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Article: A double-blind, randomized phase 2 controlled trial of intradermal hepatitis B vaccination with a topical Toll-like receptor 7 agonist imiquimod, in patients on dialysis

TitleA double-blind, randomized phase 2 controlled trial of intradermal hepatitis B vaccination with a topical Toll-like receptor 7 agonist imiquimod, in patients on dialysis
Authors
Keywordsintradermal
TLR7 agonist
hepatitis B vaccination
dialysis
Issue Date2020
PublisherOxford University Press. The Journal's web site is located at http://www.oxfordjournals.org/our_journals/cid/
Citation
Clinical Infectious Diseases, 2020, Epub 2020-06-18 How to Cite?
AbstractBackground: Patients on dialysis are hyporesponsive to the hepatitis B virus vaccines (HBVv). We examined intradermal (ID) HBVv Sci-B-Vac, with topical Toll-like receptor 7 (TLR7) agonist imiquimod pretreatment in dialysis patients. Methods: We enrolled and prospectively followed adult patients on dialysis between January 2016 and September 2018. Eligible patients were randomly allocated (1:1:1) into 1 treatment group, topical imiquimod cream followed by ID HBVv (IMQ + ID); and 2 control groups: topical aqueous cream (placebo) followed by ID HBVv (AQ + ID) or topical aqueous cream followed by intramuscular HBVv (AQ + IM). The primary endpoint was the seroprotection rate (hepatitis B surface antibody ≥10 mIU/mL) at 52 weeks. Results: Ninety-four patients were enrolled, among which 57.4% were previous nonresponders. Seroprotection rate was significantly better at week 52 for the IMQ + ID group with 96.9% compared to 74.2% and 48.4% for AQ + ID and AQ + IM groups, respectively (P < .0001). The geometric mean concentration was significantly higher at week 52 for the IMQ + ID group: 1135 (95% confidence interval [CI], 579.4–2218.2) mIU/mL, compared to 86.9 (95% CI, 18.5–409.3) mIU/mL and 7.2 (2.0–26.5) mIU/mL for the AQ + ID and AQ + IM groups, respectively (P < .0001). IMQ + ID vaccination (odds ratio, 3.70 [95% CI, 1.16–11.81]; P = .027) was the only factor independently associated with higher 52-week seroprotection rate. Adverse reaction was infrequent. Conclusions: Pretreatment with topical imiquimod before ID HBVv Sci-B-Vac was safe with favorable seroprotection in dialysis patients. Clinical Trials Registration: NCT02621112.
Persistent Identifierhttp://hdl.handle.net/10722/284580
ISSN
2019 Impact Factor: 8.313
2015 SCImago Journal Rankings: 4.742

 

DC FieldValueLanguage
dc.contributor.authorHung, IFN-
dc.contributor.authorYap, DYH-
dc.contributor.authorYip, TPS-
dc.contributor.authorZhang, RR-
dc.contributor.authorTo, KKW-
dc.contributor.authorChan, KH-
dc.contributor.authorTang, SCW-
dc.contributor.authorLui, SL-
dc.contributor.authorLevin, Y-
dc.contributor.authorKochba, E-
dc.contributor.authorLau, JYN-
dc.contributor.authorYuen, MF-
dc.contributor.authorChan, TM-
dc.contributor.authorYuen, KY-
dc.date.accessioned2020-08-07T08:59:39Z-
dc.date.available2020-08-07T08:59:39Z-
dc.date.issued2020-
dc.identifier.citationClinical Infectious Diseases, 2020, Epub 2020-06-18-
dc.identifier.issn1058-4838-
dc.identifier.urihttp://hdl.handle.net/10722/284580-
dc.description.abstractBackground: Patients on dialysis are hyporesponsive to the hepatitis B virus vaccines (HBVv). We examined intradermal (ID) HBVv Sci-B-Vac, with topical Toll-like receptor 7 (TLR7) agonist imiquimod pretreatment in dialysis patients. Methods: We enrolled and prospectively followed adult patients on dialysis between January 2016 and September 2018. Eligible patients were randomly allocated (1:1:1) into 1 treatment group, topical imiquimod cream followed by ID HBVv (IMQ + ID); and 2 control groups: topical aqueous cream (placebo) followed by ID HBVv (AQ + ID) or topical aqueous cream followed by intramuscular HBVv (AQ + IM). The primary endpoint was the seroprotection rate (hepatitis B surface antibody ≥10 mIU/mL) at 52 weeks. Results: Ninety-four patients were enrolled, among which 57.4% were previous nonresponders. Seroprotection rate was significantly better at week 52 for the IMQ + ID group with 96.9% compared to 74.2% and 48.4% for AQ + ID and AQ + IM groups, respectively (P < .0001). The geometric mean concentration was significantly higher at week 52 for the IMQ + ID group: 1135 (95% confidence interval [CI], 579.4–2218.2) mIU/mL, compared to 86.9 (95% CI, 18.5–409.3) mIU/mL and 7.2 (2.0–26.5) mIU/mL for the AQ + ID and AQ + IM groups, respectively (P < .0001). IMQ + ID vaccination (odds ratio, 3.70 [95% CI, 1.16–11.81]; P = .027) was the only factor independently associated with higher 52-week seroprotection rate. Adverse reaction was infrequent. Conclusions: Pretreatment with topical imiquimod before ID HBVv Sci-B-Vac was safe with favorable seroprotection in dialysis patients. Clinical Trials Registration: NCT02621112.-
dc.languageeng-
dc.publisherOxford University Press. The Journal's web site is located at http://www.oxfordjournals.org/our_journals/cid/-
dc.relation.ispartofClinical Infectious Diseases-
dc.rightsPre-print: Journal Title] ©: [year] [owner as specified on the article] Published by Oxford University Press [on behalf of xxxxxx]. All rights reserved. Pre-print (Once an article is published, preprint notice should be amended to): This is an electronic version of an article published in [include the complete citation information for the final version of the Article as published in the print edition of the Journal.] Post-print: This is a pre-copy-editing, author-produced PDF of an article accepted for publication in [insert journal title] following peer review. The definitive publisher-authenticated version [insert complete citation information here] is available online at: xxxxxxx [insert URL that the author will receive upon publication here].-
dc.subjectintradermal-
dc.subjectTLR7 agonist-
dc.subjecthepatitis B vaccination-
dc.subjectdialysis-
dc.titleA double-blind, randomized phase 2 controlled trial of intradermal hepatitis B vaccination with a topical Toll-like receptor 7 agonist imiquimod, in patients on dialysis-
dc.typeArticle-
dc.identifier.emailHung, IFN: ivanhung@hkucc.hku.hk-
dc.identifier.emailYap, DYH: desmondy@hku.hk-
dc.identifier.emailYip, TPS: tpsyip@hku.hk-
dc.identifier.emailZhang, RR: zhangrq@hku.hk-
dc.identifier.emailTo, KKW: kelvinto@hku.hk-
dc.identifier.emailChan, KH: chankh2@hkucc.hku.hk-
dc.identifier.emailTang, SCW: scwtang@hku.hk-
dc.identifier.emailLui, SL: sllui@hkucc.hku.hk-
dc.identifier.emailYuen, MF: mfyuen@hku.hk-
dc.identifier.emailChan, TM: dtmchan@hkucc.hku.hk-
dc.identifier.emailYuen, KY: kyyuen@hkucc.hku.hk-
dc.identifier.authorityHung, IFN=rp00508-
dc.identifier.authorityYap, DYH=rp01607-
dc.identifier.authorityTo, KKW=rp01384-
dc.identifier.authorityChan, KH=rp01921-
dc.identifier.authorityTang, SCW=rp00480-
dc.identifier.authorityYuen, MF=rp00479-
dc.identifier.authorityChan, TM=rp00394-
dc.identifier.authorityYuen, KY=rp00366-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1093/cid/ciaa804-
dc.identifier.pmid32556176-
dc.identifier.hkuros312447-
dc.identifier.volumeEpub 2020-06-18-
dc.identifier.spageciaa804-
dc.identifier.epageciaa804-
dc.publisher.placeUnited States-

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