Hepatitis B
Conditions
Interventions
Experimental group:inoculate recombinant vaccine (hansenula polymorpha) Hepatitis B Vaccine (CpG ODN adjuvant)
control group:inoculate recombinant vaccine (hansenula polymorpha) Hepatitis B Vaccine
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Healthy subjects aged 18-60 years, the HBV infection screening indicators (HBsAg, anti-HBs, anti-HBc) are negative by laboratory testing, and the screening indicators of liver and kidney function are normal; 2. The subjects know this vaccine, volunteer to participate in the study and sign the informed consent; 3. The subjects can and will comply with the requirements of the protocol, adhere to follow-up 8 months, the subjects are able to use of the thermometers, scales and fill out the form and card of this study; 4. The subjects can undergo the blood tests according to the requirements of the protocol; 5. Had never vaccinated other prevention products within one month; 6. The axillary temperature is 37.0 degree or less.
Exclusion criteria
Exclusion criteria: 1. Participants who had history of serious allergy to any vaccine or drug , or fever with higher than 39.0 after inoculate prevention biological products previously; 2. Participants who had history of epilepsy, seizures, encephalopathy, or family history of mental illness; 3. Participants who had history of the diagnosis thrombocytopenia, or other coagulation disorders; 4. Participants who had received non-specific human serum gamma globulin within three-month injection; 5. Participants who had known or suspected immunological dysfunction, including immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, anti-metabolites or cytotoxic drugs), HIV infection; 6. Participants who are suffering from serious chronic diseases, severe malnutrition, infectious diseases, active infection and liver disease, kidney disease, cardiovascular disease; 7. Participants who had severe asthma; 8. Participants who are suffering from generalized skin rash, psoriasis, purulent skin or blisters; 9. Female Participants who are pregnant (urine test positive), breast-feeding, or they are planning a pregnancy within 7 months; 10. participate in another clinical trials of some drug; 11. Any circumstances that in the opinion of researchers, may interfere with the assessment of the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentages of subjects reporting adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-HBs neutralizing antibody concentration; | — |
Countries
China
Contacts
Public ContactHuakun Lv
Zhejiang Provincial Center for Disease Control and Prevention
Outcome results
None listed