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

NCT ID: NCT02956421

Last Updated: 2016-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-10-31

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.

Conditions

Rabies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

RABIPUR®

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

Group Type: ACTIVE_COMPARATOR

RABIPUR®

Intervention Type: BIOLOGICAL

Biological rabies vaccine

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)

Group Type: EXPERIMENTAL

PIKA rabies vaccine

Intervention Type: BIOLOGICAL

Biological rabies vaccine

Interventions

RABIPUR®

Biological rabies vaccine

Intervention Type: BIOLOGICAL

PIKA rabies vaccine

Biological rabies vaccine

Intervention Type: BIOLOGICAL

Other Intervention Names

PIKA rabies vaccine with PIKA adjuvant

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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yisheng Biopharma (Singapore) Pte. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Limin Wijaya

Role: PRINCIPAL_INVESTIGATOR

Singapore General Hospital

Locations

SingHealth Investigational Medicine Unit

Singapore, Singapore, Singapore

Clinical Trials & Research Unit

Singapore, Singapore, Singapore

Countries

Singapore

References

Yu P, Liu Y, Tao X, He Y, Liu Q, Wang B, Zheng H, Zhang N, Bi S, Zhu W, Zhang Y. Potential option for rabies post-exposure prophylaxis: New vaccine with PIKA adjuvant against diverse Chinese rabies strains. Vaccine. 2023 Nov 2;41(46):6852-6862. doi: 10.1016/j.vaccine.2023.10.001. Epub 2023 Oct 9.

Reference Type: DERIVED

PMID: 37821317 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29174316 (View on PubMed)

Other Identifiers

RV001-II

Identifier Type: -

Identifier Source: org_study_id