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?
Nefrologia – Faculdade de Medicina/Instituto de Pesquisas Biomedicas/Hospital Sao Lucas from PUCRS
198 participants
Aug 2, 2003
Interventional
Conditions
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).
Eligibility
Inclusion Criteria1
- Incident chronic hemodialysis (HD) patients, with end-stage renal disease before completing the third month of HD treatment.
Exclusion Criteria1
- 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).
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Interventions
Intradermal Hepatitis B vaccine, 3 times 4 micrograms doses at 0, 1 and 2 months.
Locations(1)
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ACTRN12609000616279