Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients

Norella Kong Chiew Tong, Jiri Beran, Swee Ann Kee, Jose Luis Miguel, Carmen Sánchez, Jose Maria Bayas, A. Vilella, J. R. De Juanes, P. Arrazola, Francisco Calbo-Torrecillas, Eduardo López De Novales, Virginie Hamtiaux, Marc Lievens, Michel Stoffel

Research output: Contribution to journalArticle

141 Citations (Scopus)

Abstract

Background. Due to their impaired immune system, patients with renal insufficiency have a suboptimal response to hepatitis B (HB) vaccination and frequent boosters are needed to maintain protection. GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population. Methods. In an open, randomized clinical trial conducted in pre-hemodialysis (documented creatinine clearance ≤30 mL/min) and hemodialysis patients, over 15 years of age and naïve for HB, the immunogenicity and safety of single doses of HB-AS04 (Fendrix™, GlaxoSmithKline Biologicals) were compared to double doses of commercially available HB vaccine (Engerix™, GlaxoSmithKline Biologicals) administered at 0, 1, 2, and 6 months, and followed-up for 36 months. Results. The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population, with 74% versus 52% of subjects seroprotected at month 3. After the vaccination course, seroprotection rates increased to 91% versus 84% in the HB-AS04 and standard vaccine groups, respectively. Differences persisted up to 36 months post-vaccination (73% vs. 52%, respectively). Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points. During the follow-up, significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels (11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the standard vaccine group, respectively, P = 0.014). The HB-AS04 was more locally reactogenic than the standard immunization regimen, with pain at the injection site occurring with 41% of HB-AS04 doses versus 19% of standard vaccine doses. The occurrence of grade 3 pain was less than 1% in both groups and all events resolved within the 4-day follow-up period. Conclusion. The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid, enhanced, and longer seroprotection to these immunocompromised patients at risk for HB infection.

Original languageEnglish
Pages (from-to)2298-2303
Number of pages6
JournalKidney International
Volume68
Issue number5
DOIs
Publication statusPublished - Nov 2005
Externally publishedYes

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Hepatitis B Vaccines
Hepatitis B
Renal Dialysis
Safety
Vaccination
Vaccines
Immunocompromised Host
Pain
Population
Renal Insufficiency
Immune System
Immunization
Creatinine
Randomized Controlled Trials
hepatitis B vaccine AS04
Injections
Antibodies
Infection

Keywords

  • Adjuvant
  • HB-AS04 vaccine
  • Hemodialysis
  • Hepatitis B
  • Immunization
  • Immunogenicity
  • Reactogenicity

ASJC Scopus subject areas

  • Nephrology

Cite this

Tong, N. K. C., Beran, J., Kee, S. A., Miguel, J. L., Sánchez, C., Bayas, J. M., ... Stoffel, M. (2005). Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. Kidney International, 68(5), 2298-2303. https://doi.org/10.1111/j.1523-1755.2005.00689.x

Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. / Tong, Norella Kong Chiew; Beran, Jiri; Kee, Swee Ann; Miguel, Jose Luis; Sánchez, Carmen; Bayas, Jose Maria; Vilella, A.; De Juanes, J. R.; Arrazola, P.; Calbo-Torrecillas, Francisco; De Novales, Eduardo López; Hamtiaux, Virginie; Lievens, Marc; Stoffel, Michel.

In: Kidney International, Vol. 68, No. 5, 11.2005, p. 2298-2303.

Research output: Contribution to journalArticle

Tong, NKC, Beran, J, Kee, SA, Miguel, JL, Sánchez, C, Bayas, JM, Vilella, A, De Juanes, JR, Arrazola, P, Calbo-Torrecillas, F, De Novales, EL, Hamtiaux, V, Lievens, M & Stoffel, M 2005, 'Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients', Kidney International, vol. 68, no. 5, pp. 2298-2303. https://doi.org/10.1111/j.1523-1755.2005.00689.x
Tong, Norella Kong Chiew ; Beran, Jiri ; Kee, Swee Ann ; Miguel, Jose Luis ; Sánchez, Carmen ; Bayas, Jose Maria ; Vilella, A. ; De Juanes, J. R. ; Arrazola, P. ; Calbo-Torrecillas, Francisco ; De Novales, Eduardo López ; Hamtiaux, Virginie ; Lievens, Marc ; Stoffel, Michel. / Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients. In: Kidney International. 2005 ; Vol. 68, No. 5. pp. 2298-2303.
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T1 - Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients

AU - Tong, Norella Kong Chiew

AU - Beran, Jiri

AU - Kee, Swee Ann

AU - Miguel, Jose Luis

AU - Sánchez, Carmen

AU - Bayas, Jose Maria

AU - Vilella, A.

AU - De Juanes, J. R.

AU - Arrazola, P.

AU - Calbo-Torrecillas, Francisco

AU - De Novales, Eduardo López

AU - Hamtiaux, Virginie

AU - Lievens, Marc

AU - Stoffel, Michel

PY - 2005/11

Y1 - 2005/11

N2 - Background. Due to their impaired immune system, patients with renal insufficiency have a suboptimal response to hepatitis B (HB) vaccination and frequent boosters are needed to maintain protection. GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population. Methods. In an open, randomized clinical trial conducted in pre-hemodialysis (documented creatinine clearance ≤30 mL/min) and hemodialysis patients, over 15 years of age and naïve for HB, the immunogenicity and safety of single doses of HB-AS04 (Fendrix™, GlaxoSmithKline Biologicals) were compared to double doses of commercially available HB vaccine (Engerix™, GlaxoSmithKline Biologicals) administered at 0, 1, 2, and 6 months, and followed-up for 36 months. Results. The HB-AS04 vaccine elicited a more rapid onset of protection than the currently licensed vaccine for this particular population, with 74% versus 52% of subjects seroprotected at month 3. After the vaccination course, seroprotection rates increased to 91% versus 84% in the HB-AS04 and standard vaccine groups, respectively. Differences persisted up to 36 months post-vaccination (73% vs. 52%, respectively). Antibody concentrations were higher following the HB-AS04 vaccine at all post-vaccination time points. During the follow-up, significantly fewer subjects primed with the HB-AS04 vaccine needed a booster dose as a consequence of anti-HBs loss below seroprotective levels (11/62 subjects in the HB-AS04 group vs. 22/57 subjects in the standard vaccine group, respectively, P = 0.014). The HB-AS04 was more locally reactogenic than the standard immunization regimen, with pain at the injection site occurring with 41% of HB-AS04 doses versus 19% of standard vaccine doses. The occurrence of grade 3 pain was less than 1% in both groups and all events resolved within the 4-day follow-up period. Conclusion. The improved immunogenicity profile and clinically acceptable reactogenicity of HB-AS04 vaccine are of key importance to provide a more rapid, enhanced, and longer seroprotection to these immunocompromised patients at risk for HB infection.

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