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 range
18 Years – 59 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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;
. 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);