Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell) (NCT07055880) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Immunogenicity and Safety of Different Dosages of Rabies Vaccine (Serum-free Vero Cell)
Pakistan120 participantsStarted 2025-07-28
Plain-language summary
To describe the immunogenicity and safety of two dosages of Sinovac rabies vaccine, as well as compared the differences with the marked WHO PQ rabies vaccine Verorab® in a post-exposure prophylaxis (PEP) schedule.
Who can participate
Age range18 Years – 59 Years
SexALL
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Inclusion criteria
✓. Populations aged 18\~59 years old;
✓. Participants are able to understand and sign the informed consent form (ICF) voluntarily;
✓. Participants are able to comply with the study procedures based on the investigator's assessment;
✓. 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);
✓. Participant was tested negative for HIV, Syphilis, Hepatitis B, Hepatitis C infection at the screening of this study (the test result should be provided);
✓. 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;
✓. 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;
✓. Participants should provide verifiable identifications, and contact or be contacted with the investigators during the study period.
Exclusion criteria
✕. Fever on vaccination day, with axillary temperature \>37.0°C pre-vaccination;
✕. Previous vaccination against rabies (in pre- or post-exposure regimen) with either trial vaccines or licensed vaccines;
What they're measuring
1
Proportion of participants achieving a RVNA titer ≥0.5 IU/mL
Timeframe: Day 14, Day 28 and Day 42 after the first dose vaccination
. Previous administration with rabies immunoglobulins or monoclonal antibodies;
✕. Bite by, or exposure to a potentially rabid animal in the previous 12 months with category Ⅱ or Ⅲ exposures;
✕. Female participants who are currently lactating or pregnant;
✕. 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;
✕. With severe congenital malformations or developmental disorders, genetic defects, severe malnutrition;
✕. With autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection);