PEG-G-CSF in Non-responder Hemodialysis Patients HBs-Vaccination

Effects of Pegylated Filgrastim (PEG-G-CSF) Adjuvant on Improving Response to Hepatitis B Vaccine and HBs-Ab Serum Levels in Non-responder Chronic Hemodialysis Patients- A Randomized Double-Blind Clinical Trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20090701002113N4

Enrollment

Registered

2025-12-19

Start date

2025-12-31

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage Kidney disease. End stage renal disease

Interventions

Intervention 1: Intervention group: will receive a dose of 6 mg/0.6 mL subcutaneous PEG-G-CSF 24 hours before the first booster dose of HBV vaccine IM, and receive the other two booster doses in the 2

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Age range between 18 and 70 years Patients with dialysis adequacy 3 times a week Patients with negative serology for HBsAg, total anti-HBC, anti HCV, HIV 1 and 2 Receiving 3 IM doses of HBV vaccination and HBS-Ab titer 2.0 mg/dL, Glomerular filtration rate (GFR) <60 mL/min on hemodialysis (HD)

Exclusion criteria

Exclusion criteria: Patients with positive serology for HBsAg, total anti-HBC, anti HCV, HIV 1 and 2 Prior use of any immunomodulatory agents like steroids/vaccine adjuvants in last 6 months Receiving blood transfusion in previous 6 months Scheduled to have kidney transplantation within 3 months History of active cancer or active infection under treatment Pregnancy, childbearing potential during the study period, or breastfeeding

Design outcomes

Primary

Measure	Time frame
HBs-Ab serum levels. Timepoint: Before first vaccin booster and one month after the last two vaccine boosters (3rd, 7th months). Method of measurement: HBs-Ab serum levels will be measured by ELISA methods. 5 ml of blood will be collected in K2-EDTA tubes and HBs-Ab will be measured before PEG-G-CSF and the first vaccine booster injection, and 1 month after the last two boosters.;Response rate to hepatitis B vaccine. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Calculating the percentage change from baseline antibody levels.	—

Measure

Time frame

HBs-Ab serum levels. Timepoint: Before first vaccin booster and one month after the last two vaccine boosters (3rd, 7th months). Method of measurement: HBs-Ab serum levels will be measured by ELISA methods. 5 ml of blood will be collected in K2-EDTA tubes and HBs-Ab will be measured before PEG-G-CSF and the first vaccine booster injection, and 1 month after the last two boosters.;Response rate to hepatitis B vaccine. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Calculating the percentage change from baseline antibody levels.

—

Secondary

Measure	Time frame
Total leukocyte count. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Performing CBC Diff test for patients.;Neutrophil count. Timepoint: One month after the third booster dose (month 7 of the study period). Method of measurement: Performing CBC Diff test for patients.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Masjedi

Shiraz University of Medical Sciences

roozbehj@hotmail.com+98 71 3628 1528

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026