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

Официальное название

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

Обзор

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

Вмешательства

• Биопрепарат 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.
• Биопрепарат approved Rabies vaccine
  One dose shall be administered on days 0, 3, 7, 14, and 28 respectively.

Первичные конечные точки

• neutralizing antibodies after the first dose [Срок оценки: 14 days and 42 day after the first dose]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• sichuan CDC — Neijiang

Идентификаторы

NCT: NCT07500207 · B1901-F20230313-2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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