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

YS-002

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.

2023-09-22

2024-03-22

2025-02-21

Active (not recruiting)

Early phase I

4500

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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2024-01-24