Rabies
Conditions
Interventions
Control group:Essen regimen "D0,3,7,14,28 (1-1-1-1-1)", will be administered 1 dose on D0, D3, D7, D14, and D28
Trial group 1:Zagreb regimen "D0,7,21 (2-1-1)", will be administered 2 doses on D0 1 dose each on D7 and D21
Trial group 2 (Trial group 2.1): "D0,3,7,14 (1-1-1-1)", will be administered 1 dose on D0, D3, D7, D14
Trial group 2 (Trial group 2.2):"D0,3,7,28 (1-1-1-1)", will be administered 1 dose on D0, D3, D7, D28
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Academy of Preventive Medicine)
Eligibility
Sex/Gender
All
Age
No minimum to 60 Years
Inclusion criteria
Inclusion criteria: (1) Healthy males or females; (2) Obtain informed consent from the subject or guardian and have the subject sign the informed consent form; (3)No history of rabies exposure, never received rabies vaccine or rabies immunoglobulin; (4) Agree to refrain from blood donation and avoid elective surgery during the study; (5) Be able to commit to the vaccination schedule in the study; (6)Axillary temperature<=37?; (7) The ability and commitment to comply with the requirements of the study, such as completion of diary cards, return for follow-up visits, accessibility by phone and residence within the study area for the duration of the study; (8) Pregnancy test is negative (Pregnancy testing may not be performed for female subjects who have evidence that they do not have the possibility of pregnancy [such as surgical sterilization]); (9) Agree to avoid pregnancy with acceptable methods of contraception 6 months after full course of vaccination (apply to female subjects who are capable of pregnancy and male subjects who are sexually active with a woman)
Exclusion criteria
Exclusion criteria: 1) History of rabies infection or treatment (immunization with rabies vaccine, or rabies immunoglobulin), or have had contact with suspected rabid animals within 12 months. 2) At high risk of rabies infection during the trial: (e. g., veterinarians and their staff, animal keepers, rabies researchers and certain laboratory workers with frequent exposure to rabies virus, or bats, raccoons, skunk, cats, dogs, or other species that have the possibility of rabies, people traveling to places where rabies is endemic, and previously bitten by rabid animals without post-exposure treatment). Those who have cats or dogs at home may be included in the group, except in cases with the high-risk conditions mentioned above. 3) History of allergic diseases or allergy to any component of the study vaccine (inactivated rabies virus, human serum albumin, maltose, gelatin, sodium chloride, sodium dihydrogen phosphate, sodium dihydrogen phosphate). 4) Upon reviewing the medical history, there are cases of neurological disorders such as convulsions, epilepsy, and brain diseases, as well as severe depression or anxiety, autism, and other psychiatric conditions, along with other serious systemic diseases that may affect the study process.. 5) Any systemic disease or any acute or uncontrollable chronic disease that the researchers believe may interfere with the safety or immunogenicity assessment of the vaccine, such as severe cardiovascular disease, previously diagnosed diabetes with poor blood sugar control or severe diabetes (with complications), severe liver and kidney disease, malignant tumors, and drug-uncontrollable hypertension (>=18 years old, systolic blood pressure >=160mmHg and/or diastolic blood pressure >=100mmHg; =152mmHg and/or diastolic blood pressure >=95mmHg). 6) Confirmed or suspected immunosuppressive or immunodeficient diseases, including human immunodeficiency virus (HIV) infection. 7) History of Hepatitis B or C (HBV or HCV) infection. 8) Donation of blood within the last 2 months or have donated plasma protein within the last 14 days 9) Planned or expected use of substances such as immunosuppressants, steroids and non-test vaccines during the clinical study which may affect the response of the subjects to the Investigation product, including those planning to receive vaccines under the immunization schedule. 10) Plan to use immunoglobulin or any blood products during the study period or within 3 months before the first vaccination. 11) Within 3 months before the first injection, systemic use of corticosteroid medications for a long time (more than 14 days), except for topical use (such as ointment, eye drops, inhalants or nasal sprays) that do not exceed the recommended dose in the drug instructions. 12) Received any other attenuated vaccine within 30 days before the first vaccination, or received other subunit or inactived vaccine within 2 weeks before the first vaccination. 13) A history of alcohol or drug addiction in the past 2 years 14) History of cancer (malignancy) (exception is non-melanomatous skin CA). 15) Received any investigational therapy (including vaccine) within 90 days before randomization, or planned participation in any other investigational study during the study period. 16) Breastfeeding women. 17) Any condition/s that may affect the study evaluation based on the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum RVNA positive conversion rate;GMC;Serum RVNA positive conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum RVNA positive conversion rate;GMC;GMC of serum RVNA;Serum RVNA positive conversion rate;GMC;Any local and systemic AE;Solicited AE;Unsolicited AE;SAE, SUSAR and AE leading to withdrawal ; | — |
Countries
China
Contacts
Public ContactQi Liang
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Academy of Preventive Medicine)
Outcome results
None listed