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Updated: Nov 22, 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 recombinant vaccines, like HBV-AS04, show improved immune response in chronic kidney disease (CKD) patients compared to standard hepatitis B vaccines. Post-vaccination antibody testing and booster doses are recommended for optimal protection.
Area of Science:
- Nephrology
- Immunology
- Vaccinology
Background:
- Chronic kidney disease (CKD) patients exhibit impaired immune responses to vaccines.
- Hepatitis B virus (HBV) infection is a significant cause of liver disease in CKD patients.
- Enhancing hepatitis B (HB) vaccine immunogenicity in CKD is crucial for preventing liver disease.
Purpose of the Study:
- To review mechanisms of reduced HBV vaccine immunogenicity in CKD.
- To identify strategies for improving HB vaccine response rates in CKD patients.
- To inform nephrologists managing CKD patients' vaccination needs.
Main Methods:
- Narrative review of studies on HBV vaccine immunogenicity in CKD.
- Assessment of recombinant vaccines, including those with adjuvants (HBV-AS02, HBV-AS04).
- Comparison of seroprotection rates and immune response durability.
Main Results:
- Adjuvanted recombinant vaccines, particularly HBV-AS04, demonstrate superior seroprotection rates in CKD patients compared to licensed vaccines.
- HBV-AS04 achieved 95% seroprotection in pre-dialysis and 82% in dialysis patients.
- HBV-AS02 showed a 76.9% seroprotection rate versus 37.6% for the licensed vaccine.
Conclusions:
- Adjuvanted recombinant vaccines (e.g., HBV-AS04) are recommended for CKD patients.
- A suggested schedule includes four doses of 20 mcg with post-vaccination antibody testing.
- Booster doses are advised for individuals with subprotective anti-HBs antibody titers (<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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