File Download
  Links for fulltext
     (May Require Subscription)
Supplementary

Article: Human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in healthy Chinese women from Hong Kong

TitleHuman papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in healthy Chinese women from Hong Kong
Authors
KeywordsAdjuvants
Cervical intraepithelial neoplasia
Human papillomavirus 16
Human papillomavirus 18
Immunologic
Uterine cervical neoplasms
Issue Date2010
PublisherHong Kong Medical Association. The Journal's web site is located at http://www.hkmj.org/resources/supp.html
Citation
Hong Kong Medical Journal, 2010, v. 16 n. 3, p. 171-179 How to Cite?
AbstractObjective To assess the immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in Chinese women aged 18 to 35 years enrolled from Hong Kong. Design Double-blind, randomised controlled trial with vaccine and placebo groups. Setting Single-centre study in Hong Kong. Participants Three hundred women enrolled (150 per group) between March 2006 and June 2007. Interventions Subjects received three doses of human papillomavirus-16/18 vaccine or placebo (aluminium hydroxide), administered intramuscularly at 0, 1, and 6 months. Main outcome measures Human papillomavirus-16/18 seroconversion rates and geometric mean titres at month 7 (in human papillomavirus-16/18 recipients); reactogenicity and safety (in all subjects). Results A total of 294 women completed the study (148 in the vaccine group, 146 in placebo group). All initially seronegative subjects in the vaccine group had seroconverted for human papillomavirus-16/18 antibodies by month 7. Anti-human papillomavirus-16 and anti-human papillomavirus-18 antibody geometric mean titres were 10 422 (95% confidence interval, 8730-12 442) EL.U/mL and 4649 (3975-5437) EL.U/mL, respectively. High compliance (99% in both groups) was observed for the three-vaccination course. The frequencies of local injection site reactions were higher in the vaccine than placebo group; pain being the most common symptom in both groups. Regarding solicited symptoms, fatigue and myalgia were the most frequent in both groups. Five serious adverse events (four in vaccine group, one in placebo group) were reported, but all were considered unrelated to the vaccinations. Conclusion The human papillomavirus-16/18 AS04-adjuvanted vaccine was highly immunogenic, safe, and generally well tolerated in Chinese women from Hong Kong.
Persistent Identifierhttp://hdl.handle.net/10722/65458
ISSN
2015 Impact Factor: 0.887
2015 SCImago Journal Rankings: 0.279
References

 

DC FieldValueLanguage
dc.contributor.authorNgan, HYSen_HK
dc.contributor.authorCheung, ANYen_HK
dc.contributor.authorTam, KFen_HK
dc.contributor.authorChan, KKLen_HK
dc.contributor.authorTang, HWen_HK
dc.contributor.authorBi, Den_HK
dc.contributor.authorDescamps, Den_HK
dc.contributor.authorBock, HLen_HK
dc.date.accessioned2010-08-09T06:48:53Z-
dc.date.available2010-08-09T06:48:53Z-
dc.date.issued2010en_HK
dc.identifier.citationHong Kong Medical Journal, 2010, v. 16 n. 3, p. 171-179en_HK
dc.identifier.issn1024-2708en_HK
dc.identifier.urihttp://hdl.handle.net/10722/65458-
dc.description.abstractObjective To assess the immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine in Chinese women aged 18 to 35 years enrolled from Hong Kong. Design Double-blind, randomised controlled trial with vaccine and placebo groups. Setting Single-centre study in Hong Kong. Participants Three hundred women enrolled (150 per group) between March 2006 and June 2007. Interventions Subjects received three doses of human papillomavirus-16/18 vaccine or placebo (aluminium hydroxide), administered intramuscularly at 0, 1, and 6 months. Main outcome measures Human papillomavirus-16/18 seroconversion rates and geometric mean titres at month 7 (in human papillomavirus-16/18 recipients); reactogenicity and safety (in all subjects). Results A total of 294 women completed the study (148 in the vaccine group, 146 in placebo group). All initially seronegative subjects in the vaccine group had seroconverted for human papillomavirus-16/18 antibodies by month 7. Anti-human papillomavirus-16 and anti-human papillomavirus-18 antibody geometric mean titres were 10 422 (95% confidence interval, 8730-12 442) EL.U/mL and 4649 (3975-5437) EL.U/mL, respectively. High compliance (99% in both groups) was observed for the three-vaccination course. The frequencies of local injection site reactions were higher in the vaccine than placebo group; pain being the most common symptom in both groups. Regarding solicited symptoms, fatigue and myalgia were the most frequent in both groups. Five serious adverse events (four in vaccine group, one in placebo group) were reported, but all were considered unrelated to the vaccinations. Conclusion The human papillomavirus-16/18 AS04-adjuvanted vaccine was highly immunogenic, safe, and generally well tolerated in Chinese women from Hong Kong.en_HK
dc.languageeng-
dc.publisherHong Kong Medical Association. The Journal's web site is located at http://www.hkmj.org/resources/supp.htmlen_HK
dc.relation.ispartofHong Kong Medical Journalen_HK
dc.rightsHong Kong Medical Journal. Copyright © Hong Kong Medical Association.-
dc.rightsCreative Commons: Attribution 3.0 Hong Kong License-
dc.subjectAdjuvantsen_HK
dc.subjectCervical intraepithelial neoplasiaen_HK
dc.subjectHuman papillomavirus 16en_HK
dc.subjectHuman papillomavirus 18en_HK
dc.subjectImmunologicen_HK
dc.subjectUterine cervical neoplasmsen_HK
dc.titleHuman papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine: Immunogenicity and safety in healthy Chinese women from Hong Kongen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=1024-2708&volume=16&issue=3&spage=171&epage=179&date=2010&atitle=Human+papillomavirus-16/18+AS04-adjuvanted+cervical+cancer+vaccine:+immunogenicity+and+safety+in+healthy+Chinese+women+from+Hong+Kong-
dc.identifier.emailNgan, HYS:hysngan@hkucc.hku.hken_HK
dc.identifier.emailCheung, ANY:anycheun@hkucc.hku.hken_HK
dc.identifier.emailChan, KKL:kklchan@hkucc.hku.hken_HK
dc.identifier.authorityNgan, HYS=rp00346en_HK
dc.identifier.authorityCheung, ANY=rp00542en_HK
dc.identifier.authorityChan, KKL=rp00499en_HK
dc.description.naturepublished_or_final_version-
dc.identifier.pmid20519752-
dc.identifier.scopuseid_2-s2.0-77955787941en_HK
dc.identifier.hkuros170837-
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-77955787941&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume16en_HK
dc.identifier.issue3en_HK
dc.identifier.spage171en_HK
dc.identifier.epage179en_HK
dc.publisher.placeHong Kongen_HK
dc.identifier.scopusauthoridNgan, HYS=34571944100en_HK
dc.identifier.scopusauthoridCheung, ANY=54927484100en_HK
dc.identifier.scopusauthoridTam, KF=7201692816en_HK
dc.identifier.scopusauthoridChan, KKL=8655666700en_HK
dc.identifier.scopusauthoridTang, HW=15828580700en_HK
dc.identifier.scopusauthoridBi, D=35775202100en_HK
dc.identifier.scopusauthoridDescamps, D=16311641500en_HK
dc.identifier.scopusauthoridBock, HL=7201825902en_HK

Export via OAI-PMH Interface in XML Formats


OR


Export to Other Non-XML Formats