HBV vaccination with Fendrix is effective and safe in pre-dialysis CKD population - 29/01/20
, Roberta Cerutti a, Luca Nardelli a, Federica Tripodi a, Piergiorgio Messa a, bBienvenido a EM-consulte, la referencia de los profesionales de la salud.
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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. |
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 titers≥10mIU/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.
El texto completo de este artículo está disponible en PDF.Keywords : Adjuvant, Hepatitis B vaccine, Chronic kidney disease, Immunogenicity, Safety
Esquema
Vol 44 - N° 1
P. 49-56 - février 2020 Regresar al número
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Bienvenido a EM-consulte, la referencia de los profesionales de la salud.
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