NCT05667974

A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried

A Phase III, Randomized, Comparator-Controlled, Double-Blind, Multicenter Study to Evaluate the Immunogenicity, Safety and Lot to Lot Consistency of Three Lots of a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried in Healthy Adults Using a Post-Exposure Prophylaxis Schedule

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,500 (actual)
• Sponsor: Yisheng Biopharma (Singapore) Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab.

Detailed description

This is a phase III, randomized, comparator-controlled, double-blind, multicenter study to evaluate lot-to-lot consistency of three lots of a PIKA Rabies Vaccine, immunogenicity and safety in healthy adults using a post-exposure prophylaxis schedule. It is also the aim of this study to evaluate non-inferiority and superiority of the PIKA Rabies Vaccine compared to the rabies vaccine comparator ChiroRab. A total of 4,500 subjects will be enrolled in the study randomized into 2:1 with 3000 subjects allocated to PIKA rabies vaccine and 1,500 allocated to receive the comparator rabies vaccine ChiroRab . There will be two study Groups: Group 1 (20%) and Group 2 (80%). Within each study group, subjects will be randomly allocated in a 2:2:2:3 ratios to receive 1 of the 3 lots of PIKA rabies vaccine or ChiroRab. The ChiroRab group will receive the classic Essen 5 dose regimen (1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28), whilst the PIKA rabies vaccine group will receive an accelerated regimen (2-2-1 schedule with a double-dose injection on Days 0 and 3 and a single-dose injection on Day 7). For blinding purposes, normal saline will be injected on Days 14 and 28 for PIKA rabies group and Days 0 and 3 for ChiroRab group. Group 1 will enrol a total of 900 subjects, approximately 20% of the total sample population. Subjects will be randomized at 2:2:2:3 ratio (PIKA lot #1: 200 subjects, PIKA lot #2: 200 subjects, PIKA lot #3: 200 and 300 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination (Day 0) and post-vaccination on Days 7, 14, 28, 90, 180 and 365 to evaluate the primary immunogenicity, safety and secondary immunogenicity endpoints. Subjects will be followed up for the whole study period through clinic visits or phone calls. The first 50 participants randomized in each of the 3 PIKA lots and that for the ChiroRab in Goup 1 (200 in total) will form the safety subset and will have additional blood draw for safety laboratory parameters for CBC platelet, urinalysis, serum chemistry and coagulation on Day 0 (prior to vaccination), Day 7 and Day 28. After completion of enrolment in Group 1, Group 2 will enrol the remaining 3,600 subjects at 2:2:2:3 randomization ratio (PIKA lot #1: 800 subjects, PIKA lot #2: 800 subjects, PIKA lot #3: 800 and 1,200 will be randomized to receive ChiroRab). Blood will be collected pre-vaccination on Day 0, 7 and 365 to evaluate key secondary immunogenicity endpoints of superiority, persistence and durability of immune response as well as co-primary safety objective. Subjects will be followed up for the whole study period through clinic visits or phone calls. After each vaccination, all subjects will be observed in the clinical site for at least 30 minutes for immediate reactions and will be followed up for solicited AEs by diary cards 7 days post each vaccination and unsolicited AEs will be collected through Day 41 post first vaccination. All subjects will be monitored for SAEs, SUSARs, AESIs, and AEs leading to study withdrawal for the whole study period.

Conditions

• Rabies
• Prevention

Interventions

Type	Name	Description
BIOLOGICAL	PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried	PIKA rabies vaccine
BIOLOGICAL	Chirorab	Active Comparator

Timeline

• Start date: 2023-09-22
• Primary completion: 2024-03-22
• Completion: 2025-02-21
• First posted: 2022-12-29
• Last updated: 2024-07-23

Locations

7 sites across 2 countries: Pakistan, Philippines