Enrolling by invitation NCT07500207
A Phase III Clinical Trial on Immunogenicity and Safety of Lyophilized Rabies Vaccine for Human Use (Human Diploid Cell)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell), approved Rabies vaccine.
- Who it may be relevant to
- Registry conditions: Rabies Prevention. Basic parameters: 10 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of Lyophilized Human Rabies Vaccine (Human Diploid Cell) Administered Via Different Immunization Schedules Using a Randomized, Blinded, Positive-Controlled Design
Overview
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
Interventions
- Biological Experimental Lyophilized Human Rabies Vaccine (Human Diploid Cell)
Dosage schedule: Five-dose regimen: one dose on days 0, 3, 7, 14, and 28 respectively; 2-1-1 regimen: administration on days 0, 7, and 21, with 2 doses on day 0 and 1 dose on each of the other days; Simplified four-dose regimen: one dose on days 0, 3, 7, and 14, or one dose on days 0, 3, 7, and 28 respectively. - Biological approved Rabies vaccine
One dose shall be administered on days 0, 3, 7, 14, and 28 respectively.
Primary outcome measures
- neutralizing antibodies after the first dose [Time frame: 14 days and 42 day after the first dose]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
China · 1 center
- sichuan CDC — Neijiang
Identifiers
NCT: NCT07500207 · B1901-F20230313-2