Safety and immunogenicity of an inactivated adjuvanted whole-virion influenza A (H5N1) vaccine: a phase I randomised controlled trial
| Autor: | Jiansan Zhang, Su Lin, Jiang-Tao Lin, Yu Wang, Yan Liu, Rui-Hua Sun, Xiao-Ping Dong, John Wood, Han-Hua Fang, Qiang Gao, Nan Su, Zhihong Wang, Weidong Yin, Zijian Feng, Jiang-Ting Chen, Zhenshan Zhang, Xu Wang, Meng Yang, Changgui Li, Yuxuan Liu, Mei Ji |
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| Rok vydání: | 2006 |
| Předmět: |
Adult
Male H5N1 vaccine medicine.medical_treatment Aluminum Hydroxide medicine.disease_cause Avian Influenza A Virus Adjuvants Immunologic Double-Blind Method Influenza Human Influenza A virus Humans Medicine Adverse effect Hemagglutination Viral Dose-Response Relationship Drug Influenza A Virus H5N1 Subtype business.industry Immunogenicity General Medicine Hemagglutination Inhibition Tests Virology Influenza A virus subtype H5N1 Vaccination Vaccines Inactivated Influenza Vaccines Immunology Female business Adjuvant |
| Zdroj: | The Lancet. 368:991-997 |
| ISSN: | 0140-6736 |
| DOI: | 10.1016/s0140-6736(06)69294-5 |
| Popis: | Summary 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 μg (24), 2·5 μg (24), 5 μg (24), or 10 μg (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 μg group after two vaccine doses. Two individuals dropped out: one in the 1·25 μg group (withdrew consent) and one in the 10 μg group (discontinued); one individual was also excluded from the final analysis. Interpretation A two-dose regimen of an adjuvanted 10 μg 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. |
| Databáze: | OpenAIRE |
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