Impact of Hepatitis B Vaccination on HBs Antigenemia

NCT03193775 | Completed

• 1 other identifier: 3777
• Study Type: interventional
• Target: 220
• Locations: 0 countries
• Sites: N/A

Brief Summary

• HBV is not curable with persistent HBsAg even after the disappearance of HBV DNA.
• HBsAg \> 1000 IU/ml is associated with the risk of virological recurrence and HCC.
• There is an impaired immune response to HBsAg and HBV vaccine is an easily available, cost-effective, non-harmful method of stimulating immunity.

Conditions

HBV

Keywords

HBV vaccine; persistent; HBsAg; IP-10

Outcome Measures

Primary Outcomes (1)

• production of protective HBsAb

  Current treatment by NAs may suppress HBV replication but cannot completely eradicate the virus due to the systemic immune tolerance or exhaustion. HBV vaccine may enhance the immunity against HBsAg and may be an efficient immunotherapy in chronic HBV.

  three months after the last dose of vaccine

Secondary Outcomes (1)

• impact on Insulin resistance, fibrosis regression

  3 month after the last dose of vaccination

Study Arms (2)

chronic HBV with persistent HBsAg

ACTIVE COMPARATOR

inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia. they were given 30 µg of HBV vaccine initiated 6 months after HBe seroconversion and disappearance of HBV DNA.

Biological: HBV vaccine

control group

NO INTERVENTION

A control group (n=100) did not receive HBV vaccine

Interventions

HBV vaccine BIOLOGICAL

HBV vaccine which contains Purified HBsAg produced by recombinant DNA technology (Euvax-B, LG Life sciences, Korea) intramuscularly in deltoid region at three different time intervals (0, 1, 6 months).

chronic HBV with persistent HBsAg

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HBV patients with persistent HBs antigenemia

You may not qualify if:

• decompensated liver cirrhosis
• hepatocellular carcinoma
• other causes of liver disease or mixed causes (excessive alcohol consumption,
• autoimmune liver disease
• immunosuppressive drugs
• infection with hepatitis C virus.

Sponsors & Collaborators

• Zagazig University: lead

Related Publications (1)

• Shaaban Hanafy A. Impact of hepatitis B vaccination on HBsAg kinetics, interferon-inducible protein 10 level and recurrence of viremia. Cytokine. 2017 Nov;99:99-105. doi: 10.1016/j.cyto.2017.08.002. Epub 2017 Aug 10.

  PMID: 28802168 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Group I: inactive carriers (n=100). Group II: CHB exposed to nucleos(t)ides (n=120) till 6 months after HBe seroconversion and HBV DNA disappearance in HBeAg positive (n=60) or DNA disappearance in HBeAg negative patients (n=60). All showed persistent HBs antigenemia. -A control group (n=100) did not receive HBV vaccine

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: June 21, 2017
• Study Start: August 1, 2011
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: June 21, 2017

Record last verified: 2017-06