CompletedPhase 4ACTRN12609000616279

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?


Sponsor

Nefrologia – Faculdade de Medicina/Instituto de Pesquisas Biomedicas/Hospital Sao Lucas from PUCRS

Enrollment

198 participants

Start Date

Aug 2, 2003

Study Type

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

Sex: Both males and femalesMin Age: 20 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two methods of giving the hepatitis B vaccine (injection into the muscle versus injection into the skin) to see which produces a better immune response in people on kidney dialysis. It is for adults aged 20 and over who are new to hemodialysis treatment and have not previously been vaccinated against hepatitis B.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

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


Locations(1)

Rio Grande do Sul (RS), Brazil

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