Chronic hepatitis B with HBeAg positive
Conditions
Interventions
vaccine group 2:30mg YIC
vaccine group 2:60mg YIC
control group:Placebo
Sponsors
National Vaccine and Serum Institute/Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Participants are agreed to sign the known agreement; 2. Age 18-65 years, without gender restriction; 3. HBsAg positive >6 months; 4. HBeAg positive, HBeAb negative, HBV-DNA PCR quantity >=105 copies/ml; 5. Without systemic antivirus treatment history; 6. ALT abnormality, >= 2 folds of normal upper limit when screening, but <=10 folds of normal upper limit; Abnormal ALT in 6 months before recruitment and more than one month interval before screening; 7. In Women of reproductive age, urine or blood pregnancy test negative. All the people of reproductive age must adopt effective contraceptive measure from enrolment until 3 months after the end of the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or breast-feeding women; 2. Vertical transmission or suspected mother-infant transmission (definition see Appendix 1); 3. Had severe chronic hepatitis in past 2 years (definition see Appendix 2); 4. Systemic or long therapy history of antiviral drug and powerful immunomodulating agents such as adrenal cortical hormone, thymic peptide-alpha 1, thymopentin; 5. With other concurrent viral infection: anti-HAV IgM, anti-HCV, anti-HDV, anti-HEV and anti-HIV, either of these is positive; 6. With allergic history to vaccination or autoimmune disease; 7. With long treatment history of liver toxic drugs in 6 months before enrolment; 8. Suspected cirrhosis or cirrhosis in compensation stage; 9. Suspected primary liver cancer or AFP>100ng/ml; 10. liver diseases with other causes: including chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibodies titer larger than l:160), hepatolenticular degeneration (Wilson's disease) and hemochoromatosis; 11. With any other severe disease, including any uncontrolled cardiac, pulmonary, renal, gastroenteral, neuropathic, mental, immunomodulating and metabolic diseases or malignant cancer with clinical significance; 12. Blood creatine >1.5 folds of normal upper limit; 13. Platelet count 2 folds of normal upper limit; 17. With evidence of drug addiction in past 1 year before enrolment (including excessive alcohol intake); 18. Participated in other clinical trial in 3 months before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| virological respons; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactDaozhen Xu
Outcome results
None listed