Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-01-09 @ 11:32 AM
Study NCT ID:
NCT02657161
Status:
COMPLETED
Last Update Posted:
2016-01-15
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Sponsor:
Yisheng Biopharma (Singapore) Pte. Ltd.
Organization:
Study Overview
Official Title:
Phase I Study to Determine the Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
A single-center, open label, randomized phase I study in healthy naïve adult subjects. There were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12). Group A, as a control arm of the study, had received a commercially available rabies vaccine, RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14 was administered respectively. Group C 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 Group C 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.
Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and Group C 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: