Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

Anitta Ahonen; Ying Zhang; Tomáš Marček; Jessie Lumley; David R. Johnson; Dalya Guris; Marissa B. Wilck

doi:10.1080/21645515.2022.2073747

Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

Anitta Ahonen
, Ying Zhang
, Tomáš Marček
, Jessie Lumley
, David R. Johnson
, Dalya Guris
, Marissa B. Wilck^*

^*Corresponding author for this work

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

4 Citations (Scopus)

22 Downloads (Pure)

Abstract

Vaccination against hepatitis B (HepB) provides long-term protection against infection. This is despite a reduction in HepB surface antibody (anti-HBs) concentrations over time to levels below the well-accepted correlate of protection of ≥10 mIU/mL. Continued evidence of immune memory and protection despite declined anti-HBs concentrations can be demonstrated by HepB virus surface antigen challenge studies. Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib. This phase 3, multicenter, single-group, open-label challenge study (NCT04490499; EudraCT: 2020–000126–26) evaluated immune memory against HepB infection in children who had received DTaP5-IPV-HepB-Hib at 2, 4, and 11–12 months of age, or at 2, 3, 4, and 12 months of age. At age 8–9 years, they were each challenged with 5 μg of monovalent HepB vaccine. Anti-HBs levels were measured on pre-challenge day 1 and post-challenge day 30. At baseline, 45.4% (93 of 205) had anti-HBs levels ≥10 mIU/mL. On post-challenge day 30, 99.5% (201 of 202) had anti-HBs levels ≥10 mIU/mL, regardless of initial vaccination schedule. Post-challenge, geometric mean concentrations increased 71-fold over baseline and 96.0% of children had a ≥4-fold rise in anti-HBs concentrations with similar results across both dosing schedules. The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.

Original language	English
Article number	2073747
Number of pages	7
Journal	Human Vaccines and Immunotherapeutics
Volume	18
Issue number	5
DOIs	https://doi.org/10.1080/21645515.2022.2073747
Publication status	Published - 2022
Publication type	A1 Journal article-refereed

Funding

Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck & Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript. for this research was provided by MCM Vaccine B.V., a partnership between Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Sanofi Pasteur, Inc., Swiftwater, PA, USA. Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck & Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript.

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

anamnestic response
challenge dose
Hepatitis B
hexavalent vaccine

Publication forum classification

Publication forum level 1

ASJC Scopus subject areas

Immunology and Allergy
Immunology
Pharmacology

Access to Document

10.1080/21645515.2022.2073747Licence: CC BY-NC-ND

Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5 IPV HepB Hib infant toddler series 7 to 8 years previouslyFinal published version, 1.15 MBLicence: CC BY-NC-ND

https://urn.fi/URN:NBN:fi:tuni-202302132306Licence: CC BY-NC-ND

Cite this

@article{1035d636a8244058a54f3d896aaca401,

title = "Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously",

abstract = "Vaccination against hepatitis B (HepB) provides long-term protection against infection. This is despite a reduction in HepB surface antibody (anti-HBs) concentrations over time to levels below the well-accepted correlate of protection of ≥10 mIU/mL. Continued evidence of immune memory and protection despite declined anti-HBs concentrations can be demonstrated by HepB virus surface antigen challenge studies. Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib. This phase 3, multicenter, single-group, open-label challenge study (NCT04490499; EudraCT: 2020–000126–26) evaluated immune memory against HepB infection in children who had received DTaP5-IPV-HepB-Hib at 2, 4, and 11–12 months of age, or at 2, 3, 4, and 12 months of age. At age 8–9 years, they were each challenged with 5 μg of monovalent HepB vaccine. Anti-HBs levels were measured on pre-challenge day 1 and post-challenge day 30. At baseline, 45.4\% (93 of 205) had anti-HBs levels ≥10 mIU/mL. On post-challenge day 30, 99.5\% (201 of 202) had anti-HBs levels ≥10 mIU/mL, regardless of initial vaccination schedule. Post-challenge, geometric mean concentrations increased 71-fold over baseline and 96.0\% of children had a ≥4-fold rise in anti-HBs concentrations with similar results across both dosing schedules. The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.",

keywords = "anamnestic response, challenge dose, Hepatitis B, hexavalent vaccine",

author = "Anitta Ahonen and Ying Zhang and Tom{\'a}{\v s} Mar{\v c}ek and Jessie Lumley and Johnson, \{David R.\} and Dalya Guris and Wilck, \{Marissa B.\}",

note = "Funding Information: Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck \& Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript. Funding Information: for this research was provided by MCM Vaccine B.V., a partnership between Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA, and Sanofi Pasteur, Inc., Swiftwater, PA, USA. Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp \& Dohme LLC, a subsidiary of Merck \& Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck \& Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript. Publisher Copyright: {\textcopyright} 2022 Merck \& Co., Inc. Published with license by Taylor \& Francis Group, LLC.",

year = "2022",

doi = "10.1080/21645515.2022.2073747",

language = "English",

volume = "18",

journal = "Human Vaccines and Immunotherapeutics",

issn = "2164-5515",

publisher = "American School of Classical Studies at Athens",

number = "5",

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T1 - Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

AU - Ahonen, Anitta

AU - Zhang, Ying

AU - Marček, Tomáš

AU - Lumley, Jessie

AU - Johnson, David R.

AU - Guris, Dalya

AU - Wilck, Marissa B.

N1 - Funding Information: Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck & Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript. Funding Information: for this research was provided by MCM Vaccine B.V., a partnership between Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and Sanofi Pasteur, Inc., Swiftwater, PA, USA. Medical writing and/or editorial assistance was provided by Susan E. DeRocco, PhD, CMPP, and Madiha Khan, PharmD, of The Lockwood Group, Stamford, CT, USA. This assistance was funded by Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA, and MCM Vaccine B. V., Leiden, The Netherlands. We would also like to thank Michelle Goveia, MD, MPH, of Merck & Co., Inc., Kenilworth, NJ, USA, for her contributions to this manuscript. Publisher Copyright: © 2022 Merck & Co., Inc. Published with license by Taylor & Francis Group, LLC.

PY - 2022

Y1 - 2022

N2 - Vaccination against hepatitis B (HepB) provides long-term protection against infection. This is despite a reduction in HepB surface antibody (anti-HBs) concentrations over time to levels below the well-accepted correlate of protection of ≥10 mIU/mL. Continued evidence of immune memory and protection despite declined anti-HBs concentrations can be demonstrated by HepB virus surface antigen challenge studies. Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib. This phase 3, multicenter, single-group, open-label challenge study (NCT04490499; EudraCT: 2020–000126–26) evaluated immune memory against HepB infection in children who had received DTaP5-IPV-HepB-Hib at 2, 4, and 11–12 months of age, or at 2, 3, 4, and 12 months of age. At age 8–9 years, they were each challenged with 5 μg of monovalent HepB vaccine. Anti-HBs levels were measured on pre-challenge day 1 and post-challenge day 30. At baseline, 45.4% (93 of 205) had anti-HBs levels ≥10 mIU/mL. On post-challenge day 30, 99.5% (201 of 202) had anti-HBs levels ≥10 mIU/mL, regardless of initial vaccination schedule. Post-challenge, geometric mean concentrations increased 71-fold over baseline and 96.0% of children had a ≥4-fold rise in anti-HBs concentrations with similar results across both dosing schedules. The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.

AB - Vaccination against hepatitis B (HepB) provides long-term protection against infection. This is despite a reduction in HepB surface antibody (anti-HBs) concentrations over time to levels below the well-accepted correlate of protection of ≥10 mIU/mL. Continued evidence of immune memory and protection despite declined anti-HBs concentrations can be demonstrated by HepB virus surface antigen challenge studies. Long-term immune memory and protection against HepB infection has not been demonstrated previously for the pediatric hexavalent vaccine DTaP5-IPV-HepB-Hib. This phase 3, multicenter, single-group, open-label challenge study (NCT04490499; EudraCT: 2020–000126–26) evaluated immune memory against HepB infection in children who had received DTaP5-IPV-HepB-Hib at 2, 4, and 11–12 months of age, or at 2, 3, 4, and 12 months of age. At age 8–9 years, they were each challenged with 5 μg of monovalent HepB vaccine. Anti-HBs levels were measured on pre-challenge day 1 and post-challenge day 30. At baseline, 45.4% (93 of 205) had anti-HBs levels ≥10 mIU/mL. On post-challenge day 30, 99.5% (201 of 202) had anti-HBs levels ≥10 mIU/mL, regardless of initial vaccination schedule. Post-challenge, geometric mean concentrations increased 71-fold over baseline and 96.0% of children had a ≥4-fold rise in anti-HBs concentrations with similar results across both dosing schedules. The challenge dose was well tolerated. The robust anti-HBs responses after a single 5-μg dose of HepB vaccine confirm the persistence of a HepB immune memory and demonstrate that DTaP5-IPV-HepB-Hib provides long-term protection against HepB.

KW - anamnestic response

KW - challenge dose

KW - Hepatitis B

KW - hexavalent vaccine

U2 - 10.1080/21645515.2022.2073747

DO - 10.1080/21645515.2022.2073747

M3 - Article

C2 - 35653552

AN - SCOPUS:85131412194

SN - 2164-5515

VL - 18

JO - Human Vaccines and Immunotherapeutics

JF - Human Vaccines and Immunotherapeutics

IS - 5

M1 - 2073747

ER -

Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously

Abstract

Funding

UN SDGs

Keywords

Publication forum classification

ASJC Scopus subject areas

Access to Document

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Cite this