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Abstract

Background

Shortly after the launch of a novel adjuvanted recombinant zoster vaccine (RZV), Shingrix, cases of suspected herpes zoster (HZ) or zoster-like skin reactions following immunisation were reported.

Aim

We aimed to investigate if these skin manifestations after administration of RZV could be HZ.

Methods

Between April and October 2020, general practitioners (GP) reporting a suspected case of HZ or zoster-like skin manifestation after RZV vaccination to the Paul-Ehrlich-Institut, the German national competent authority, were invited to participate in the study. The GP took a sample of the skin manifestation, photographed it and collected patient information on RZV vaccination and the suspected adverse event. We analysed all samples by PCR for varicella-zoster virus (VZV) and herpes-simplex virus (HSV) and genotyped VZV-positive samples. In addition, cases were independently assessed by two dermatologists.

Results

Eighty eligible cases were enrolled and 72 could be included in the analysis. Of the 72 cases, 45 were female, 33 were 60–69 years old, 32 had skin symptoms in the thoracic and 27 in the cervical dermatomes. Twenty-seven samples tested PCR positive for VZV (all genotyped as wild-type, WT), three for HSV-1 and five for HSV-2.

Conclusion

It may be difficult to distinguish HZ, without a PCR result, from other zoster-like manifestations. In this study, VZV-PCR positive dermatomal eruptions occurring in the first weeks after immunisation with RZV were due to WT VZV, which is not unexpected as HZ is a common disease against which the vaccine is unlikely to provide full protection at this time.

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This work is licensed under a Creative Commons Attribution 4.0 International License.
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/content/10.2807/1560-7917.ES.2023.28.50.2300261
2023-12-14
2024-11-21
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2023.28.50.2300261
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References

  1. Arnold N, Messaoudi I. Herpes zoster and the search for an effective vaccine. Clin Exp Immunol. 2017;187(1):82-92.  https://doi.org/10.1111/cei.12809  PMID: 27164323 
  2. International Committee on Taxonomy of Viruses (ICTV). Current ICTV Taxonomy Release. [Accessed: 5 Nov 2023]. Available from: https://ictv.global/taxonomy
  3. Kennedy PGE, Gershon AA. Clinical features of varicella-zoster virus infection. Viruses. 2018;10(11):609.  https://doi.org/10.3390/v10110609  PMID: 30400213 
  4. Cohen JI. Clinical practice: Herpes zoster. N Engl J Med. 2013;369(3):255-63.  https://doi.org/10.1056/NEJMcp1302674  PMID: 23863052 
  5. Arvin A. Aging, immunity, and the varicella-zoster virus. N Engl J Med. 2005;352(22):2266-7.  https://doi.org/10.1056/NEJMp058091  PMID: 15930416 
  6. Fleming DM, Cross KW, Cobb WA, Chapman RS. Gender difference in the incidence of shingles. Epidemiol Infect. 2004;132(1):1-5.  https://doi.org/10.1017/S0950268803001523  PMID: 14979582 
  7. Ultsch B, Siedler A, Rieck T, Reinhold T, Krause G, Wichmann O. Herpes zoster in Germany: quantifying the burden of disease. BMC Infect Dis. 2011;11(1):173.  https://doi.org/10.1186/1471-2334-11-173  PMID: 21679419 
  8. Siedler A, Koch J, Garbe E, Hengel H, von Kries R, Ledig T, et al. Background paper to the decision to recommend the vaccination with the inactivated herpes zoster subunit vaccine: Statement of the German Standing Committee on Vaccination (STIKO) at the Robert Koch Institute. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2019;62(3):352-76.  https://doi.org/10.1007/s00103-019-02882-5  PMID: 30848293 
  9. Boutry C, Hastie A, Diez-Domingo J, Tinoco JC, Yu C-J, Andrews C, et al. The adjuvanted recombinant zoster vaccine confers long-term protection against herpes zoster: interim results of an extension study of the pivotal phase 3 clinical trials ZOE-50 and ZOE-70. Clin Infect Dis. 2022;74(8):1459-67.  https://doi.org/10.1093/cid/ciab629  PMID: 34283213 
  10. Cunningham AL, Lal H, Kovac M, Chlibek R, Hwang S-J, Díez-Domingo J, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med. 2016;375(11):1019-32.  https://doi.org/10.1056/NEJMoa1603800  PMID: 27626517 
  11. Lal H, Cunningham AL, Godeaux O, Chlibek R, Diez-Domingo J, Hwang S-J, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med. 2015;372(22):2087-96.  https://doi.org/10.1056/NEJMoa1501184  PMID: 25916341 
  12. Siedler A, Koch J, Ultsch B, Garbe E, von Kries R, Ledig T, et al. , German Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI). Background paper to the decision not to recommend a standard vaccination with the live attenuated herpes zoster vaccine for the elderly in Germany: Statement of the German Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI). Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2017;60(10):1162-79.  https://doi.org/10.1007/s00103-017-2618-6  PMID: 28879392 
  13. European Medicines Agency (EMA). Zostavax: EPAR – Product Information. Amsterdam: EMA; 1 Jul 2022. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/zostavax
  14. Federal Office of Justice. Infektionsschutzgesetz. [Protection against Infection Act]. Bonn: Federal Office of Justice. [Accessed: 19 Sep 2023]. German. Available from: https://www.gesetze-im-internet.de/ifsg/__6.html
  15. Federal Office of Justice. Arzneimittelgesetz – AMG. [German Medicinal Products Act]. Bonn: Federal Office of Justice. [Accessed: 19 Sep 2023]. German. Available from: https://www.gesetze-im-internet.de/amg_1976/__4.html
  16. Arzneimittelkommission der deutschen Ärzteschaft. Fallberichte von Herpes zoster bzw. Zoster-artigen Hautläsionen nach Shingrix®-Impfung. [Case reports of herpes zoster or zoster-like skin lesions after Shingrix® vaccination]. German. Dtsch Arztebl. 2020;117(26):1356-7.
  17. Drug Commission of the German Medical Association. Drug Safety Mail 2020-27 Studie des Paul-Ehrlich-Instituts zu Shingrix® – Aufruf zur Teilnahme. [Study by the Paul Ehrlich Institute on Shingrix® – call for participation]. Berlin: Drug Commission of the German Medical Association; 20 Apr 2020. German. Available from: https://www.akdae.de/arzneimittelsicherheit/drug-safety-mail/newsdetail/drug-safety-mail-2020-27
  18. Paul-Ehrlich-Institut. Meldeformulare/Online Meldung. [Reporting forms/online reporting]. Langen: Paul-Ehrlich-Institut; 1 Oct 2021. German. Available from: https://www.pei.de/DE/arzneimittelsicherheit/pharmakovigilanz/meldeformulare-online-meldung/meldeformulare-online-meldung-node.html
  19. Copan. eSwab®: Multipurpose collection and transport system. Brescia: Copan. [Accessed: 19 Sep 2023]. Available from: https://www.copangroup.com/product-ranges/eswab
  20. altona Diagnostics. AltoStar®VZV. Hamburg: Altona. [Accessed: 19 Sep 2023]. Available from: https://www.altona-diagnostics.com/en/products/reagents/altostar-real-time-pcr-reagents.html
  21. Weidmann M, Meyer-König U, Hufert FT. Rapid detection of herpes simplex virus and varicella-zoster virus infections by real-time PCR. J Clin Microbiol. 2003;41(4):1565-8.  https://doi.org/10.1128/JCM.41.4.1565-1568.2003  PMID: 12682146 
  22. Wilson DA, Yen-Lieberman B, Schindler S, Asamoto K, Schold JD, Procop GW. Should varicella-zoster virus culture be eliminated? A comparison of direct immunofluorescence antigen detection, culture, and PCR, with a historical review. J Clin Microbiol. 2012;50(12):4120-2.  https://doi.org/10.1128/JCM.06753-11  PMID: 23035203 
  23. Mols JF, Ledent E, Heineman TC. Sampling of herpes zoster skin lesion types and the impact on viral DNA detection. J Virol Methods. 2013;188(1-2):145-7.  https://doi.org/10.1016/j.jviromet.2012.12.013  PMID: 23275023 
  24. Bezold G, Volkenandt M, Gottlöber P, Peter RU. Detection of herpes simplex virus and varicella-zoster virus in clinical swabs: frequent inhibition of PCR as determined by internal controls. Mol Diagn. 2000;5(4):279-84.  https://doi.org/10.2165/00066982-200005040-00005  PMID: 11172491 
  25. Smit PW, Heijman T, Abdallaoui ME, Bruisten SM. Comparison of collection methods for molecular detection of α-herpes viruses and Treponema pallidum, including evaluation of critical transportation conditions. Heliyon. 2019;5(4):e01522.  https://doi.org/10.1016/j.heliyon.2019.e01522  PMID: 31049433 
  26. Sauerbrei A, Rubtcova E, Wutzler P, Schmid DS, Loparev VN. Genetic profile of an Oka varicella vaccine virus variant isolated from an infant with zoster. J Clin Microbiol. 2004;42(12):5604-8.  https://doi.org/10.1128/JCM.42.12.5604-5608.2004  PMID: 15583288 
  27. Jin L, Xu S, Maple PAC, Xu W, Brown KE. Differentiation between wild-type and vaccines strains of varicella zoster virus (VZV) based on four single nucleotide polymorphisms. Epidemiol Infect. 2017;145(12):2618-25.  https://doi.org/10.1017/S0950268817001509  PMID: 28748773 
  28. World Health Organization (WHO). International Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10 Version:2019). Geneva: WHO; 2019. Available from: https://icd.who.int/browse10/2019/en
  29. Chlibek R, Smetana J, Pauksens K, Rombo L, Van den Hoek JAR, Richardus JH, et al. Safety and immunogenicity of three different formulations of an adjuvanted varicella-zoster virus subunit candidate vaccine in older adults: a phase II, randomized, controlled study. Vaccine. 2014;32(15):1745-53.  https://doi.org/10.1016/j.vaccine.2014.01.019  PMID: 24508036 
  30. Mittal N, Dhir N, Mittal N. Dermatomal rash after Shingrix vaccination: cause or coincidence? Proc Bayl Univ Med Cent. 2022;35(5):686-7.  https://doi.org/10.1080/08998280.2022.2071118  PMID: 35991721 
  31. Kohn D, Wetzig T. Zostererkrankung nach Shingrix-Impfung. [Zoster disease after Shingrix vaccination]. German. Hautarzt. 2021;72(8):729-32.  https://doi.org/10.1007/s00105-020-04738-5  PMID: 33294953 
  32. Thompson H, Nichols L, Gonzalez Santiago T. Bullous fixed drug eruption following administration of the recombinant adjuvant Shingrix vaccine. BMJ Case Rep. 2021;14(8):e241293.  https://doi.org/10.1136/bcr-2020-241293  PMID: 34413031 
  33. Bell H, Kamal N, Wong U. Blistering autoimmune skin reaction following SHINGRIX vaccination in an ulcerative colitis patient: Case report and literature review. Vaccine. 2020;38(47):7455-7.  https://doi.org/10.1016/j.vaccine.2020.09.073  PMID: 33067034 
  34. Rieck T, Steffen A, Feig M, Siedler A. Impfquoten bei Erwachsenen in Deutschland – Aktuelles aus der KV-Impfsurveillance. [Vaccination rates among adults in Germany - Latest news from the KV vaccination surveillance]. German. Epid Bull.2021;50:3-22.
Skin manifestations after immunisation with an adjuvanted recombinant zoster vaccine, Germany, 2020
<p class="citation"> <span>Citation style for this article:</span> <span class="meta-value authors"> <a href="/search?value1=Stefano+Orru%26apos%3B&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Orru&apos; Stefano</a>, <a href="/search?value1=Sibylle+Bierbaum&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Bierbaum Sibylle</a>, <a href="/search?value1=Alexander+Enk&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Enk Alexander</a>, <a href="/search?value1=Hartmut+Hengel&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hengel Hartmut</a>, <a href="/search?value1=Marcus+Hoffelner&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Hoffelner Marcus</a>, <a href="/search?value1=Daniela+Huzly&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Huzly Daniela</a>, <a href="/search?value1=Brigitte+Keller-Stanislawski&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Keller-Stanislawski Brigitte</a>, <a href="/search?value1=Vera+Mahler&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mahler Vera</a>, <a href="/search?value1=Maja+Mockenhaupt&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Mockenhaupt Maja</a>, <a href="/search?value1=Doris+Oberle&option1=author&noRedirect=true" class="nonDisambigAuthorLink">Oberle Doris</a></span>. Skin manifestations after immunisation with an adjuvanted recombinant zoster vaccine, Germany, 2020. <a href="/content/ecdc">Euro Surveill.</a> 2023;28(50):pii=2300261. <a href="https://doi.org/10.2807/1560-7917.ES.2023.28.50.2300261" title="doi link" target="_blank">https://doi.org/10.2807/1560-7917.ES.2023.28.50.2300261</a> <span class="ES_Article_citation"> <span class="generated">Received</span>: 16 May 2023;&nbsp;&nbsp; <span class="generated">Accepted</span>: 19 Sept 2023 </span> </p>
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