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Meta-Analysis
. 2019 Nov 7;2019(11):CD008858.
doi: 10.1002/14651858.CD008858.pub4.

Vaccines for preventing herpes zoster in older adults

Anna Mz Gagliardi  1 , Brenda Ng Andriolo  2 , Maria Regina Torloni  2 , Bernardo Go Soares  3 , Juliana de Oliveira Gomes  1 , Regis B Andriolo  4 , Eduardo Canteiro Cruz  1
Affiliations
Meta-Analysis

Vaccines for preventing herpes zoster in older adults

Anna Mz Gagliardi et al. Cochrane Database Syst Rev. .

Update in

  • Vaccines for preventing herpes zoster in older adults.
    de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. de Oliveira Gomes J, et al. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5. Cochrane Database Syst Rev. 2023. PMID: 37781954 Free PMC article.

Abstract

Background: Herpes zoster, commonly known as shingles, is a neurocutaneous disease caused by the reactivation of the virus that causes varicella (chickenpox). After resolution of the varicella episode, the virus can remain latent in the sensitive dorsal ganglia of the spine. Years later, with declining immunity, the varicella zoster virus (VZV) can reactivate and cause herpes zoster, an extremely painful condition that can last many weeks or months and significantly compromise the quality of life of the affected person. The natural process of aging is associated with a reduction in cellular immunity, and this predisposes older people to herpes zoster. Vaccination with an attenuated form of the VZV activates specific T-cell production avoiding viral reactivation. The USA Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus, live zoster vaccine (LZV), for clinical use amongst older adults, which has been tested in large populations. A new adjuvanted recombinant VZV subunit zoster vaccine, recombinant zoster vaccine (RZV), has also been approved. It consists of recombinant VZV glycoprotein E and a liposome-based AS01B adjuvant system. This is an update of a Cochrane Review last updated in 2016.

Objectives: To evaluate the effectiveness and safety of vaccination for preventing herpes zoster in older adults.

Search methods: For this 2019 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 1, January 2019), MEDLINE (1948 to January 2019), Embase (2010 to January 2019), CINAHL (1981 to January 2019), LILACS (1982 to January 2019), WHO ICTRP (on 31 January 2019) and ClinicalTrials.gov (on 31 January 2019).

Selection criteria: We included randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine (any dose and potency) versus any other type of intervention (e.g. varicella vaccine, antiviral medication), placebo, or no intervention (no vaccine). Outcomes were incidence of herpes zoster, adverse events (death, serious adverse events, systemic reactions, or local reaction occurring at any time after vaccination), and dropouts.

Data collection and analysis: We used standard methodological procedures expected by Cochrane.

Main results: We included 11 new studies involving 18,615 participants in this update. The review now includes a total of 24 studies involving 88,531 participants. Only three studies assessed the incidence of herpes zoster in groups that received vaccines versus placebo. Most studies were conducted in high-income countries in Europe and North America and included healthy Caucasians (understood to be white participants) aged 60 years or over with no immunosuppressive comorbidities. Two studies were conducted in Japan. Fifteen studies used LZV. Nine studies tested an RZV. The overall quality of the evidence was moderate. Most data for the primary outcome (incidence of herpes zoster) and secondary outcomes (adverse events and dropouts) came from studies that had a low risk of bias and included a large number of participants. The incidence of herpes zoster at up to three years follow-up was lower in participants who received the LZV (one dose subcutaneously) than in those who received placebo (risk ratio (RR) 0.49, 95% confidence interval (CI) 0.43 to 0.56; risk difference (RD) 2%; number needed to treat for an additional beneficial outcome (NNTB) 50; moderate-quality evidence) in the largest study, which included 38,546 participants. There were no differences between the vaccinated and placebo groups for serious adverse events (RR 1.08, 95% CI 0.95 to 1.21) or deaths (RR 1.01, 95% CI 0.92 to 1.11; moderate-quality evidence). The vaccinated group had a higher incidence of one or more adverse events (RR 1.71, 95% CI 1.38 to 2.11; RD 23%; number needed to treat for an additional harmful outcome (NNTH) 4.3) and injection site adverse events (RR 3.73, 95% CI 1.93 to 7.21; RD 28%; NNTH 3.6) of mild to moderate intensity (moderate-quality evidence). These data came from four studies with 6980 participants aged 60 years or over. Two studies (29,311 participants for safety evaluation and 22,022 participants for efficacy evaluation) compared RZV (two doses intramuscularly, two months apart) versus placebo. Participants who received the new vaccine had a lower incidence of herpes zoster at 3.2 years follow-up (RR 0.08, 95% CI 0.03 to 0.23; RD 3%; NNTB 33; moderate-quality evidence). There were no differences between the vaccinated and placebo groups in incidence of serious adverse events (RR 0.97, 95% CI 0.91 to 1.03) or deaths (RR 0.94, 95% CI 0.84 to 1.04; moderate-quality evidence). The vaccinated group had a higher incidence of adverse events, any systemic symptom (RR 2.23, 95% CI 2.12 to 2.34; RD 33%; NNTH 3.0), and any local symptom (RR 6.89, 95% CI 6.37 to 7.45; RD 67%; NNTH 1.5). Although most participants reported that there symptoms were of mild to moderate intensity, the risk of dropouts (participants not returning for the second dose, two months after the first dose) was higher in the vaccine group than in the placebo group (RR 1.25, 95% CI 1.13 to 1.39; RD 1%; NNTH 100, moderate-quality evidence). Only one study reported funding from a non-commercial source (a university research foundation). All of the other included studies received funding from pharmaceutical companies. We did not conduct subgroup and sensitivity analyses AUTHORS' CONCLUSIONS: LZV and RZV are effective in preventing herpes zoster disease for up to three years (the main studies did not follow participants for more than three years). To date, there are no data to recommend revaccination after receiving the basic schedule for each type of vaccine. Both vaccines produce systemic and injection site adverse events of mild to moderate intensity.

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Conflict of interest statement

Anna MZ Gagliardi: none known Brenda NG Andriolo: none known Maria R Torloni: none known Bernardo GO Soares: none known Juliana O Gomes: none known Regis B Andriolo: none known Eduardo C Cruz: none known

Figures

1
1
Study flow diagram 2019 update.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 1 Incidence of herpes zoster.
1.2
1.2. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 2 Interference of herpes zoster in activities of daily life.
1.3
1.3. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 3 Participants with adverse events.
1.4
1.4. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 4 Duration in days of adverse effects.
1.5
1.5. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 5 Dropouts.
1.6
1.6. Analysis
Comparison 1 Live zoster vaccine versus placebo, Outcome 6 Participants with no follow‐up.
2.1
2.1. Analysis
Comparison 2 Recombinant zoster vaccine versus placebo, Outcome 1 Incidence of herpes zoster at least 3.2 years follow‐up.
2.2
2.2. Analysis
Comparison 2 Recombinant zoster vaccine versus placebo, Outcome 2 Incidence of herpes zoster at least 4 years follow‐up.
2.3
2.3. Analysis
Comparison 2 Recombinant zoster vaccine versus placebo, Outcome 3 Participants with adverse events.
2.4
2.4. Analysis
Comparison 2 Recombinant zoster vaccine versus placebo, Outcome 4 Dropouts.
See this image and copyright information in PMC

Update of

References

References to studies included in this review

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Chlibek 2013 {published data only (unpublished sought but not used)}
    1. Chlibek R, Bayas JM, Collins H, Pinta MLR, Ledent E, Johann F, et al. Safety and immunogenicity of an AS01 adjuvanted varicella‐zoster virus subunit candidate vaccine against herpes zoster in adults ≥ 50 years of age. Journal of Infectious Diseases 2013;208:1953–61. - PubMed
Chlibek 2014 {published data only (unpublished sought but not used)}
    1. Chlibek R, Smetana J, Pauksens K, Rombo L, Hoek JA, 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. - PubMed
Cunningham 2016 {published data only}
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Diez‐Domingo 2015 {published and unpublished data}
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Gilderman 2008 {published data only}
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Hata 2016 {published data only}
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Lal 2018 {published data only}
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Levin 2018 {published data only}
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Maréchal 2018 {published data only}
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Mills 2010 {published data only}
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Murray 2011 {published data only}
    1. Murray AV, Reisinger KS, Kerzner B, Stek JE, Sausser TA, Xu J, et al. Safety and tolerability of zoster vaccine in adults ≥ 60 years old. Human Vaccines 2011;7(11):1130‐6. [DOI: ] - PMC - PubMed
NCT00886613 {published data only}
    1. NCT00886613. A study to evaluate immunity to varicella zoster virus after immunization with V212 vaccine or zostavax (V212‐003) [A double‐blind, randomized, placebo controlled, parallel group study to evaluate biomarkers of immunity to varicella zoster virus following immunization with V212/heat‐treated varicella‐zoster virus (VZV) vaccine or with ZOSTAVAX in healthy volunteers]. clinicaltrials.gov/ct2/show/NCT00886613 (first received 22 April 2009).
NCT01505647 {unpublished data only}
    1. NCT01505647. Safety and immunogenicity of zoster vaccine (ZOSTAVAX™) made with an alternative manufacturing process (AMP) (V211‐042 AM1) [A phase III double‐blinded, randomized, multicenter, controlled study to evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ made with an alternative manufacturing process (AMP)]. clinicaltrials.gov/ct2/show/study/NCT01505647 (first received 4 January 2012).
NCT02052596 {published data only}
    1. NCT02052596. Immunogenicity and safety study of GSK Biologicals' herpes zoster vaccine GSK1437173A when co‐administered with Boostrix® in adults aged 50 years and older [Study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals' herpes zoster subunit (HZ/su) vaccine (GSK1437173A) when co‐administered with GSK Biologicals' diphtheria, tetanus and pertussis vaccine (Boostrix®) in adults aged 50 years and older]. clinicaltrials.gov/ct2/show/study/NCT02052596 date first submitted: 23 January 2014, date first posted: 3 February 2014.
Oxman 2005 {published data only}
    1. Levin MJ, Oxman MN, Zhang JH, Johnson GR, Stanley H, Hayward AR, et al. Varicella‐zoster virus‐specific immune responses in elderly recipients of a herpes zoster vaccine. Journal of Infectious Diseases 2008;197:825‐35. [DOI: 10.1086/528696] - DOI - PMC - PubMed
    1. Oxman MN, Levin MJ, Johnson GR, Schmader KE, Straus SE, Gelb LD, et al. A vaccine to prevent herpes zoster and postherpetic neuralgia in older adults. New England Journal of Medicine 2005;352(22):2271‐84. [PUBMED: 15930418] - PubMed
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Schwarz 2017 {published data only}
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Tyring 2007 {published data only}
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Vesikari 2013 {published data only (unpublished sought but not used)}
    1. Vesikari T, Hardt R, Rümke HC, Icardi G, Montero J, Thomas S, et al. Immunogenicity and safety of a live attenuated shingles (herpes zoster) vaccine (Zostavax®) in individuals aged ≥ 70 years. A randomized study of a single dose vs. two different two‐dose schedules. Human Vaccines and Immunotherapeutics 2013;9(4):1–7. - PMC - PubMed
Vink 2017 {published data only}
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References to studies excluded from this review

Hayward 1994 {published data only}
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Hayward 1996 {published data only}
    1. Hayward AR, Buda K, Jones M, White CJ, Levin MJ. Varicella zoster virus specific cytotoxicity following secondary immunization with live or killed vaccine. Viral Immunology 1996;9(4):241‐5. [PUBMED: 8978020] - PubMed
Irwin 2007 {published data only}
    1. Irwin MR, Olmstead R, Oxman MN. Augmenting immune responses to varicella zoster virus in older adults: a randomized, controlled trial of tai chi. Journal of the American Geriatrics Society 2007;55(4):511‐7. [DOI: 10.1111/j.532-5415.2007.01109.x] - DOI - PubMed
Kerzner 2007 {published data only}
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Kovac 2018 {published data only}
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Leroux‐Roels 2012 {published data only}
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Macaladad 2007 {published data only}
    1. Macaladad N, Marcano T, Guzman M, Moya J, Jurado F, Thompson M, et al. Safety and immunogenicity of a zoster vaccine in varicella‐zoster virus seronegative and low‐seropositive healthy adults. Vaccine 2007;25(11):2139‐44. [DOI: 10.1016/j.vaccine.2006.11.011] - DOI - PubMed
MacIntyre 2010 {published data only}
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Patterson‐Bartlett 2007 {published data only}
    1. Patterson‐Bartlett J, Levin MJ, Lang N, Schödel FP, Vessey R, Weingerg A. Phenotypic and functional characterization of ex vivo T cell responses to the live attenuated herpes zoster vaccine. Vaccine 2007;25(41):7087‐93. [PUBMED: 17766015] - PubMed
Strezova 2017 {published data only}
    1. Strezova A, Godeaux O, Aggarwal N, Leroux‐Roels G, Lopez‐Fauqued M, Damme PV, et al. A randomized lot‐to‐lot immunogenicity consistency study of the candidate zoster vaccine HZ/su. Vaccine 2017;35(48 Part B):6700‐6. [DOI: 10.1016/j.vaccine.2017.10.017] - DOI - PubMed
Weinberg 2018 {published data only}
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References to ongoing studies

NCT02180295 {published data only}
    1. NCT02180295. A lot‐to‐lot consistency study to evaluate safety, tolerability, and immunogenicity of inactivated varicella zoster virus (VZV) vaccine in healthy adults (V212‐014). clinicaltrials.gov/ct2/show/NCT02180295 (first received 2 July 2014).
NCT02526745 {published data only}
    1. NCT02526745. Safety and immunogenicity study of live attenuated vaccine against herpes zoster in Chinese adults aged 50 years and older. clinicaltrials.gov/ct2/show/NCT02526745 (first received 18 August 2015).
NCT03116594 {published data only}
    1. NCT03116594. Immunogenicity and safety of two lots of NBP608 compared to Zostavax in healthy adult aged 50 and over. clinicaltrials.gov/ct2/show/NCT03116594 (first received 17 April 2017).
NCT03120364 {published data only}
    1. NCT03120364. Immunogenicity and safety of NBP608 compared to Zostavax in healthy adult aged 50 and over. clinicaltrials.gov/ct2/show/NCT03120364 (first received 19 April 2017).
NCT03439657 {published data only}
    1. NCT03439657. Immunogenicity and safety study of GSK Biologicals' herpes zoster vaccine GSK1437173A when co‐administered with Prevnar 13 in adults aged 50 years and older. clinicaltrials.gov/ct2/show/NCT03439657 (first received 20 February 2018).

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