safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza ah5n1 vaccine in children安全、体液和细胞介导免疫反应两个配方的灭活,split-virion流感ah5n1儿童疫苗.pdfVIP

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2017-09-09 发布于上海
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safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza ah5n1 vaccine in children安全、体液和细胞介导免疫反应两个配方的灭活,split-virion流感ah5n1儿童疫苗.pdf

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safety, humoral and cell mediated immune responses to two formulations of an inactivated, split-virion influenza ah5n1 vaccine in children安全、体液和细胞介导免疫反应两个配方的灭活,split-virion流感ah5n1儿童疫苗

Safety, Humoral and Cell Mediated Immune Responses to Two Formulations of an Inactivated, Split-Virion Influenza A/H5N1 Vaccine in Children 1 2 2 3 Tawee Chotpitayasunondh , Usa Thisyakorn , Chitsanu Pancharoen , Stephanie Pepin *, Nolwenn Nougarede3 1 Queen Sirikit National Institute of Child Health, Bangkok, Thailand, 2 Chulalongkorn Hospital, Bangkok, Thailand, 3 sanofi pasteur, Marcy l’Etoile, France Abstract Background: Highly pathogenic influenza A/H5N1 has caused outbreaks in wild birds and poultry in Asia, Africa and Europe. It has also infected people, especially children, causing severe illness and death. Although the virus shows limited ability to transmit between humans, A/H5N1 represents a potential source of the next influenza pandemic. This study assesses the safety and immunogenicity of aluminium hydroxide adjuvanted (Al) and non adjuvanted influenza A/Vietnam/1194/2004 NIBRG-14 (H5N1) vaccine in children. Methods and Findings: In a Phase II, open, randomised, multicentre trial 180 children aged 6 months to 17 years received two injections, 21 days apart, of vaccine containing either: 30 mg haemagglutinin (HA) with adjuvant (30 mg+Al) or 7.5 mg HA without adjuvant. An additional 60 children aged 6–35 months received two ‘‘half dose’’ injections (ie 15 mg+Al or 3.8 mg). Safety was followed for 21 days after vaccination. Antibody responses were assessed 21 days after each injection and cellular immune responses were explored. Vaccination appeared well tolerated in all age groups. The 30 mg+Al formulation was more immunogenic than 7.5 mg in all age groups: in these two groups 79% and 46% had haemagglutinination inhibition antibody titres $32