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Trial registered on ANZCTR


Registration number
ACTRN12609000616279
Ethics application status
Approved
Date submitted
17/07/2009
Date registered
23/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intramuscular and intradermal hepatitis B vaccine administration: immunological response in hemodialysis patients
Scientific title
In hemodialysis patients is intradermal vaccine administration as good or better than intramuscular vaccination for hepatitis B immunization?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B vaccination 237313 0
Hemodialysis 237314 0
Condition category
Condition code
Infection 239615 239615 0 0
Other infectious diseases
Renal and Urogenital 239637 239637 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intradermal Hepatitis B vaccine, 3 times 4 micrograms doses at 0, 1 and 2 months.
Intervention code [1] 236966 0
Prevention
Comparator / control treatment
Intramuscular Hepatitis B vaccine, 3 times 40 micrograms doses at 0, 1 and 2 months.
Control group
Active

Outcomes
Primary outcome [1] 238401 0
Antibody titers to hepatitis B surface antigen (anti-HBs)
Timepoint [1] 238401 0
Timepoint: at baseline, 1, 2, 3, 4, 5 and 6 months after intervention commencement
Secondary outcome [1] 244872 0
Percentage of patients achieving immunizing titers of antibodies to hepatitis B antigen
Timepoint [1] 244872 0
At 6 months after intervention

Eligibility
Key inclusion criteria
Incident chronic hemodialysis (HD) patients, with end-stage renal disease before completing the third month of HD treatment.
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Series of unidentified, identical and sealed envelopes with the information IM or ID, for intramuscular or intradermal vaccination
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a raffle.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1907 0
Brazil
State/province [1] 1907 0
Rio Grande do Sul (RS)

Funding & Sponsors
Funding source category [1] 237352 0
Self funded/Unfunded
Name [1] 237352 0
Address [1] 237352 0
Country [1] 237352 0
Primary sponsor type
Other
Name
Nefrologia – Faculdade de Medicina/Instituto de Pesquisas Biomedicas/Hospital Sao Lucas from PUCRS
Address
Dr Domingos d’Avila
Nefrologia – Hospital Sao Lucas – Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Country
Brazil
Secondary sponsor category [1] 236844 0
None
Name [1] 236844 0
Address [1] 236844 0
Country [1] 236844 0
Other collaborator category [1] 768 0
Individual
Name [1] 768 0
Ana Elizabeth Prado Lima Figueiredo
Address [1] 768 0
Nefrologia - Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Country [1] 768 0
Brazil
Other collaborator category [2] 769 0
Individual
Name [2] 769 0
Carlos Abaete de los Santos
Address [2] 769 0
Nefrologia - Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Country [2] 769 0
Brazil
Other collaborator category [3] 770 0
Individual
Name [3] 770 0
Carlos Eduardo Poli de Figueiredo
Address [3] 770 0
Nefrologia - Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Country [3] 770 0
Brazil
Other collaborator category [4] 771 0
Individual
Name [4] 771 0
Regina Helena Medeiros
Address [4] 771 0
Nefrologia - Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Country [4] 771 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239480 0
Comite de Etica em Pesquisas - PUCRS
Ethics committee address [1] 239480 0
Hospital Sao Lucas da PUCRS
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Brazil
Ethics committee country [1] 239480 0
Brazil
Date submitted for ethics approval [1] 239480 0
Approval date [1] 239480 0
27/02/2003
Ethics approval number [1] 239480 0
1/03/1472

Summary
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).
Trial website
Trial related presentations / publications
1. Medeiros RH, Figueiredo AE, Poli de Figueiredo CE, d’ Avila D, de los Santos CA (2009) Intramuscular or intradermal hepatitis B vaccine administration in hemodialysis patients? American Journal of Kidney Diseases 54(5):981-982. doi:10.1053/j.ajkd.2009.07.024
Public notes

Contacts
Principal investigator
Name 29923 0
Address 29923 0
Country 29923 0
Phone 29923 0
Fax 29923 0
Email 29923 0
Contact person for public queries
Name 13170 0
Domingos d'Avila
Address 13170 0
Nefrologia – Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Brazil
Country 13170 0
Brazil
Phone 13170 0
+ 55 51 33367700
Fax 13170 0
+ 55 51 33367700
Email 13170 0
dominavila@pucrs.br
Contact person for scientific queries
Name 4098 0
Domingos d'Avila
Address 4098 0
Nefrologia – Hospital Sao Lucas - Terceiro andar.
Avenida Ipiranga 6690
Porto Alegre RS CEP 90610000
Brazil
Country 4098 0
Brazil
Phone 4098 0
+ 55 51 33367700
Fax 4098 0
+ 55 51 33367700
Email 4098 0
dominavila@pucrs.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary