Document Detail

Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial.
MedLine Citation:
PMID:  16980114     Owner:  NLM     Status:  MEDLINE    
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 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.
Jiangtao Lin; Jiansan Zhang; Xiaoping Dong; Hanhua Fang; Jiangting Chen; Nan Su; Qiang Gao; Zhenshan Zhang; Yuxuan Liu; Zhihong Wang; Meng Yang; Ruihua Sun; Changgui Li; Su Lin; Mei Ji; Yan Liu; Xu Wang; John Wood; Zijian Feng; Yu Wang; Weidong Yin
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Publication Detail:
Type:  Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  368     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-09-18     Completed Date:  2006-10-06     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  991-7     Citation Subset:  AIM; IM    
Chinese-Japanese Friendship Hospital, Beijing, China.
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MeSH Terms
Adjuvants, Immunologic / administration & dosage
Aluminum Hydroxide / administration & dosage,  immunology
Dose-Response Relationship, Drug
Double-Blind Method
Hemagglutination Inhibition Tests
Hemagglutination, Viral
Influenza A Virus, H5N1 Subtype*
Influenza Vaccines / administration & dosage,  immunology*
Influenza, Human / prevention & control*
Vaccines, Inactivated
Reg. No./Substance:
0/Adjuvants, Immunologic; 0/Influenza Vaccines; 0/Vaccines, Inactivated; 21645-51-2/Aluminum Hydroxide
Comment In:
Lancet. 2006 Sep 16;368(9540):965-6   [PMID:  16980092 ]

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