絞り込み

16644

広告

原発廃炉の在り方は? シンポジウムで高校生などが議論 福島 (NHK)

福島第一原子力発電所の事故からまもなく9年となるのを前に、廃炉をテーマにしたシンポジウムが福島県で開かれました。 福島第一原発の廃炉について、国や東京電力は30...

  1. 中国「感染力は強まっている」 武漢からの...
  2. 高額な製薬マネーは「正当な対価」? 中立...
  3. 雪がないなか「氷室の仕込み」 金沢 (N...
  4. 副業に励む医学部教授 国公立の15人に製...

ニュース一覧

Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study.

著者 Santolaya ME , O'Ryan ML , Valenzuela MT , Prado V , Vergara R , Muñoz A , Toneatto D , Graña G , Wang H , Clemens R , Dull PM ,
Lancet.2012 Jan 17 ; ():.
この記事をPubMed上で見るPubMedで表示
この記事をGoogle翻訳上で見る Google翻訳で開く

Departamento de Pediatría, Hospital Dr Luis Calvo Mackenna, Facultad de Medicina, Universidad de Chile, Santiago, Chile.

スターを付ける スターを付ける     (28view , 0users)

Full Text Sources

Medical

Other Literature Sources

BACKGROUND: Effective glycoconjugate vaccines against Neisseria meningitidis serogroups A, C, W-135, and Y have been developed, but serogroup B remains a major cause of severe invasive disease in infants and adolescents worldwide. We assessed immunogenicity and tolerability of a four-component vaccine (4CMenB) in adolescents. METHODS: We did a randomised, observer-blind, placebo-controlled, study at 12 sites in Santiago and Valparaíso, Chile. Adolescents aged 11-17 years received one, two, or three doses of 4CMenB at 1 month, 2 month, or 6 month intervals. Immunogenicity was assessed as serum bactericidal activity using human complement (hSBA) against three reference strains for individual vaccine antigens, and assessed by ELISA against the fourth strain. Local and systemic reactions were recorded 7 days after each vaccination, and adverse events were monitored throughout the study. Participants were initially randomised to five groups (3:3:3:3:1) during the primary phase to receive either one dose, two doses 1 or 2 months apart, or three doses of 4CMenB, or three doses of placebo, with an additional three groups generated for the booster phase. All subjects received at least one dose of 4CMenB. Geometric mean titres, proportions of participants with serum bactericidal antibody titres of 4 or more, and Clopper-Pearson 95% CIs were calculated. The study is registered with ClinicalTrials.gov, number NCT00661713. FINDINGS: Overall, 1631 adolescents (mean age 13·8 [SD 1·9] years) received at least one dose of 4CMenB. After two or three doses, 99-100% of recipients had hSBA titres of 4 or more against test strains, compared with 92-97% after one dose (p<0·0145) and 29-50% after placebo. At 6 months 91-100% of participants still had titres of 4 or more for each strain after two or three doses, but only 73-76% after one dose; seroresponse rates reached 99-100% for each strain after second or third doses at 6 months. Local and systemic reaction rates were similar after each 4CMenB injection and did not increase with subsequent doses, but remained higher than placebo. No vaccine-related serious adverse events were reported and no significant safety signals were identified. INTERPRETATION: On the basis of immunogenicity responses this study provides evidence for an adolescent 4CMenB vaccine schedule of two doses, 1-6 months apart, to provide protection against meningococcal B infection. The extent of this protection against meningococcus B variants circulating worldwide will be determined by national surveys. FUNDING: Novartis Vaccines and Diagnostics.
PMID: 22260988 [PubMed - as supplied by publisher]
印刷用ページを開く Endnote用テキストダウンロード