Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)

Launched by SINOVAC BIOTECH CO., LTD · Jun 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the safety and immune response (how well the body fights the virus) of two different doses of a rabies vaccine made by Sinovac. It will also compare these doses to a well-known rabies vaccine called Verorab®, which is recommended by the World Health Organization. The goal is to see how effective and safe these vaccines are when given after someone has been exposed to rabies, as part of a treatment plan to prevent the disease.

Adults between 18 and 59 years old who are generally healthy and have not been vaccinated against rabies before may be eligible to join. Participants will need to understand the study and agree to take part voluntarily. Women who could become pregnant must have a negative pregnancy test and agree to use birth control during the study. People with serious health problems, allergies to vaccines, recent infections, or certain medications may not qualify. If accepted, participants will receive the vaccine and be closely monitored for side effects and how well their body responds to the vaccine. This trial is not yet recruiting, but it aims to help improve rabies prevention after exposure.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Populations aged 18\~59 years old;
• • 2. Participants are able to understand and sign the informed consent form (ICF) voluntarily;
• • 3. Participants are able to comply with the study procedures based on the investigator's assessment;
• • 4. In a stable health status (defined as a stable preexisting disease status during the past 3 months, i.e., no change in treatment or hospitalization due to exacerbation of preexisting diseases);
• • 5. Participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
• • 6. Female participants of childbearing potential were tested negative for urine pregnancy test pre-vaccination, and also need to have effective contraceptive measures in the previous 2 weeks pre-vaccination;
• • 7. Participants of childbearing potential and their partners are willing to take effective contraceptive measures and have no sperm or ovum donation plan from the time of signing ICF to 28 days after the last dose of vaccination;
• • 8. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period.
• Exclusion Criteria:
• • 1. Fever on vaccination day, with axillary temperature \>37.0°C pre-vaccination;
• • 2. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
• • 3. Previous administration with rabies immunoglobulins or monoclonal antibodies;
• • 4. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
• • 5. Female participants who are currently lactating or pregnant;
• • 6. Known serious allergy to vaccines or vaccine ingredients, such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, or known other serious adverse reactions to vaccine;
• • 7. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
• • 8. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);
• • 9. With poor controlled chronic illnesses or history of severe diseases, including but not limited to cardiovascular diseases, hematological disorders, liver and kidney diseases, digestive system disorders, respiratory diseases, malignancies, a history of major organ transplantation, drug-uncontrolled hypertension (with systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg), or any other disease or medical condition that the investigator believes could interfere with the trial results;
• • 10. With current or past history of severe neurological diseases (epilepsy, convulsions or seizures \[excluding history of febrile seizures\]) or psychiatric disorders, or presence of a family history of psychiatric disorders;
• • 11. With coagulation disorders (eg. factor deficiency, platelet disorders), or history of bleeding, hematoma, or bruising following intramuscular injections or venipuncture;
• • 12. Receipt of ≥14 days of immunosuppressive or other immunomodulatory therapy (prednisone ≥2mg/kg/day, or its equivalent), cytotoxic therapy within 180 days prior to screening, or plans for such treatment in this study;
• • 13. With long-term alcohol abuse \[\>14 drinks per week (1 drink =14 g 100% alcohol =360 mL beer, or 150 mL wine, or 45 mL distilled liquor/liquor)\] or substance abuse (repeated and heavy use of narcotic drugs, psychotropic drugs, volatile organic solvents, etc.)
• • 14. Receipt of blood products or immunoglobulins within 180 days prior to screening, or plans to receive these treatments in the study;
• • 15. Receipt of other investigational drugs/vaccines within 30 days prior to screening, or plans to receive such drugs or vaccines during the study period;
• • 16. Currently participating in other vaccine or drug clinical trials, or plan to participate in other clinical trials during the study;
• • 17. Receipt of live-attenuated vaccines within 14 days prior to screening, or subunit or inactivated vaccines within 7 days prior to screening;
• • 18. Presence of skin injuries, inflammation, ulcers, rashes, scars, or other conditions at the intended vaccination site that may interfere with drug administration or observation of local reactions;
• • 19. Acute onset of various acute diseases or chronic diseases within the past 7 days, or known or suspected active infections;
• • 20. Any other factors considered by the investigator to make the participant unsuitable for participation in the study