Evaluation of a personalized, dose-sparing revaccination strategy in hepatitis B vaccine non-responders

Christian Beulens; Stijn F H Raven; Cornelia H M van Jaarsveld; Inge van Loo; Greet Boland; Leo G Visser; Christian J P A Hoebe; Ann C T M Vossen

doi:10.1016/j.vaccine.2022.04.042

Evaluation of a personalized, dose-sparing revaccination strategy in hepatitis B vaccine non-responders

Christian Beulens, Stijn F H Raven^*, Cornelia H M van Jaarsveld, Inge van Loo, Greet Boland, Leo G Visser, Christian J P A Hoebe, Ann C T M Vossen

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

OBJECTIVES: The detection of low levels of antibodies against HBsAg (anti-HBs) below 10 IU/L in non-responders after a primary hepatitis B vaccination, is associated with seroconversion after revaccination. We compared the diagnostic performance of four anti-HBs assays in non-responders in their ability to differentiate between absence or presence of low levels of anti-HBs and propose a revaccination strategy guided by anti-HBs titres.

METHODS: Non-responders were revaccinated with Fendrix 20 μg at 0, 1 and 2 months. Anti-HBs titres were determined by Abbott Architect, Diasorin Liaison, Roche Cobas and Siemens ADVIA Centaur. Inter-assay agreement was evaluated with Cohen's Kappa (k) in baseline samples between zero-responders without detectable antibodies and poor-responders with detectable antibodies < 10 IU/L. Seroconversion rates and geometric mean titres were analysed at 0, 1 and 3 months. A titre-based strategy (one revaccination dose and anti-HBs measurement followed by two more revaccination doses if required) was compared with the standard revaccination series of 3 doses.

RESULTS: 57 participants were included in the analysis. k was ≥ 0.65 for all assays except ADVIA (k ≤ 0.41). After one revaccination dose all assays detected a mean seroconversion rate in zero-responders of 42.9%, compared to 85.1% in poor-responders. The difference between zero- and poor-responders in seroconversion rate per assay was significant (p < 0.05). After three revaccination doses the mean seroconversion rate was 88.2% in zero-responders and 98.5% in poor-responders (p > 0.286 per assay). A titre-based strategy reduced the amount of revaccinations by 17% compared with the standard.

CONCLUSIONS: All assays demonstrated a comparable difference in seroconversion rate between zero- and poor-responders after one revaccination dose. The revaccination strategy could be optimised by differentiation between zero- and poor-responders followed by a titre-guided schedule.

Original language	English
Pages (from-to)	3210-3215
Number of pages	6
Journal	Vaccine
Volume	40
Issue number	23
DOIs	https://doi.org/10.1016/j.vaccine.2022.04.042
Publication status	Published - 20 May 2022

Keywords

Hepatitis B antibodies
Hepatitis B vaccines
Hepatitis B virus
Hepatitis/prevention and control
Anti-HBs
ANTIBODY-RESPONSE
IMMUNOGENICITY
PERFORMANCE
ADULTS
ASSAYS

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10.1016/j.vaccine.2022.04.042Licence: CC BY-NC-ND

Cite this

@article{c33005900b864a22b95a0344d76ddc59,

title = "Evaluation of a personalized, dose-sparing revaccination strategy in hepatitis B vaccine non-responders",

abstract = "OBJECTIVES: The detection of low levels of antibodies against HBsAg (anti-HBs) below 10 IU/L in non-responders after a primary hepatitis B vaccination, is associated with seroconversion after revaccination. We compared the diagnostic performance of four anti-HBs assays in non-responders in their ability to differentiate between absence or presence of low levels of anti-HBs and propose a revaccination strategy guided by anti-HBs titres.METHODS: Non-responders were revaccinated with Fendrix 20 μg at 0, 1 and 2 months. Anti-HBs titres were determined by Abbott Architect, Diasorin Liaison, Roche Cobas and Siemens ADVIA Centaur. Inter-assay agreement was evaluated with Cohen's Kappa (k) in baseline samples between zero-responders without detectable antibodies and poor-responders with detectable antibodies < 10 IU/L. Seroconversion rates and geometric mean titres were analysed at 0, 1 and 3 months. A titre-based strategy (one revaccination dose and anti-HBs measurement followed by two more revaccination doses if required) was compared with the standard revaccination series of 3 doses.RESULTS: 57 participants were included in the analysis. k was ≥ 0.65 for all assays except ADVIA (k ≤ 0.41). After one revaccination dose all assays detected a mean seroconversion rate in zero-responders of 42.9%, compared to 85.1% in poor-responders. The difference between zero- and poor-responders in seroconversion rate per assay was significant (p < 0.05). After three revaccination doses the mean seroconversion rate was 88.2% in zero-responders and 98.5% in poor-responders (p > 0.286 per assay). A titre-based strategy reduced the amount of revaccinations by 17% compared with the standard.CONCLUSIONS: All assays demonstrated a comparable difference in seroconversion rate between zero- and poor-responders after one revaccination dose. The revaccination strategy could be optimised by differentiation between zero- and poor-responders followed by a titre-guided schedule.",

keywords = "Hepatitis B antibodies, Hepatitis B vaccines, Hepatitis B virus, Hepatitis/prevention and control, Anti-HBs, ANTIBODY-RESPONSE, IMMUNOGENICITY, PERFORMANCE, ADULTS, ASSAYS",

author = "Christian Beulens and Raven, {Stijn F H} and {van Jaarsveld}, {Cornelia H M} and {van Loo}, Inge and Greet Boland and Visser, {Leo G} and Hoebe, {Christian J P A} and Vossen, {Ann C T M}",

year = "2022",

month = may,

day = "20",

doi = "10.1016/j.vaccine.2022.04.042",

language = "English",

volume = "40",

pages = "3210--3215",

journal = "Vaccine",

issn = "0264-410X",

publisher = "ELSEVIER SCI LTD",

number = "23",

}

TY - JOUR

T1 - Evaluation of a personalized, dose-sparing revaccination strategy in hepatitis B vaccine non-responders

AU - Beulens, Christian

AU - Raven, Stijn F H

AU - van Jaarsveld, Cornelia H M

AU - van Loo, Inge

AU - Boland, Greet

AU - Visser, Leo G

AU - Hoebe, Christian J P A

AU - Vossen, Ann C T M

PY - 2022/5/20

Y1 - 2022/5/20

N2 - OBJECTIVES: The detection of low levels of antibodies against HBsAg (anti-HBs) below 10 IU/L in non-responders after a primary hepatitis B vaccination, is associated with seroconversion after revaccination. We compared the diagnostic performance of four anti-HBs assays in non-responders in their ability to differentiate between absence or presence of low levels of anti-HBs and propose a revaccination strategy guided by anti-HBs titres.METHODS: Non-responders were revaccinated with Fendrix 20 μg at 0, 1 and 2 months. Anti-HBs titres were determined by Abbott Architect, Diasorin Liaison, Roche Cobas and Siemens ADVIA Centaur. Inter-assay agreement was evaluated with Cohen's Kappa (k) in baseline samples between zero-responders without detectable antibodies and poor-responders with detectable antibodies < 10 IU/L. Seroconversion rates and geometric mean titres were analysed at 0, 1 and 3 months. A titre-based strategy (one revaccination dose and anti-HBs measurement followed by two more revaccination doses if required) was compared with the standard revaccination series of 3 doses.RESULTS: 57 participants were included in the analysis. k was ≥ 0.65 for all assays except ADVIA (k ≤ 0.41). After one revaccination dose all assays detected a mean seroconversion rate in zero-responders of 42.9%, compared to 85.1% in poor-responders. The difference between zero- and poor-responders in seroconversion rate per assay was significant (p < 0.05). After three revaccination doses the mean seroconversion rate was 88.2% in zero-responders and 98.5% in poor-responders (p > 0.286 per assay). A titre-based strategy reduced the amount of revaccinations by 17% compared with the standard.CONCLUSIONS: All assays demonstrated a comparable difference in seroconversion rate between zero- and poor-responders after one revaccination dose. The revaccination strategy could be optimised by differentiation between zero- and poor-responders followed by a titre-guided schedule.

AB - OBJECTIVES: The detection of low levels of antibodies against HBsAg (anti-HBs) below 10 IU/L in non-responders after a primary hepatitis B vaccination, is associated with seroconversion after revaccination. We compared the diagnostic performance of four anti-HBs assays in non-responders in their ability to differentiate between absence or presence of low levels of anti-HBs and propose a revaccination strategy guided by anti-HBs titres.METHODS: Non-responders were revaccinated with Fendrix 20 μg at 0, 1 and 2 months. Anti-HBs titres were determined by Abbott Architect, Diasorin Liaison, Roche Cobas and Siemens ADVIA Centaur. Inter-assay agreement was evaluated with Cohen's Kappa (k) in baseline samples between zero-responders without detectable antibodies and poor-responders with detectable antibodies < 10 IU/L. Seroconversion rates and geometric mean titres were analysed at 0, 1 and 3 months. A titre-based strategy (one revaccination dose and anti-HBs measurement followed by two more revaccination doses if required) was compared with the standard revaccination series of 3 doses.RESULTS: 57 participants were included in the analysis. k was ≥ 0.65 for all assays except ADVIA (k ≤ 0.41). After one revaccination dose all assays detected a mean seroconversion rate in zero-responders of 42.9%, compared to 85.1% in poor-responders. The difference between zero- and poor-responders in seroconversion rate per assay was significant (p < 0.05). After three revaccination doses the mean seroconversion rate was 88.2% in zero-responders and 98.5% in poor-responders (p > 0.286 per assay). A titre-based strategy reduced the amount of revaccinations by 17% compared with the standard.CONCLUSIONS: All assays demonstrated a comparable difference in seroconversion rate between zero- and poor-responders after one revaccination dose. The revaccination strategy could be optimised by differentiation between zero- and poor-responders followed by a titre-guided schedule.

KW - Hepatitis B antibodies

KW - Hepatitis B vaccines

KW - Hepatitis B virus

KW - Hepatitis/prevention and control

KW - Anti-HBs

KW - ANTIBODY-RESPONSE

KW - IMMUNOGENICITY

KW - PERFORMANCE

KW - ADULTS

KW - ASSAYS

U2 - 10.1016/j.vaccine.2022.04.042

DO - 10.1016/j.vaccine.2022.04.042

M3 - Article

C2 - 35469696

SN - 0264-410X

VL - 40

SP - 3210

EP - 3215

JO - Vaccine

JF - Vaccine

IS - 23

ER -