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

NCT02956421 | Completed Phase 2 DMC

• 1 other identifier: RV001-II
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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.

Conditions

Rabies

Outcome Measures

Primary Outcomes (2)

• Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at accelerated regimen

  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.

  42 days

• 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.

  42 days

Secondary Outcomes (1)

• Number of subjects in Group B who has higher RVNA titre level on Day 7 when compared to classic course.

  Day 7

Study Arms (2)

RABIPUR®

ACTIVE COMPARATOR

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

Biological: RABIPUR®

PIKA Rabies vaccine

EXPERIMENTAL

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

Interventions

RABIPUR® BIOLOGICAL

Biological rabies vaccine

RABIPUR®

PIKA rabies vaccine BIOLOGICAL

Biological rabies vaccine

Also known as: PIKA rabies vaccine with PIKA adjuvant

PIKA Rabies vaccine

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yisheng Biopharma (Singapore) Pte. Ltd.: lead

Study Sites (2)

SingHealth Investigational Medicine Unit

Singapore, Singapore, 169608, Singapore

Location

Clinical Trials & Research Unit

Singapore, Singapore, 529889, Singapore

Location

Related Publications (2)

• 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.

  PMID: 37821317 DERIVED

• 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.

  PMID: 29174316 DERIVED

MeSH Terms

Conditions

Rabies

Interventions

PIKA adjuvant

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Limin Wijaya

  Singapore General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 7, 2016
• Study Start: February 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: November 8, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)