Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant

NCT02657161 Phase 1 COMPLETED

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.

Details

Lead sponsor	Yisheng Biopharma (Singapore) Pte. Ltd.
Phase	Phase 1
Status	COMPLETED
Enrolment	37
Start date	2015-02
Completion	2015-07

Conditions

• Rabies

Interventions

• RABIPUR®
• PIKA rabies vaccine
• PIKA rabies vaccine with an accelerated regimen

Primary outcomes

• Identification of any adverse events for all the treatment groups — 42 days
  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.
• Titer level of Rabies Virus Neutralizing Antibody (RVNA) from serum at day 14 and 42 after the first injection — Day 14 and Day 42
  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

Countries

Singapore