Single center, randomized, double blind, active control, phase I study to evaluate the dose-tolerability, safety and immunogenicity of each 2 dose of BVN008 to healthy volunteer.

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 69

Inclusion Criteria

1)Healthy adult who voluntarily agreed to written informed consent.
2)Healthy male or female adult aged = 19-year-old and < 65-year-old at Visit 1.
3)At screening, Body Mass Index (BMI) is = 18 kg/m2 and = 30 kg/m2.
4)Subject who is able and willing to participate in compliance with the study procedures and relevant regulations during the clinical trial period.

Exclusion Criteria

1)Subject who has wounds, tattoos, scar, skin disease or infection around injection site that can affect the safety assessment.
2)Subject who has medical history of infection to diphtheria, tetanus, or pertussis prior to this study (confirmed by clinical, serum, or microbiological test).
3)Subject who has history of any other vaccination within 4 weeks prior to IP injection or has plan to receive another vaccine within 4 weeks post-vaccination of IP.
4)Subject who has received vaccine containing Anti-diphtheria, Anti-tetanus, or Anti-pertussis within 10 years prior to IP injection.
5)Subject who has experienced hypersensitivity, neurological complications, and temporary adverse reaction such as thrombocytopenia, etc. after vaccination of diphtheria, tetanus, or pertussis in the past or hypersensitivity to the other components of the vaccine.
6)Subject who experienced an unknown brain disorder within 7 days after injection of vaccine containing pertussis in the past.
7)Subject who experienced acute fever (over 38.0?) within 72 hours prior to administration of IP.
8)Subject who has a severe/serious acute/chronic or progressing disease that needs intervention within 2 weeks prior to injection of IP or a disease judged by the investigator as severe/serious acute/chronic or progressing disease which might affect the procedure of the study.
9)Subject who has a disease or medical history such as Leukemia, Lymphoma, malignant tumor or blood disorder that might affect the bone marrow or lymphatic system.
10)Subject who has progressing neurology system disorder, uncontrolled epilepsy or progressing brain disorder (subject can be enrolled in the study if the medical condition of the subject is stable under confirmed treatment, and vaccination of any Tdap vaccine is needed to avoid risk situation) or has a Guillain-Barré Syndrome.
11)At screening examination, subject who has thrombocytopenia or other disorder of coagulation, or who is receiving anticoagulation treatment due to hematoma.
12)Subject who has chronic cough prior to IP injection or has history of illness with the signs.
13)Subject who has immunodeficiency disorders (congenital immunodeficiency, cell-immunodeficiency, hypogammaglobulinemia, dysgammaglobulinemia etc.) or family history of immunodeficiency disorders.
14)At screening, the subject is tested positive for HBsAg, Anti-HCV Antibody or HCV RNA quantitative, HIV Antibody.
15)At screening, the presence of hypernatremia, hyponatremia, hypokalemia, hyperchloremia, hypoproteinemia based on the clinical laboratories as determined by investigator.
16)Subject who received 2 times of tetanus immunoglobulin 250 IU every 4 weeks interval prior to injection of IP.
17)Subject who received tetanus immunoglobulin other than blood products, blood derived products, within 12 weeks prior to injection of IP.
18)Subject who received immunomodulatory, immunosuppressant, systemic steroid within 12 weeks prior to injection of IP.
a.Including Irradiation, Antimetabolites, Alkylating agents, Cytotoxic drugs (Azathioprine, Cyclosporine, Interferon, G-CSF (Granulocyte-Colony Stimulating Factor), Tacrolimus, Everolimus, Sirolimus, etc.)
b.Using of high dose or chronic systemic corticosteroid products. Except for continuous usage of Prednisolone =20 mg/day for less than 14 days or any dosage of corticosteroid product through inhaled, nasal and topical application.
19)Subject who is of child-bearing potential and dis

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Adverse Events;2)Clinical Laboratories (Hematology/Blood Chemistry Test, Urinalysis Test);3)Vital signs (Blood pressure, pulse rate, body temperature);4)Physical Examination;5)Electrocardiogram

Secondary Outcome Measures