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

NCT02657161 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2016-01-15

No results posted yet for this study

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.

Conditions

  • Rabies

Interventions

BIOLOGICAL

RABIPUR®

Biological rabies vaccine

BIOLOGICAL

PIKA rabies vaccine

Biological rabies vaccine

BIOLOGICAL

PIKA rabies vaccine with an accelerated regimen

Biological rabies vaccine

Sponsors & Collaborators

  • Duke-NUS Graduate Medical School

    collaborator OTHER

  • Yisheng Biopharma (Singapore) Pte. Ltd.

    lead INDUSTRY

Principal Investigators

  • Limin Wijaya · Singapore General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02657161 on ClinicalTrials.gov