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Updated: Aug 27, 2025

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
Hepatitis B virus vaccine and chronic kidney disease. The advances
Fabrizio Fabrizi1, Roberta Cerutti1, Vivek Dixit2
1IRCCS Ca' Granda Foundation and Maggiore Polyclinic Hospital, Milano, Italy.
Insights
Adjuvanted Hepatitis B vaccines, like HBV-AS04, show improved immune response in chronic kidney disease (CKD) patients. Post-vaccination antibody testing and booster doses are recommended for CKD patients receiving the HBV vaccine.
Area of Science:
- Nephrology
- Immunology
- Vaccinology
Background:
- Chronic kidney disease (CKD) is linked to liver disease and impaired immune responses to vaccines.
- Hepatitis B virus (HBV) infection is a significant concern for CKD patients.
- Optimal strategies to enhance HBV vaccine immunogenicity in CKD patients are needed.
Purpose of the Study:
- To review the mechanisms behind reduced HBV vaccine effectiveness in CKD patients.
- To assess various approaches for improving HBV vaccine response rates in this population.
Main Methods:
- A narrative review of existing research on HBV vaccine immunogenicity in CKD.
- Analysis of clinical trials and observational studies on recombinant HBV vaccines, including adjuvanted formulations.
Main Results:
- Adjuvanted recombinant vaccines (HBV-AS04, HBV-AS02) demonstrate superior seroprotection rates compared to licensed vaccines in CKD patients.
- HBV-AS04 achieved high seroprotection rates (95% in pre-dialysis, 82% in dialysis patients).
- HBV-AS02 showed a seroprotection rate of 76.9% versus 37.6% for the licensed vaccine.
Conclusions:
- Adjuvanted recombinant HBV-AS04 vaccine, administered on a modified schedule (0, 1, 2, 3 months; 20 mcg doses), is recommended for CKD patients.
- Post-vaccination anti-HBs antibody testing is crucial for monitoring immune response.
- Booster doses should be administered if antibody titers fall below protective levels (<10 IU/mL).
Background:
Hepatitis B is an important agent of liver disease in patients with chronic kidney disease and chronic HBV infection promotes the development of CKD in the adult general population. Patients with CKD have a suboptimal response to various vaccines, and it remains unclear how we boost the immune response of CKD patients to HB vaccine.
Study Aims And Design:
We performed a narrative review to assess the mechanisms of lower immunogenicity of HBV vaccine in CKD population; multiple approaches to improve the response rate of CKD patients to HBV vaccine have been reported. This is a very important topic for nephrologists who often serve as primary case providers for patients with CKD.
Results:
The recommended vaccine schedule for CKD patients including those on maintenance dialysis is based on recombinant vaccine, four doses (month 0,1,2, and 6; 40mcg each) by intramuscular route (deltoid muscle). According to RCTs or observational studies, some recombinant vaccines with adjuvants (i.e., HBV-AS02 and HBV-AS04) look promising. HBV-AS04 showed to give better seroprotection rates and durable immune response over extended follow-ups compared with licensed HBV vaccine in CKD patients. The seroprotection rate was 95% (97/102) and 82% (202/248) in pre-dialysis and dialysis patients, respectively, one month after completing vaccine schedule with HBV-AS04. HBV-AS02 was superior to licensed vaccine in terms of seroprotection rate, 76.9% vs. 37.6%.
Conclusions:
We suggest adjuvanted recombinant (HBV-AS04) vaccine (0,1,2 and 3 months; 20 mcg each dose) and post vaccination testing of anti-HBs antibody after vaccination. Booster doses to patients whose anti-HBs titers fall below the seroprotection level (<10IU/mL) during the follow-up are appropriate. The patho-physiologic mechanisms responsible for the poor immunogenicity of HBV vaccine in CKD patients are under active investigation.
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