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Article: Safety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial

TitleSafety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial
Authors
Keywordsherpes zoster
immunogenicity
live-attenuated
lupus
safety
Issue Date2019
PublisherBMJ Publishing Group. The Journal's web site is located at http://ard.bmjjournals.com/
Citation
Annals of the Rheumatic Diseases, 2019, v. 78, p. 1663-1668 How to Cite?
AbstractObjectives: To study the safety and immunogenicity of a live-attenuated herpes zoster (HZ) vaccine in patients with systemic lupus erythematosus (SLE). Methods: Adult SLE patients having a SLEDAI <6 and stable immunosuppressive treatment for ≥6 months were recruited. Participants were randomly assigned to receive HZ vaccine (Zostavax) or placebo injection. Anti-varicella zoster virus (VZV) IgG reactivity (baseline and week 6) was measured by an enzyme-linked fluorescence assay. Cell-mediated response was assessed by a VZV-stimulated interferon-gamma (IFN-γ) enzyme-linked ELISPOT assay. Adverse events and immune responses of the two groups were compared. Results: 90 SLE patients were recruited (age 45.6±14.1 years; 93% women) and assigned to Zostavax or placebo (in 1:1 ratio). Baseline clinical parameters were similar between the two groups. The change in anti-VZV IgG from week 0 to 6 was +59.8% in the vaccine and −2.1% in the placebo group. Week 6 anti-VZV IgG was significantly higher in vaccinated than placebo-treated patients, after adjustment for baseline (4.16±1.26 vs 3.32±1.01; p<0.001). The number of IFN-γ secreting T-cell spots decreased in the placebo-treated patients (−17%) but increased in vaccinated patients (+42%). The T-cell spots number at week 6 was significantly higher in vaccine—than placebo-treated patients after adjustment for baseline (38.1±78.2 vs 23.1±47.9; p=0.02). Significantly more vaccinated patients reported self-limiting injection site reaction than controls (31% vs 7%; p<0.01). Two vaccinated patients (4.4%) and one (2.2%) placebo-treated patient had mild/moderate SLE flares but no patients developed HZ eruption within 6 weeks postvaccination. Conclusions: In patients with stable SLE not receiving intensive immunosuppression, Zostavax was well-tolerated and provoked an immune response. Trial registration number US ClinicalTrials.gov registry (NCT02477150).
Persistent Identifierhttp://hdl.handle.net/10722/281890
ISSN
2019 Impact Factor: 16.102
2015 SCImago Journal Rankings: 4.537

 

DC FieldValueLanguage
dc.contributor.authorMok, CC-
dc.contributor.authorChan, KH-
dc.contributor.authorHo, LY-
dc.contributor.authorFung, YF-
dc.contributor.authorFung, WF-
dc.contributor.authorWoo, PCY-
dc.date.accessioned2020-04-03T07:23:13Z-
dc.date.available2020-04-03T07:23:13Z-
dc.date.issued2019-
dc.identifier.citationAnnals of the Rheumatic Diseases, 2019, v. 78, p. 1663-1668-
dc.identifier.issn0003-4967-
dc.identifier.urihttp://hdl.handle.net/10722/281890-
dc.description.abstractObjectives: To study the safety and immunogenicity of a live-attenuated herpes zoster (HZ) vaccine in patients with systemic lupus erythematosus (SLE). Methods: Adult SLE patients having a SLEDAI <6 and stable immunosuppressive treatment for ≥6 months were recruited. Participants were randomly assigned to receive HZ vaccine (Zostavax) or placebo injection. Anti-varicella zoster virus (VZV) IgG reactivity (baseline and week 6) was measured by an enzyme-linked fluorescence assay. Cell-mediated response was assessed by a VZV-stimulated interferon-gamma (IFN-γ) enzyme-linked ELISPOT assay. Adverse events and immune responses of the two groups were compared. Results: 90 SLE patients were recruited (age 45.6±14.1 years; 93% women) and assigned to Zostavax or placebo (in 1:1 ratio). Baseline clinical parameters were similar between the two groups. The change in anti-VZV IgG from week 0 to 6 was +59.8% in the vaccine and −2.1% in the placebo group. Week 6 anti-VZV IgG was significantly higher in vaccinated than placebo-treated patients, after adjustment for baseline (4.16±1.26 vs 3.32±1.01; p<0.001). The number of IFN-γ secreting T-cell spots decreased in the placebo-treated patients (−17%) but increased in vaccinated patients (+42%). The T-cell spots number at week 6 was significantly higher in vaccine—than placebo-treated patients after adjustment for baseline (38.1±78.2 vs 23.1±47.9; p=0.02). Significantly more vaccinated patients reported self-limiting injection site reaction than controls (31% vs 7%; p<0.01). Two vaccinated patients (4.4%) and one (2.2%) placebo-treated patient had mild/moderate SLE flares but no patients developed HZ eruption within 6 weeks postvaccination. Conclusions: In patients with stable SLE not receiving intensive immunosuppression, Zostavax was well-tolerated and provoked an immune response. Trial registration number US ClinicalTrials.gov registry (NCT02477150).-
dc.languageeng-
dc.publisherBMJ Publishing Group. The Journal's web site is located at http://ard.bmjjournals.com/-
dc.relation.ispartofAnnals of the Rheumatic Diseases-
dc.rightsAnnals of the Rheumatic Diseases. Copyright © BMJ Publishing Group.-
dc.rightsThis article has been accepted for publication in [Journal, Year] following peer review, and the Version of Record can be accessed online at [insert full DOI eg. http://dx.doi.org/10.1136/xxxxx]. [© Authors (or their employer(s)) OR © BMJ Publishing Group Ltd ( for assignments of BMJ Case Reports)] <year>-
dc.subjectherpes zoster-
dc.subjectimmunogenicity-
dc.subjectlive-attenuated-
dc.subjectlupus-
dc.subjectsafety-
dc.titleSafety and immune response of a live-attenuated herpes zoster vaccine in patients with systemic lupus erythematosus: a randomised placebo-controlled trial-
dc.typeArticle-
dc.identifier.emailChan, KH: chankh2@hkucc.hku.hk-
dc.identifier.emailFung, YF: agnes_fung@hku.hk-
dc.identifier.emailWoo, PCY: pcywoo@hkucc.hku.hk-
dc.identifier.authorityChan, KH=rp01921-
dc.identifier.authorityWoo, PCY=rp00430-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1136/annrheumdis-2019-215925-
dc.identifier.pmid31530556-
dc.identifier.scopuseid_2-s2.0-85072379833-
dc.identifier.hkuros309644-
dc.identifier.volume78-
dc.identifier.spage1663-
dc.identifier.epage1668-
dc.publisher.placeUnited Kingdom-

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