NCT02657161

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 15, 2016

Completed
Last Updated

January 15, 2016

Status Verified

January 1, 2016

Enrollment Period

5 months

First QC Date

January 11, 2016

Last Update Submit

January 13, 2016

Conditions

Rabies

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

    Day 14 and Day 42

Secondary Outcomes (2)

  • Detectable specific T cell mediated immune response on day 7 or day 14 and 42

    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.

    Day 7 and Day 14

Study Arms (3)

Group A

ACTIVE COMPARATOR

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

Biological: RABIPUR®

Group B

EXPERIMENTAL

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

Biological: PIKA rabies vaccine

Group C

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 with an accelerated regimen

Interventions

RABIPUR®BIOLOGICAL

Biological rabies vaccine

Group A
PIKA rabies vaccineBIOLOGICAL

Biological rabies vaccine

Also known as: 'PIKA rabies vaccine with PIKA adjuvant
Group B
PIKA rabies vaccine with an accelerated regimenBIOLOGICAL

Biological rabies vaccine

Also known as: 'PIKA rabies vaccine with PIKA adjuvant
Group C

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SingHealth Investigational Medicine Unit

Singapore, Singapore, 169608, 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: 37821317DERIVED

  • 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.

    PMID: 28118938DERIVED

MeSH Terms

Conditions

Rabies

Interventions

PIKA adjuvant

Condition Hierarchy (Ancestors)

Rhabdoviridae InfectionsMononegavirales InfectionsRNA Virus InfectionsVirus DiseasesInfections

Study Officials

  • Limin Wijaya

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2016

First Posted

January 15, 2016

Study Start

February 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 15, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)