The efficacy of specific hepatitis B virus (HBV) vaccination, in Intradermal form, in healthy carriers of HBV to eliminate virus

A randomized placebo-controlled double blind study to evaluate intradermal vaccination in hepatitis B healthy carriers to eliminate virus

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT138706131155N3

Enrollment

Registered

2008-11-10

Start date

2007-01-29

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B.

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Including hepatitis B healthy carriers (positive HBsAg with normal alanine transaminase level). Excluding D.M or other autoimmune diseases, chronic or serious medical diseases, malnutrition, positive for anti-HIV, anti-HCV and Anti-HDV, pregnancy, receiving any antiviral medication, alcohol intake daily, refusing to give informed consent and so increase in ALT or getting a serious disease during the project and volunteer refusing to continue.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Undetectable HBV-DNA. Timepoint: 6th month and 12th month. Method of measurement: PCR.;Loss of HBsAg and appearance of anti-HBs. Timepoint: 6th month and 12th month. Method of measurement: ELIZA test.	—

Secondary

Measure	Time frame
Clinical situation and possibly side effects. Timepoint: monthly. Method of measurement: clinically.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarahnaz Joukar

gastrointestinal and liver disease research center (GLDRC)

f_jokar@gums.ac.ir+98 13 1553 5116

Outcome results