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

• Register: ClinicalTrials.gov
• Last refreshed on: 25 January 2016
• Main ID: NCT02657161
• Date of registration: 11/01/2016
• Prospective Registration: No
• Primary sponsor: Yisheng Biopharma (Singapore) Pte. Ltd.
• Public title: Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
• Scientific title: Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
• Date of first enrolment: February 2015
• Target sample size: 37
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02657161
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: Limin Wijaya
• Affiliation: Singapore General Hospital

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Rabies

Intervention(s)

Biological: RABIPUR®

Biological: PIKA rabies vaccine with an accelerated regimen

Biological: PIKA rabies vaccine

Primary Outcome(s)

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

Identification of any adverse events for all the treatment groups [Time Frame: 42 days]

Secondary Outcome(s)

Detectable specific T cell mediated immune response on day 7 or day 14 and 42 [Time Frame: 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. [Time Frame: Day 7 and Day 14]

Secondary ID(s)

RV001-I

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Duke-NUS Graduate Medical School