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

Phase 4

Completed

• Conditions: Hepatitis B vaccination; Hemodialysis; Infection - Other infectious diseases; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12609000616279
• Lead Sponsor: efrologia – Faculdade de Medicina/Instituto de Pesquisas Biomedicas/Hospital Sao Lucas from PUCRS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-07-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 198

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Antibody titers to hepatitis B surface antigen (anti-HBs)[Timepoint: at baseline, 1, 2, 3, 4, 5 and 6 months after intervention commencement]

Secondary Outcome Measures

Name	Time	Method
Percentage of patients achieving immunizing titers of antibodies to hepatitis B antigen[At 6 months after intervention]