1: 中日友好医院与北京科兴公司合作刚刚发表，通讯作者尹卫东。
Lancet. 2006 Sep 16;368(9540):991-7.
Comment in:
Lancet. 2006 Sep 16;368(9540):965-6.
Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A
(H5N1) vaccine: a phase I randomised controlled trial.
Lin J, Zhang J, Dong X, Fang H, Chen J, Su N, Gao Q, Zhang Z, Liu Y, Wang Z,
Yang M, Sun R, Li C, Lin S, Ji M, Liu Y, Wang X, Wood J, Feng Z, Wang Y, Yin W.
Chinese-Japanese Friendship Hospital, Beijing, China.
BACKGROUND: Avian influenza A virus H5N1 has caused widespread infections that
have resulted in severe disease or death in poultry and wild birds as well as
human beings. This virus has the potential to emerge as a pandemic threat and
H5N1 vaccines are being developed in many countries. Our aim was to assess the
safety and immunogenicity of an inactivated adjuvanted whole-virion H5N1
vaccine. METHODS: A stratified randomised, placebo-controlled, double-blind
phase I clinical trial was done in 120 volunteers aged 18-60 years. Volunteers
were assigned to receive two doses of placebo (n=24) or an inactivated
whole-virion influenza A (H5N1) vaccine with 1.25 microg (24), 2.5 microg (24),
5 microg (24), or 10 microg (24) haemagglutinin per dose with aluminium
hydroxide adjuvant on day 0 and 28. Serum samples were obtained on day 0, 14,
28, 42, and 56 for haemagglutination inhibition and virus neutralisation assays.
This trial is registered with the ClinicalTrials.gov registry with the number
NCT00356798. FINDINGS: All four formulations of vaccines were well tolerated. No
serious adverse event was reported and most local and systemic reactions were
mild and transient. All formulations induced antibody responses after the first
dose; the highest immune response of 78% seropositivity was seen in the 10 mug
group after two vaccine doses. Two individuals dropped out: one in the 1.25
microg group (withdrew consent) and one in the 10 microg group (discontinued);
one individual was also excluded from the final analysis. INTERPRETATION: A
two-dose regimen of an adjuvanted 10 microg inactivated whole-virion H5N1
vaccine met all European regulatory requirements for annual licensing of
seasonal influenza vaccine. Lower doses of this vaccine could achieve immune
responses equivalent to those elicited by adjuvanted or non-adjuvanted
split-virion vaccines. The use of a whole virion vaccine could be more adaptable
to the antigen-sparing strategy recommended by WHO for protection against an
influenza pandemic.
Publication Types:
Clinical Trial, Phase I
Randomized Controlled Trial
2: 北京CDC杨维中教授
Lancet. 2006 Feb 4;367(9508):419-23.
Identification of a new Neisseria meningitidis serogroup C clone from Anhui
province, China.
Shao Z, Li W, Ren J, Liang X, Xu L, Diao B, Li M, Lu M, Ren H, Cui Z, Zhu B, Dai
Z, Zhang L, Chen X, Kan B, Xu J.
National Institute for Communicable Disease Control and Prevention, Chinese
Center for Disease Control and Prevention (China CDC), PO Box 5, Changping,
Beijing 102206, China.
BACKGROUND: Outbreaks of a new serogroup C meningococcal disease emerged during
2003-04 (five outbreaks with 43 cases) and in 2004-05 (five outbreaks with 29
cases), all in Anhui province, China. We describe the molecular epidemiology and
features of the causative bacterial strains. METHODS: We used pulsed-field gel
electrophoresis (PFGE) and multi-locus sequence typing (MLST) to analyse the
strains. FINDINGS: Of 34 strains of Neisseria meningitidis cultured during
2003-04 from Anhui province, 31 were group C meningococci, 28 of which were
associated with three of five outbreaks; one from a patient and 27 from close
contacts of eight patients. Of 30 strains isolated from Anhui province during
2004-05, 17 were identified as serogroup C meningococci, ten of which were
associated with four of five outbreaks. In a nationwide survey, 542 strains were
isolated during 2004-05; 58 were serogroup C meningococci interspersed among 11
other provinces where no serogroup C outbreak occurred. Of the 106 serogroup C
strains analysed, 89 had identical PFGE patterns, designated AH1. Of 28 strains
selected for MLST analyses, 25 were sequence type 4821 (ST-4821), which did not
belong to any of the previously reported sequence types that can form a new
hypervirulent lineage. INTERPRETATION: ST-4821 seems to be unique and caused the
serogroup C meningitis outbreaks during the two seasons from 2003 to 2005 in
Anhui province. The emergence of this sequence type has epidemiological
importance that should be monitored for future spread in China and the rest of
the world.
3: 北京CDC徐建国教授。
Lancet. 2006 Jan 7;367(9504):84.
The first confirmed human case of avian influenza A (H5N1) in Mainland China.
Yu H, Shu Y, Hu S, Zhang H, Gao Z, Chen H, Dong J, Xu C, Zhang Y, Xiang N, Wang
M, Guo Y, Cox N, Lim W, Li D, Wang Y, Yang W.
Office for Disease Control and Emergency Response, Chinese Center for Disease
Control and Prevention (China CDC), 27 Nanwei Road, Beijing, 100050, PR China.
Publication Types:
Case Reports
