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HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population - 29/01/20

Doi : 10.1016/j.clinre.2019.06.010 
Fabrizio Fabrizi a, , Roberta Cerutti a, Luca Nardelli a, Federica Tripodi a, Piergiorgio Messa a, b
a Division of Nephrology, Milan, Italy 
b Maggiore Hospital and IRCCS Foundation, University School of Medicine, Milan, Italy 

Corresponding author. Division of Nephrology, Maggiore Hospital, IRCCS Foundation, Pad. Croff, Via Commenda 15, 20122 Milano, Italy.Division of Nephrology, Maggiore Hospital, IRCCS FoundationPad. Croff, Via Commenda 15Milano20122Italy

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Highlights

The immunological response to hepatitis B virus vaccine in patients with chronic kidney disease is unsatisfactory due to the immune compromise from chronic uraemia.
A recombinant HB vaccine containing an adjuvant has been adopted (HBV-AS04) in order to improve the immune response in CKD population but the available evidence on this point is extremely limited.
The current evidence regards mostly patients on long-term dialysis who received HBV-AS04; we have conducted a prospective study (‘real-life’ practice) to assess immunogenicity and safety of HBV-AS04 in pre-dialysis CKD population.
The seroprotection (HBsAb>10mIU/mL) rate was 95% (97/102), according to per-protocol analysis; no major side effects were found.
It appears that HBV-AS04 is really an advance as it gives great seroprotection rates in CKD population.
We need studies provided with longer follow-ups to evaluate the immunological response in CKD patients after completion of HBV-AS04 vaccine course.

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Summary

Background

Patients with chronic kidney disease have a poor response to hepatitis B vaccine due to the immunodeficiency conferred from chronic uremia. A recombinant HB vaccine containing an improved adjuvant system AS04 (HBV-AS04) has been manufactured but scarce evidence exists on HBV-AS04 use among patients with CKD.

Aim

To assess efficacy and safety of an adjuvanted recombinant vaccine (HBV-AS04) in a large cohort of CKD patients at pre-dialysis stage (with susceptibility to HBV infection).

Methods

Patients were prospectively enrolled to receive four 20-mcg doses of HBV-AS04 by intramuscular route (deltoid muscle) at months 1, 2, 3, and 4. Anti-HBs surface antibody concentrations were tested at intervals of 1, 2, 3, 4, and 12months. Multivariate analyses were performed to assess the parameters, which predicted immunologic response to HBV-AS04 vaccine.

Results

One hundred and seven patients were included and 102 completed the study. At completion of vaccine schedule, the frequency of responders (anti-HBs titers10mIU/mL) was 95% (97/102) (mean anti-HBs antibody titers, 688.9±385mIU/mL), according to per-protocol analysis. Serum haemoglobin levels were greater in responder than non- or low-responder patients to HBV-AS04 (P=0.04) and this was confirmed by multivariate analysis. The seroprotection rate at month 50 was 88% (30/34) with lower anti-HBs antibody titers (218.5±269.6mIU/mL, P=0.001). No major side effects were observed.

Conclusions

Our prospective study performed in a real-world setting showed a high immunogenicity and safety of HBV-AS04 vaccine in patients with CKD not yet on maintenance dialysis. Studies provided with longer follow-ups are under way to assess the durability of seroprotection in responders.

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Keywords : Adjuvant, Hepatitis B vaccine, Chronic kidney disease, Immunogenicity, Safety


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Vol 44 - N° 1

P. 49-56 - février 2020 Retour au numéro
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