The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study)

The Efficacy of Hepatitis B Virus (HBV) Vaccination in Patients with Previously Resolved HBV Infection Receiving Immunosuppressive Therapy to Prevent HBV Reactivation through Increase of Serum Levels of Anti-HBs (Pilot Study) - Hepatitis B Virus Vaccination to Prevent HBV Reactivation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000042288

Enrollment

Registered

2020-10-30

Start date

2020-10-30

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Collagen disease, collagen disease related disease, ulcerative colitis, Crohn&#39

Interventions

HBV vaccines at a volume of 0.5 mL are administrated by intramuscular injection for 3 times at baseline and 4 and 20 weeks later. If anti-HBs titer is less than 10 mIU /mL after vaccinations, HBV vac

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients tested positive for serum anti-HBs and/or anti-HBc despite of a negative serum HBs-antigen status. Patients receiving immunosuppressive therapy.

Exclusion criteria

Exclusion criteria: Patients after HB vaccination. Patients who have had allergic symptoms due to vaccination. Patients with serious infections. Pregnant and lactating women. Patients judged by the attending physician to be ineligible.

Design outcomes

Primary

Measure	Time frame
The percentages of patients showing anti-HBs titer rises above the baseline and 10 mIU / ml or more at 4-8 weeks after vaccination among the patients received the vaccination during immunosuppressive therapy.	—

Countries

Japan

Contacts

Public ContactSatoshi Mochida

Saitama Medical University Department of Gastroenterology and Hepatology

smochida@saitama-med.ac.jp049-276-1198

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026