Chronic Hepatitis b, Hepatitis B Vaccine
Conditions
Brief summary
Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations will be conducted every 3-6 months, and blood samples will be retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.
Detailed description
Collect basic information of patients before antiviral treatment and when HBsAg disappears, and divide them into three groups A, B, and C based on baseline anti HBs titers after informed consent. Group A has an anti HBs titer ≥ 100mIU/ml and is followed up every 3-6 months for observation. The anti HBs titers\<100mIU/ml were randomly divided into two groups: Group B and Group C. Group B did not intervene and was followed up every 3-6 months for observation; In group C, 20 micrograms of recombinant hepatitis B vaccine were injected subcutaneously three times on day 0, January and March. For group C patients, the level of anti HBs was detected at the 4th month after the initial vaccination. For those who could not produce anti HBs (anti HBs\<10mIU/ml), the recombinant hepatitis B vaccine was subcutaneously injected three times, 20 μ g each time, in 0 day, January and March. During the follow-up period of all patients, clinical biochemistry, virology (HBVDNA, HBVRNA), serological indicators (HBsAg, anti HBs, HBeAg, anti HBe, HBcrAg, anti HBc), AFP, Fibroscan, liver imaging examinations were conducted every 3-6 months, and blood samples were retained for monitoring the frequency of immune cells (pDC, Treg) and the expression of functional molecules, as well as cytokines (IFN - γ, IP-10, IL-10, and TGF - β). Observe the sustained response rate and recurrence rate of virological and serological indicators, as well as the incidence of hepatitis and liver cancer during the follow-up period.
Interventions
BIOLOGICALbaseline anti-HBs titer
Patients with baseline anti-HBs titer\<100 mIU/ml were randomly divided into two groups, group B and group C. Group B did not intervene, while group C received hepatitis B vaccine intervention and observed its indicators.
Sponsors
Beijing Municipal Administration of Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 65 years old; * Gender is not limited; * CHB patients who meet the diagnostic criteria of the 2019 edition of the Guidelines for the Prevention and Treatment of Chronic Hepatitis B \[5\]; * Confirmed interferon treatment resulted in HBsAg disappearance, HBeAg negativity, and HBV DNA below the lower detection limit and cessation Patients treated with interferon; * Sign a written informed consent form.
Exclusion criteria
* Merge with other hepatitis virus (HCV, HDV) infections; * Autoimmune liver disease; * HIV infection; * Long term alcohol abuse and/or other liver damaging drugs; * Mental illness; * Evidence of liver tumors (liver cancer or AFP\>100ng/ml); * Decompensated cirrhosis; * Individuals with serious diseases of the heart, brain, lungs, kidneys, and other systems who cannot participate in long-term follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sustained response rate and relapse rate by virological and serological indicators | Conduct testing every 3-6 months | The levels of biochemical, AFP, HBV DNA, HBV RNA, HBsAg, anti-HBs, HBeAg, anti-He, anti-He, HBcrAg and anti-HBc measured the expression of frequency and functional molecules of peripheral blood pDC and Treg cells and the plasma levels of IFN- γ, IP-10, IL-10 and TGF- β |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hepatitis and liver cancer | 36 months | The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process The incidence of hepatitis and liver cancer among the enrolled researchers during the research process. |
Countries
China
Contacts
Primary ContactLu Zhang
Outcome results
None listed