Rabies mAb CBB 1 Combination Vaccine in Healthy People With Antibody Neutralization Activity and Safety Phase Clinical Trials

NCT06548139 | Not Yet Recruiting Phase 2

• 1 other identifier: B1801-F20220212
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rabies Virus Infection

Keywords

Rabies Virus Neutralizing Antibodies; Safety; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• Rabia for neutralizing antibody activity

  Geometric mean RVNA concentration on day 7 after medication; Proportion of volunteers with 0.5 IU / ml of RVNA on day 7 after medication.

  7 Days

Secondary Outcomes (9)

• Rabia for neutralizing antibody activity

  105 Days

• Safety evaluation index

  105 Days

• Safety evaluation index

  105 Days

• Safety evaluation index

  105 Days

• Safety evaluation index

  105 Days

Study Arms (3)

Experimental group 1

EXPERIMENTAL

Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart.

Drug: Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg; Biological: Lyophilized rabies vaccine for human use (Vero cells)

Experimental group 2

EXPERIMENTAL

Natural full human monoclonal antibody CBB 1 injection：Each dose (2.5ml) contained 0.5 mg / natural monoclonal antibody ml CBB 1 Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection Character: colorless to pale green and yellow liquid Specification: 1.25 mg (2.5 ml) / bottle Mode of administration: intramuscular injection of the vastus lateralis muscle. Usage and dosage: The injection dose was calculated according to the group and body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site, and at least 2.5 cm apart.

Drug: Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg; Biological: Lyophilized rabies vaccine for human use (Vero cells)

Positive control group

ACTIVE COMPARATOR

Rabies Human Immunoglobulin (HRIG) Active ingredient: Rabid human immunoglobulin Specification: 200 IU / 2 ml / bottle Administration mode: intramuscular injection of the vastus lateral muscle group. Usage and dosage: the injection dose was calculated according to the body weight of the volunteer. On day 0, unilateral or bilateral extrafemoral muscle group injections were selected by dose, with no more than 5 mL at each site and at least 2.5 cm apart

Drug: Rabies Human Immunoglobulin (HRIG); Biological: Lyophilized rabies vaccine for human use (Vero cells)

Interventions

Natural full human monoclonal antibody CBB 1 injection 50.0µg/kg DRUG

Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

Experimental group 1

Natural full human monoclonal antibody CBB 1 injection 100.0µg/kg DRUG

Active ingredient: natural full human monoclonal antibody CBB 1 containing 0.5 mg / ml per dose (2.5ml) Ingredients: 25 mM citrate buffer, 125 mM sodium chloride, 0.02% (w / v) polysorbate 20 and water for injection

Experimental group 2

Rabies Human Immunoglobulin (HRIG) DRUG

Active ingredient: Rabid human immunoglobulin

Positive control group

Lyophilized rabies vaccine for human use (Vero cells) BIOLOGICAL

Active ingredient: inactivated rabies virus fixed poison

Experimental group 1; Experimental group 2; Positive control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Men or women aged 18\~50 (including boundary values) at the time of screening;
• 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);
• 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.

You may not qualify if:

• 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);
• Those with a clear history of allergy to the essential substances (such as skin disinfectants) that may be exposed to during the test (inquiry);
• 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);
• Patients with a previous history of autoimmune diseases or chronic hepatitis (inquiry);
• Patients with a previous history of convulsions, epilepsy, mental or nervous system, or a family history of convulsions or epilepsy (inquiry);
• 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);
• Patients with a history of rabies virus infection or have received rabies vaccination (inquiry);
• 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);
• Having received a vaccine other than the rabies vaccine within 1 month (30 days) prior to the first dose (inquiry);
• 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)；
• 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);
• 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);
• 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);
• Those with positive alcohol breath test or test value\> 0 mg / 100 ml (examination);
• Cigarette addiction (more than 10 cigarettes or the same amount of tobacco per day) within 1 month (30 days) before the first dose (inquiry);

Sponsors & Collaborators

• Changchun BCHT Biotechnology Co.: lead
• The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine: collaborator
• Anning City First People's Hospital: collaborator
• Yunnan Central Hospital: collaborator
• Beijing Contreke Statistical Technology Co., LTD: collaborator
• Military Science Zhengyuan (Beijing) Pharmaceutical Research Co., LTD: collaborator

Study Sites (1)

The First Affiliated Hospital of Yunnan University of Traditional Chinese Medicine

Kunming, Yunnan, 650000, China

Location

MeSH Terms

Conditions

Rabies

Condition Hierarchy (Ancestors)

Rhabdoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 12, 2024
• Study Start: July 31, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: August 12, 2024

Record last verified: 2024-07

Locations

CN (1)