A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)

Changchun BCHT Biotechnology

Status and phase

Invitation-only

Phase 3

Conditions

Rabies Prevention

Treatments

Biological: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)

Biological: approved Rabies vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT07500207

B1901-F20230313-2

Details and patient eligibility

About

Neutralizing antibody seroconversion rate and geometric mean concentration in seronegative participants of each group at 14 days after the first dose of immunization.

The seroconversion rate of neutralizing antibodies 42 days after the first dose among seronegative participants before vaccination in each group

Enrollment

3,000 estimated patients

Sex

All

Ages

10 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants aged 10 to 60 years old;
Able to obtain informed consent from the participants themselves and/or their guardians;
The participants themselves and/or their guardians are able to comply with the requirements of the clinical trial protocol.

Exclusion criteria

Axillary temperature >37.0°C on the day of vaccination;
History of rabies vaccination or administration of rabies virus passive immunization preparations;
History of bites or scratches (with broken skin) by dogs or other mammals within 1 year before the first vaccination;
Suffering from an acute illness or acute exacerbation of a chronic disease within 3 days before the first vaccination;
Positive urine pregnancy test result or lactation in female participants of childbearing age, or pregnancy planning for female participants of childbearing age, male participants and their female sexual partners from the start of the trial until 6 months after the completion of the full vaccination course;
History of severe allergies requiring medical intervention or severe adverse reactions to vaccines (such as severe urticaria, anaphylactic shock, allergic laryngeal edema, allergic purpura, local allergic necrotizing reaction (Arthus reaction), angioedema, etc.), or allergy to any component of the investigational vaccine, such as human albumin, dextran 40, sucrose, glycine, disodium hydrogen phosphate, potassium dihydrogen phosphate;
Known or suspected malignant tumor, autoimmune disease, immunodeficiency or immunosuppression (e.g., human immunodeficiency virus (HIV) infection, organ transplantation, systemic lupus erythematosus (SLE), rheumatoid arthritis, etc.);
Use of immunosuppressive agents and/or immunomodulators (e.g., systemic glucocorticoids, targeted immunomodulators used continuously for more than 14 days), cytotoxic therapy, etc., within 6 months before the first vaccination or planned long-term use thereof;
Congenital malformations or developmental disorders affecting organ function, hypertension not effectively controlled by medication (only for those aged 18-60 years) [systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg despite maintenance medication], severe liver and kidney diseases (severe cases, e.g., complicated with diabetes), etc.;
Contraindications to intramuscular injection, such as local infection or skin lesions at the injection site, severe thrombocytopenia, abnormal coagulation function or history of coagulation disorders;
History or family history of mental and neurological diseases such as convulsions, epilepsy, encephalopathy and psychosis;
Received blood products or immunoglobulin products within the past 3 months or planned to use them during the trial;
Received other investigational medicinal products within 1 month before administration of the investigational vaccine or are currently participating in other clinical trials;
Received live attenuated vaccines within 14 days before enrollment, or subunit or inactivated vaccines within 7 days before enrollment;
Other conditions that the investigator considers may affect the trial.