Intramuscular and intradermal hepatitis B vaccine administration: immunological response in hemodialysis patients

In hemodialysis patients is intradermal vaccine administration as good or better than intramuscular vaccination for hepatitis B immunization?

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000616279

Enrollment

198

Registered

2009-07-23

Start date

2003-08-02

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Hepatitis B is a viral infection that may progress to cirrhosis and liver carcinoma. Its prevalence has been estimated at 4.9% among hemodialysis patients. The vaccine applied intramuscularly (IM) to end-stage kidney disease patients, often elicits inadequate antibody titers. Additionally, intradermal (ID) vaccine inoculation into healthy individuals and hemodialysis patients seems to be effective. The study compared the responses to the two vaccine application approaches, in patients initiating hemodialysis. Hemodialysis patients were randomized to receive either 40 micrograms/dose IM vaccine or 4 micrograms/dose ID vaccine at zero, 1 and 2 months. Patients were followed for 6 months with evaluation of titers of antibodies against hepatitis B surface antigen (anti-HBs).

Interventions

Intradermal Hepatitis B vaccine, 3 times 4 micrograms doses at 0, 1 and 2 months.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

Incident chronic hemodialysis (HD) patients, with end-stage renal disease before completing the third month of HD treatment.

Exclusion criteria

Presence of antibodies against aquired immunodeficiency virus, antibodies against hepatits C, previous hepatitis B vaccination, a reagent antibody titers to hepatitis B surface antigen (Anti-HBs > 10 UI/mL).

Outcome results