Plague
Conditions
Interventions
Low-dose plague vaccine:2 dose for 2 weeks interval
Medium-dose plague vaccine:2 dose for 2 weeks interval
High-dose plague vaccine:2 dose for 2 weeks interval
Sponsors
Lanzhou Institute of Biological Products Company Limited
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: (1)Aged between 18-55 years (inclusive) on Day 0 of the Study;(2)Volunteers are diagnosed healthy from asking about the medical history, phisical examination, and clinical judgement;(3)Able to understand the informed consent form and willing to give signed informed consent;(4)Able to obey the requirment of clinical trial protocols;(5)Temperature of oxter =37.0?.
Exclusion criteria
Exclusion criteria: (1)Family history or medical history of irritability, convulsions, seizures, encephalopathy and mental disease; (2)History of plague exposure or disease or previous vaccination with any plague vaccine; (3)History of allergy to any ingredient of the vaccine(e.g., protein, aluminium hydroxide, Thiomersal; (4)Known to have immunosuppressive or immunodeficiency; (5)Serious chronic illness,congenital monstrosity, or eccyliosis; (6)Thrombocytopenia or disturbance of blood coagulation diseases; (7)Immunosuppressive therapy, antianaphylactic treatment, cytotoxic therapy, and inhale corticosteroids(Corticosteroid spray in treatment of allergic rhinitis and Surface corticosteroid treatment of acute non concurrent dermatitis not inclusive)in the past six months; (8)Hard to collect blood; (9)Recipent of blood product 3 months prior to vaccination; (10)Receipted other research medicine in past 30 days before vaccination; (11)Receipted live attenuated vaccine in past 4 weeks before vaccination; (12)Receipted sub-unit vaccine or inactivated vaccine in past 2 weeks before vaccination; (13)Acute febrile illness or active infection; (14)For medical, psychological, social or other conditions, alien to trial protocol or affect signment of informed consent, determined by the Investigator; Secondary dosage exclusion criteria: Adverse events following below appear, secondary dosage vaccination forbiddened; Any adverse events following below appears, the volunteers can recevie the vaccine, but the volunteers can proceed other research steps, determined by the investgator. Volunteers must be followed up until the problem solved if any adverse events appears: (1)Any adverse events maybe related to the vaccination; (2)Hypersensitivity(urticaria/rash appears 30 minutes prior to vaccination inclusive)after vaccination; (3)Anaphylaxis after vaccination; (4)Any confirmed or suspected auto-immune diseases or immune-deficient diseases, HIV infection included; (5)Acute or new chronic disease in the time of vaccination,the investigator determine whether to proceed or not; (6)The investigator determine whether the trial can proceed when some reactivity appear(including severe pain, severe swelling, serious limitation of activity, prolonged high fever, awful headaches or other systemic and local reactions); (7)Following adverse reactions belong to contraindications of the plague vaccine vaccination, volunteers can delay the protocol or quit by the investigator judgement if the following adverse reactions appear after vaccination; ? Volunteers suffering acute disease while vaccination(Acute disease is associated with or without fever of moderate or severe diseases); ? Vaccination axillary temperature>37.0°C.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicator; | — |
Countries
China
Contacts
Public ContactHu YueMei
Outcome results
None listed