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

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ClinicalTrials.gov Identifier: NCT02956421
Recruitment Status : Completed
First Posted : November 7, 2016
Last Update Posted : November 8, 2016
Sponsor:
Information provided by (Responsible Party):
Yisheng Biopharma (Singapore) Pte. Ltd.

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.

Condition or disease Intervention/treatment Phase
Rabies Biological: RABIPUR® Biological: PIKA rabies vaccine Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase II Study to Determine the Efficacy and Safety of PIKA Rabies Vaccine Containing the PIKA Adjuvant With an Accelerated Regimen
Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arm Intervention/treatment
Active Comparator: RABIPUR®
Comparator vaccine RABIPUR® Healthy volunteers received rabies vaccination intramuscularly on days 0,3,7 and 14
Biological: RABIPUR®
Biological rabies vaccine

Experimental: PIKA Rabies vaccine
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
Biological rabies vaccine
Other Name: PIKA rabies vaccine with PIKA adjuvant




Primary Outcome Measures :
  1. Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen [ Time Frame: 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.

  2. Identification of any adverse events for all the treatment groups [ Time Frame: 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.


Secondary Outcome Measures :
  1. Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course. [ Time Frame: Day 7 ]
    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



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02956421


Locations
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Singapore
SingHealth Investigational Medicine Unit
Singapore, Singapore, 169608
Clinical Trials & Research Unit
Singapore, Singapore, 529889
Sponsors and Collaborators
Yisheng Biopharma (Singapore) Pte. Ltd.
Investigators
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Principal Investigator: Limin Wijaya Singapore General Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Yisheng Biopharma (Singapore) Pte. Ltd.
ClinicalTrials.gov Identifier: NCT02956421     History of Changes
Other Study ID Numbers: RV001-II
First Posted: November 7, 2016    Key Record Dates
Last Update Posted: November 8, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs