and Day 14

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Study locations

1 site
  • SingHealth Investigational Medicine Unit
    Singapore, 169608, Singapore
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References and documents

Publications

  • 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. PubMed 28118938 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02657161
Lead sponsor
Yisheng Biopharma (Singapore) Pte. Ltd.
Collaborators
Duke-NUS Graduate Medical School
Responsible party
Sponsor
First posted
Jan 15, 2016
Start date
Feb 2015
Primary completion
Jul 2015
Completion
Jul 2015
Last update
Jan 15, 2016

Study contacts

Limin Wijaya
principal investigator · Singapore General Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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