Clinical trial NCT06548139: Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials
Official title: Multicenter, Randomized, Double-blind, Positive Control Evaluation of Rabies Monomab CBB 1 Combination Vaccine for Antibody Neutralization Activity and Safety Phase Clinical Trials in Healthy People
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Rabies Virus Infection
Keywords: Rabies Virus Neutralizing Antibodies
Safety
Immunogenicity
Lead sponsor: Changchun BCHT Biotechnology Co.
Sponsor class: INDUSTRY
Collaborators: name: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
name: Anning City First People's Hospital
name: Yunnan Central Hospital
name: Beijing Contreke Statistical Technology Co., LTD
name: Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD
First posted: 2024-08-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There were 120 healthy people aged 10-50 years, divided into 3 groups: test group 1 rabies mAb CBB1 50.0 µ g / kg + vaccine; test group 2 rabies mAb CBB1 100.0 µ g / kg + vaccine; and control group HRIG 20IU / kg + vaccine
Primary purpose: PREVENTION

Brief summary: To evaluate the antibody neutralization activity and safety of rabies mAb CBB 1 combination vaccine used in healthy people

Detailed description: To evaluate the rabies virus neutralizing antibody (RVNA) activity of rabies mAb CBB 1 in combination with human rabies vaccine (Vero cells) in healthy volunteers.

To evaluate the safety and tolerability of rabies mAb CBB 1 compared to HRIG in combination with human rabies vaccine (Vero cells) in healthy volunteers.

To evaluate the immunogenicity of rabies mAb CBB 1.

Eligibility criteria: Inclusion Criteria:

1. Before the trial, I have had a detailed understanding of the nature, significance and possible benefits of the trial, the possible inconvenience and potential risks and discomfort, and volunteered to participate in this clinical trial, was able to communicate well with researchers, comply with the requirements of the whole study, and signed a written informed consent;
2. Men or women aged 18\~50 (including boundary values) at the time of screening;
3. The weight of female volunteers was 45.0 kg and 80.0 kg, that of male volunteers was 50.0 kg and 80.0 kg, and the body mass index (BMI) was between 18.0 and 27.0 kg/m2 (including boundary value) (BMI= weight kg / height m2);
4. Female volunteers have no fertility or egg donation plan within 14 days before the first dose to 3 months after the end of the trial and voluntarily take effective physical contraception, while male volunteers have no fertility or sperm donation plan within 3 months after the first dose to the trial and voluntarily take effective physical contraception.

Exclusion Criteria:

1. Those who are known to be allergic to the study drug (including excipients, similar drugs), or suffer from severe allergic diseases or allergic constitution (such as allergic to two or more drugs, food or pollen), may damage the safety of the volunteers in the judgment of the investigator (inquiry);
2. Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
3. Patients with a history of clinically serious disease within 6 months (180 days) before the first dose and not cured, or patients with acute or chronic diseases that may significantly affect the in vivo process or safety evaluation of the study drug (inquiry);
4. Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
5. Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
6. Those who have received major surgery within 3 months (90 days) prior to the first dose, or those who may significantly affect the internal process or safety evaluation of the study drug (inquiry, inquiry);
7. Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);
8. Suspected or clear identification of a history of injuries to warm-blooded mammals in the last 12 months (360 days) (warm-blooded animals refer to animals that can regulate their body temperature, also known as endotherms. Birds and the vast majority of mammals, including the cats and dogs around them, are warm-blooded animals) (inquiry);
9. Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);
10. Those who have used a rabies passive immunization preparation or used systemic immunosuppressive agents such as glucocorticoids within 3 months (90 days) prior to the first dose (inquiry, inquiry)；
11. Those who have been used or are in the current period) or who may have a significant impact on the in vivo process or safety evaluation of the study drug (inquiry, inquiry);
12. Any clinical trial drug or device used within 3 months (90 days) prior to the first dose, or \<5 half-lives of the last previous trial drug dose (whichever is older), or planned to participate in other clinical trials during the study (inquiry, inquiry);
13. Regular alcohol for 3 months (90 days) before the first dose (3 times a week, and an average of 50° of liquor 200 ml) (inquiry);
14. Those with positive alcohol breath test or test value\> 0 mg / 100 ml (examination);
15. Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);
16. Those who lost blood / donated more than 400 ml (other than female physiological blood loss) within 3 months (90 days) before the first dose, or who received blood transfusion or used blood products, or planned to donate blood during the trial or within 1 month (30 days) after the end of the trial (inquiry);
17. Those who ingested alcohol-containing products within 24 hours before the first dose (inquiry);
18. Abnormalities at the administration site (such as inflammation, induration, redness, large area scar or tattoo, etc.) shall affect the administration or the clinical observer (examination);
19. Those with a history of substance abuse (inquiry);
20. Those who are screened positive for substance abuse during the screening period (examination);
21. Those who are positive for the initial HIV screening during the screening period (screening);
22. two half and half qualitative tests of hepatitis B during the screening period (examination);
23. Patients with positive results for hepatitis C virus antibody or treponema pallidum antibody during the screening period (examination);
24. Physical examination, vital signs (respiration, blood pressure, pulse rate), electrocardiogram, other laboratory tests (laboratory tests not listed separately) or other auxiliary examination results are judged as abnormal and clinically significant by the study doctor (examination);
25. Ear temperature during the screening period is\> 37.5℃ (examination);
26. Women who are positive in pregnancy or lactation or screening pregnancy test (inquiry, examination);
27. Patients with a history of needle acupuncture, blood sickness, or unable to tolerate venipuncture (inquiry);
28. The volunteers may be unable to cooperate with the study for other reasons or the investigators is not unsuitable for inclusion.

Primary outcomes:
measure: Rabia for neutralizing antibody activity
timeFrame: 7 Days
Secondary outcomes:
measure: Rabia for neutralizing antibody activity
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Safety evaluation index
timeFrame: 105 Days
measure: Immunogenicity evaluation index
timeFrame: 105 Days
Other outcomes:
Locations:
city: Kunming
country: China
facility: The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine
state: Yunnan
Study officials:
References: