Virus Diseases Clinical Trial
Official title:
A Phase III Randomized Blinded Study to Evaluate SYN023 Compared to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies in Adults With Category III Rabies Exposure Risks
Verified date | March 2023 |
Source | Synermore Biologics (Suzhou) Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP). The trial will enroll the World Health Organization (WHO) Category III rabies exposure subjects. The subject's death and rabies data will be reviewed by Data and safety monitoring board (DSMB) to confirm the safety. Besides, rabies vaccine would be administered after Study Drug in each group. This trial is proposed to further the licensure of SYN023 to provide an effective PEP alternative available to those exposed persons who need such a product. A placebo-controlled rabies trial is unethical thus HRIG is selected as the control group. Rabies immune globulin from equine and human sources (HRIG) have been evaluated in many trials and HRIG is the standard of care in China.
Status | Completed |
Enrollment | 1000 |
Est. completion date | December 16, 2022 |
Est. primary completion date | June 24, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Is age =18 years, on Study Day 1 with legal identification documents, and plan to live in the local administration area during the study; 2. Category III rabies exposure within 24 hours before Study Drug receipt ; 3. Completed written informed consent process, and signed the informed consent forms; 4. Subjects with the ability to understand the study procedure. And agreed to complete all follow-ups; 5. Female subjects are not in pregnancy (with negative results of urine pregnancy tests before vaccination) and are not in the period of breast feeding, and agree to avoid pregnancy within 121 days after administration; 6. Those who have an armpit temperature = 37.0 °C. Exclusion Criteria: 1. Previous receipt of equine or human (rabies) globulin or rabies vaccination prior to randomization; 2. Clinical evidence of rabies infection; 3. Category I and Category II rabies exposure; 4. Had fever (armpit temperature = 38.5 °C) within 3 days before Study Day 1, or in the acute episode of any chronic diseases; 5. Received immunoglobulin or blood products (except for the anti-tetanus immunoglobulin) within 43 days before Study Day 1, or plan to use any such product (except for the anti-tetanus immunoglobulin) during the study; 6. Received systemic immunosuppressant medication such as systemic corticosteroids but not limited to systemic corticosteroids within 43 days before Study Day 1; 7. History of any immunodeficiency disease (for example: AIDS, systemic lupus erythematosus, etc.); or Laboratory evidence of previous or current immunodeficiency disease, including, but not limited to, any laboratory evidence of HIV infection; 8. History of spleen function deficiency or function injury, such as no spleen caused by any cause (such as splenectomy); 9. History of any severe allergy for vaccination, such as systemic urticaria, allergic laryngeal edema, anaphylactoid purpura, local allergic necrosis (Arthus reaction), angioedema, anaphylactic shock, etc., or allergic to any ingredient of the study drug/vaccine; 10. Previous receipt of any study product (drug, vaccine, biological product or medical device) within 6 months before Study Day 1, or plan to participate in any other clinical study during this study period; 11. History of or clinical evidence of any systemic disease, acute disease or chronic disease (such as convulsions, epilepsy, encephalopathy, nephrotic syndrome, etc.) that the investigator considers to be likely to interfere with safety or efficacy assessment of the study; 12. Previous medical history that may compromise the safety of the subject in the study according to the opinion of the principal investigator. |
Country | Name | City | State |
---|---|---|---|
China | Yunnan Province Center for Disease Control and Prevention (CDC) | Kunming |
Lead Sponsor | Collaborator |
---|---|
Synermore Biologics (Suzhou) Co., Ltd. | Simoon Record Pharma Information Consulting Co., Ltd. |
China,
Ding Y, Wu M, Zhang H, Zhu X, Hu Y, Li X, Liu J, Tsao E, Liu M, Li C. Safety, pharmacokinetics and pharmacodynamics of SYN023 alone or in combination with a rabies vaccine: An open, parallel, single dose, phase 1 bridging study in healthy Chinese subjects — View Citation
McClain JB, Chuang A, Reid C, Moore SM, Tsao E. Rabies virus neutralizing activity, pharmacokinetics, and safety of the monoclonal antibody mixture SYN023 in combination with rabies vaccination: Results of a phase 2, randomized, blinded, controlled trial. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) at Study Day 8 | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). | Day 8 | |
Primary | Number of Probable or Confirmed Rabies Cases | WHO's Classification of Rabies Cases:
Suspected case: refers to a case that satisfies the definition of clinical case; Probable case: refers to a suspected case with a reliable medical history of contact with any suspected animal infected with the rabies virus; Confirmed case: refers to a suspected or probable case that is proved to be infected based on the lab test result. |
Day 1 to Day 365 | |
Secondary | Rabies Virus Neutralizing Activity (RVNA) of Geometric Mean Concentration (GMC) | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). | Days 4, 15, 43, 99, 183 and 365 | |
Secondary | Percentage of Participants With Rabies Virus Neutralizing Activity (RVNA) =0.5 IU/mL | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). | Days 4, 8, 15, 43, 99, 183 and 365 | |
Secondary | Area Under the Efficacy Curve for the Geometric Mean Concentration (GMC) of Rabies Virus Neutralizing Activity (RVNA) | Rabies Virus Neutralizing Activity (RVNA) was assessed using Rapid Fluorescent Focus Inhibition Test (RFFIT). Area Under the Efficacy Curve for the GMC of RVNA from Study Day 1 to Day 15 after administration (AUEC1-15) | Day 1 to Day 15 |
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