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Meta-Analysis
. 2016 Mar 3;3(3):CD008858.
doi: 10.1002/14651858.CD008858.pub3.

Vaccines for preventing herpes zoster in older adults

Anna M Z Gagliardi  1 , Brenda N G Andriolo, Maria R Torloni, Bernardo G O Soares
Affiliations
Meta-Analysis

Vaccines for preventing herpes zoster in older adults

Anna M Z Gagliardi et al. Cochrane Database Syst Rev. .

Update in

Abstract

Background: Herpes zoster, also known as 'shingles', is a neurocutaneous disease characterised by the reactivation of the latent varicella zoster virus (VZV), the virus that causes chickenpox when immunity to VZV declines. It is an extremely painful condition that can last many weeks or months and it can significantly compromise the quality of life of affected individuals. 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 VZV activates specific T cell production avoiding viral reactivation. The Food and Drug Administration has approved a herpes zoster vaccine with an attenuated active virus for clinical use among older adults, which has been tested in large populations. A new adjuvanted recombinant VZV subunit zoster vaccine has also been tested. It consists of recombinant VZV glycoprotein E and a liposome-based AS01B adjuvant system. This new vaccine is not yet available for clinical use.

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

Search methods: For this 2015 update, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2015, Issue 9), MEDLINE (1948 to the 3rd week of October 2015), EMBASE (2010 to October 2015), CINAHL (1981 to October 2015) and LILACS (1982 to October 2015).

Selection criteria: Randomised controlled trials (RCTs) or quasi-RCTs comparing zoster vaccine with placebo or no vaccine, to prevent herpes zoster in older adults (mean age > 60 years).

Data collection and analysis: Two review authors independently collected and analysed data using a data extraction form. They also performed 'Risk of bias' assessment.

Main results: We identified 13 studies involving 69,916 participants. The largest study included 38,546 participants. All studies were conducted in high-income countries and included only healthy Caucasian individuals ≥ 60 years of age without immunosuppressive comorbidities. Ten studies used live attenuated varicella zoster virus (VZV) vaccines. Three studies tested a new type of vaccine not yet available for clinical use. We judged five of the included studies to be at low risk of bias.The incidence of herpes zoster, at up to three years of follow-up, was lower in participants who received the vaccine than in those who received a placebo: risk ratio (RR) 0.49; 95% confidence interval (CI) 0.43 to 0.56, risk difference (RD) 2%, number needed to treat to benefit (NNTB) 50; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of mild to moderate intensity adverse events. These date came from one large study that included 38,546 people aged 60 years or older.A study including 8122 participants compared the new vaccine (not yet available) to the placebo; the group that received the new vaccine had a lower incidence of herpes zoster at 3.2 years of follow-up: RR 0.04, 95% CI 0.02 to 0.10, RD 3%, NNTB 33; GRADE: moderate quality evidence. The vaccinated group had a higher incidence of adverse events but most them were of mild to moderate intensity.All studies received funding from the pharmaceutical industry.

Authors' conclusions: Herpes zoster vaccine is effective in preventing herpes zoster disease and this protection can last three years. In general, zoster vaccine is well tolerated; it produces few systemic adverse events and injection site adverse events of mild to moderate intensity.There are studies of a new vaccine (with a VZV glycoproteic fraction plus adjuvant), which is currently not yet available for clinical use.

PubMed Disclaimer

Conflict of interest statement

Anna MZ Gagliardi: none known Brenda NG Andriolo: none known Maria R Torloni: none known Bernardo GO Soares: none known

Figures

Figure 1
Figure 1
Study flow diagram 2015 update
Figure 2
Figure 2
'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figure 3
Figure 3
'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
Analysis 1.1
Analysis 1.1
Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 1 Incidence of herpes zoster.
Analysis 1.2
Analysis 1.2
Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 2 Incidence of herpes zoster with ZBPI ADL. Severity of interference scores of 300 or greater (high score is worse).
Analysis 1.3
Analysis 1.3
Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 3 Participants with AEs.
Analysis 1.4
Analysis 1.4
Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 4 Drop‐outs.
Analysis 1.5
Analysis 1.5
Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 5 Participants with no follow‐up.
Analysis 2.1
Analysis 2.1
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 1 Incidence of herpes zoster.
Analysis 2.2
Analysis 2.2
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 2 Vaccine‐related adverse effects.
Analysis 2.3
Analysis 2.3
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 3 Vaccine‐related systemic adverse effects.
Analysis 2.4
Analysis 2.4
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 4 Vaccine‐related serious adverse effects.
Analysis 2.5
Analysis 2.5
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 5 Injection site vaccine‐related adverse effects.
Analysis 2.6
Analysis 2.6
Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 6 Participants with no follow‐up.
Analysis 3.1
Analysis 3.1
Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 1 Participants with adverse effects.
Analysis 3.2
Analysis 3.2
Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 2 Participants with no follow‐up.
Analysis 4.1
Analysis 4.1
Comparison 4 Live attenuated VZV zoster vaccine versus inactivated zoster vaccine, Outcome 1 Incidence of herpes zoster.
Analysis 5.1
Analysis 5.1
Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 1 3200 pfu VZV/dose.
Analysis 5.2
Analysis 5.2
Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 2 8500 pfu VZV/dose.
Analysis 5.3
Analysis 5.3
Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 3 41,650 pfu/dose.
Analysis 5.4
Analysis 5.4
Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 4 Duration in days of adverse effects.
Analysis 6.1
Analysis 6.1
Comparison 6 Live attenuated VZV zoster vaccine IM route versus zoster vaccine SC route, Outcome 1 Participants with adverse events.
Analysis 7.1
Analysis 7.1
Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 1 Zoster vaccine 1 month schedule versus zoster vaccine 3 month schedule.
Analysis 7.2
Analysis 7.2
Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 2 Zoster vaccine 1 month schedule versus zoster vaccine single dose.
Analysis 7.3
Analysis 7.3
Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 3 Zoster vaccine 3 month schedule versus zoster vaccine single dose.
Analysis 8.1
Analysis 8.1
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 1 50 μg gE/AS01E versus 50 μg gE/AS01B.
Analysis 8.2
Analysis 8.2
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 2 50 μg gE/AS01E versus 50 μg gE/saline (unadjuvanted gE).
Analysis 8.3
Analysis 8.3
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 3 50 μg gE/AS01B versus 50 μg gE/saline (unadjuvanted gE).
Analysis 8.4
Analysis 8.4
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 4 50 μg gE/AS01E versus saline.
Analysis 8.5
Analysis 8.5
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 5 50 μg gE/AS01B versus saline.
Analysis 8.6
Analysis 8.6
Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 6 50 μg gE/Saline (unadjuvanted) versus saline.
Analysis 9.1
Analysis 9.1
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 1 25 µg gE/AS01B versus 50 µg gE/AS01B.
Analysis 9.2
Analysis 9.2
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 2 25 µg gE/AS01B versus 100 µg gE/AS01B.
Analysis 9.3
Analysis 9.3
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 3 50 µg gE/AS01B versus 100 µg gE/AS01B.
Analysis 9.4
Analysis 9.4
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 4 25 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
Analysis 9.5
Analysis 9.5
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 5 50 µg gE/AS01B a versus 100 µg gE/saline (unadjuvanted gE).
Analysis 9.6
Analysis 9.6
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 6 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
Analysis 9.7
Analysis 9.7
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 7 25 µg gE/AS01B versus saline + 100 µg gE/AS01B.
Analysis 9.8
Analysis 9.8
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 8 50 µg gE/AS01B versus saline + 100 µg gE/AS01B.
Analysis 9.9
Analysis 9.9
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 9 100 µg gE/AS01B versus saline + 100 µg gE/AS01B.
Analysis 9.10
Analysis 9.10
Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 10 Saline + 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
Analysis 10.1
Analysis 10.1
Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 1 Incidence of herpes zoster 3.2 years follow‐up (≥ 60 yo).
Analysis 10.2
Analysis 10.2
Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 2 Participants with AEs.
Analysis 10.3
Analysis 10.3
Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 3 Drop‐outs.
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Update of

References

References to studies included in this review

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References to ongoing studies

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    1. 'A phase III double‐blinded, randomised, multicenter, controlled study to evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ made with an alternative manufacturing process (AMP)'. Ongoing studyApril 2012.

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References to other published versions of this review

    1. Gagliardi AMZ, Gomes SBN, Torloni MR, Soares BGO. Vaccines for preventing herpes zoster in older adults. Cochrane Database of Systematic Reviews 2010, Issue 12. [DOI: 10.1002/14651858.CD008858] - DOI - PubMed
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