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

NCT05667974 | Unknown Phase 3

• 1 other identifier: YS-002
• Study Type: interventional
• Target: 4,500
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Rabies; Prevention

Keywords

Rabies; vaccine; prophylactic

Outcome Measures

Primary Outcomes (6)

• Primary Immunogenicity

  GMTs of rabies virus neutralizing antibodies (RVNA) at Day 14 to demonstrate lot-to-lot consistency in all subjects enrolled in Group 1

  14 days post-vaccination

• Primary Immunogenicity

  RVNA seroconversion rate differences at Day 14 in all subjects enrolled in Group 1.

  14 days post-vaccination

• Co-primary Safety(solicited AEs)

  Incidence of solicited local and systemic reactions on the day of each study vaccination

  7 days after each vaccination.

• Co-primary Safety(unsolicited AEs)

  Incidence of unsolicited adverse events

  From day of first vaccination through 14 days after the last vaccination

• Co-primary Safety(SAEs)

  Incidence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs) and AEs leading to withdrawal

  through study completion, an average of 1 year

• Co-primary Safety

  Incidence of significant changes in the clinical laboratory test results, vital signs and physical examination by study visits.

  through study completion, an average of 1 year

Secondary Outcomes (5)

• Secondary Immunogenicity

  Day 28 and Day 42

• Secondary Immunogenicity

  Day 7

• Secondary Immunogenicity

  Day 14, 28 and 42

• Secondary Immunogenicity

  Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2).

• Secondary Immunogenicity

  Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)

Study Arms (2)

PIKA Rabies

EXPERIMENTAL

Receive 1 of the 3 lots of PIKA rabies vaccine via IM administration that 2-2-1 schedule with a double-dose injection on Day 0 and 3 and a single-dose injection on Day 7

Biological: PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried

Control

ACTIVE COMPARATOR

Receive ChiroRab via IM administration that the classic Essen 5-dose regimen 1-1-1-1-1 schedule on Days 0, 3, 7, 14 and 28

Biological: Chirorab

Interventions

PIKA Rabies Vaccine (Vero Cell) for Human use, Freeze-dried BIOLOGICAL

PIKA rabies vaccine

PIKA Rabies

Chirorab BIOLOGICAL

Active Comparator

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has completed the written informed consent process.
• For Singapore sites: age ≥21 and ≤ 65 years on Study Day 0; for other country sites: age ≥18 and ≤ 65 years on Screening.
• Healthy males and females.
• No history of rabies exposure, administration of rabies vaccination or rabies immunoglobulin.
• Agree to refrain from blood donation during the course of the study.
• Be able to commit to the vaccine schedule strictly.
• Has the ability and commitment to comply with requirements of the study, such as completion of diary cards, return for follow-up visits, accessible by phone and reside within the study area for the duration of study.
• For female subjects: agree to avoid pregnancy from Study Day 0 to Study Day 90 during the course of the study. Women physically capable of pregnancy (not sterilized and still menstruating or within 1 year of the last menses if menopausal) in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence (not engaging in sexual intercourse), hormonal contraceptives (oral, injection, transdermal patch, or implant), vaginal ring, intrauterine device (IUD), or the combination of a condom or diaphragm with spermicide.

You may not qualify if:

• Pregnant and nursing female volunteers will be excluded from the study.
• Previous exposure to a suspect rabid animal within the last 12 months.
• Any subject who needs post-exposure prophylaxis against rabies.
• History of rabies infection or treatment (immunoglobulin or vaccine).
• History of previous rabies vaccination.
• History of hypersensitivity reaction to human immunoglobulin.
• Received any vaccine in the past 30 days before randomization except for COVID 19 and flu vaccination.
• Received immunoglobulin or blood products within 90 days before randomization or plans to receive such products at any time during active period of the study (through Day 90).
• Received any investigational therapy (including vaccine) within 90 days before randomization, or planned participation in any other investigational study during the active study period (through Day 90).
• Used immunosuppressant medications in the past 180 days (defined as more than 14 continuous days before randomization or plans to receive any products during the active vaccination period (through Day 28). An immunosuppressant dose of a glucocorticoid will be defined as a systemic dose of ≥10mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted).
• At high risk for rabies infection during the trial: (such as veterinarians and their staff, animal handlers, rabies researchers, and certain laboratory workers, persons whose activities bring them into frequent contact with rabies virus or potentially rabid bats, raccoons, skunks, cats, dogs, or other species at risk for having rabies, people travelling where rabies is enzootic, previous bite by a rabid animal with no post-exposure treatment administered).
• History of HBV or HCV infection.
• History of any past, present, or future possible immunodeficiency state including but not limited to any laboratory indication of HIV-1 infection.
• History of treatment for depression or mental illness in the past 5 years; history of any attempt of suicide.
• Donation of blood within the last 2 months or who have donated plasma within the last 14 days before Study Day 0.

Sponsors & Collaborators

• Yisheng Biopharma (Singapore) Pte. Ltd.: lead

Study Sites (7)

Al-Shifa Trust Eye Hospital

Islamabad, Pakistan

Location

Ziauddin University

Karachi, Pakistan

Location

Central Park Teaching Hospital

Lahore, Pakistan

Location

TDF-Lakeview，Muntinlupa

City of Muntinlupa, Philippines

Location

Las Pinas Doctor's Hospital

Las Piñas, Philippines

Location

PGH

Manila, Philippines

Location

TDF - San Pablo, Laguna

San Pablo, Philippines

Location

MeSH Terms

Conditions

Rabies

Interventions

Freeze Drying

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Cryopreservation; Tissue Preservation; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Preservation, Biological; Therapeutics; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2022
• First Posted: December 29, 2022
• Study Start: September 22, 2023
• Primary Completion: March 22, 2024
• Study Completion: February 21, 2025
• Last Updated: July 23, 2024

Record last verified: 2023-11

Locations

PA (3); PH (4)