The Effect of Granulocyte Colony Stimulating Factor (GCSF) on Immune Response to Hepatitis B Vaccine in End-Stage Renal Disease (ESRD) Patients Undergoing Hemodialysis

The titer of Anti HBS Ab in hemodialysis patients receiving double dose HBV vaccine and simultaneous granulocyte-colony stimulating factor (G-CSF) is higher compared to hemodialysis patients receiving only double dose HBV vaccine

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000246987

Enrollment

100

Registered

2011-03-07

Start date

2011-04-01

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

Adminstration of GM-CSM along with vaccination against HBV may increase immunity and higher titers of antibody

Interventions

Intramuscular injection of double dose of HBV vaccine (40 micro gr) and simultaneous injection of Granolocyte monocyte colony stimulating factor (GM-CSF) (300 micro gr). 3 doses of HBV vaccine at months 0,1 and 4 will be injected. GM-CSF will be administered after each injection of HBV vaccine.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

End stage renal disease (ESRD) patients on hemodialysis

Exclusion criteria

1. Previous history of viral hepatitis (HBS POSITIVE OR anti HBC Ab positive 2. HIV and HCV positive patients 3. Those patients who has history of vaccination 4. Patients with chronic liver disease 5. Patients with congestive heart failure (class III and IV) 6. Patients with chronic lung disease 7. Patients with hypersensitivity to GM-CSF

Outcome results