A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried
- 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.
- Short title
- A Study to Evaluate a PIKA Rabies Vaccine（Vero Cell）for Human Use,Freeze-dried
- Official title
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2025-02-21
- First posted
- 2022-12-29
- Registry last updated
- 2024-07-23
- Primary completion date
- 2024-03-22
- Start date
- 2023-09-22
- Actual participants
- 4,500
- Participants
- 4,500
- Participant count basis
- Actual
- Protocol amendments
- Randomisation ratio
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Yisheng Biopharma (Singapore) Pte. Ltd.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05667974
- ClinicalTrials.gov ID
- NCT05667974
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Triple masking
- Masked roles
- Participants, Care providers, Investigators
Primary Immunogenicity
Timeframe: 14 days post-vaccination
GMTs of rabies virus neutralizing antibodies (RVNA) at Day 14 to demonstrate lot-to-lot consistency in all subjects enrolled in Group 1
Primary Immunogenicity
Timeframe: 14 days post-vaccination
RVNA seroconversion rate differences at Day 14 in all subjects enrolled in Group 1.
Co-primary Safety(solicited AEs)
Timeframe: 7 days after each vaccination.
Incidence of solicited local and systemic reactions on the day of each study vaccination
Co-primary Safety(unsolicited AEs)
Timeframe: From day of first vaccination through 14 days after the last vaccination
Incidence of unsolicited adverse events
Co-primary Safety(SAEs)
Timeframe: through study completion, an average of 1 year
Incidence of serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs), adverse events of special interest (AESIs) and AEs leading to withdrawal
Co-primary Safety
Timeframe: through study completion, an average of 1 year
Incidence of significant changes in the clinical laboratory test results, vital signs and physical examination by study visits.
Secondary Immunogenicity
Timeframe: Day 28 and Day 42
RVNA seroconversion rate differences at Day 28 and Day 42 in all subjects enrolled in Group 1
Secondary Immunogenicity
Timeframe: Day 7
RVNA seroconversion rate differences at Day 7 in all subjects (Group 1 and Group 2)
Secondary Immunogenicity
Timeframe: Day 14, 28 and 42
GMTs of rabies virus neutralizing antibodies (RVNA) on Day 14, 28 and 42(Group 1)
Secondary Immunogenicity
Timeframe: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2).
GMTs of rabies virus neutralizing antibodies (RVNA) on Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2) subjects (Group 1 and Group 2).
Secondary Immunogenicity
Timeframe: Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)
RVNA seroconversion rate differences on Day 90 and 180 for Group 1 only and Day 365 for all subjects (Group 1 and Group 2)
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- 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.
- 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.
- Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigator's judgment.
- Donation of blood within the last 2 months or who have donated plasma within the last 14 days before Study Day 0.
- Clinical signs of encephalitis.
- History or evidence on physical examination of any systemic disease or any acute or chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine.
- History of neurological disorder, either congenital or acquired (e.g. seizures, meningitis, encephalitis, Guillain-Barre syndrome, dementia, vasculitis, hereditary CNS disorders).
- History of cancer (malignancy) in the past 10 years (exception is non-melanomatous skin CA).
- A history of alcohol or drug addiction in the past 2 years.
- History of hypersensitivity or serious reactions (eg. anaphylaxis, urticarial, other significant reaction) to previous vaccinations.
- Plans to permanently move from the catchment area during trial conduct.
- Concerns of compliance with protocol or social condition that makes the subject a poor candidate for the trial as determined by the PI.
- Al-Shifa Trust Eye HospitalIslamabad, Pakistan
- Ziauddin UniversityKarachi, Pakistan
- Central Park Teaching HospitalLahore, Pakistan
- TDF-Lakeview，MuntinlupaCity of Muntinlupa, Philippines
- Las Pinas Doctor's HospitalLas Piñas, Philippines
- PGHManila, Philippines
- TDF - San Pablo, LagunaSan Pablo, Philippines
Related records
Drugs (2)
Lead sponsors (1)
Conditions (1)
- Rabies Primary condition