Evaluation of a virosomal H5N1 vaccine formulated with Matrix M?adjuvant in a phase I clinical trial

详细信息    查看全文

• 作者：Rebecca J. Cox^a ; ^b ; ^{rebecca.cox@gades.uib.no} ; Gabriel Pedersen^a ; Abdullah S. Madhun^a ; Signe Svindland^a ; Marianne Sæ ; vik^c ; Lucy Breakwell^d ; Katja Hoschler^d ; Marieke Willemsen^e ; Laura Campitelli^f ; Jane Kristin Nø ; stbakken^a ; Gerrit Jan Weverling^e ; Jaco Klap^e ; Kenneth C. McCullough^g ; Maria Zambon^d ; Ronald Kompier^e ; Haakon Sjursen^c ; ^h
• 关键词：Matrix M ; Influenza H5N1 ; Cross-reactivity ; Antibody response ; HI ; MN ; SRH
• 刊名：Vaccine
• 出版年：2011
• 出版时间：19 October, 2011
• 年：2011
• 卷：29
• 期：45
• 页码：8049-8059
• 全文大小：1K

文摘

The avian influenza H5 virus epizootic continues to cause zoonosis with human fatalities, highlighting the continued need for pandemic preparedness against this subtype. This study evaluated the tolerability and immunogenicity of a Matrix M?adjuvanted virosomal H5N1 vaccine in a phase I clinical trial. Sixty healthy adults were vaccinated intramuscularly with two doses of influenza H5N1 (NIBRG-14) virosomal vaccine alone (30 ¦Ìg haemagglutinin (HA)) or 1.5, 7.5 or 30 ¦Ìg HA formulated with 50 ¦Ìg Matrix M?adjuvant. The antibody response was analysed by haemagglutination inhibition (HI), microneutralisation (MN) and single radial haemolysis (SRH) assays. The vaccine was well tolerated in all groups but injection site pain was more frequently observed in the Matrix M?adjuvanted groups. The vaccine elicited homologous and heterologous H5N1-specific antibody responses and the Matrix M?adjuvanted formulations met all the EU regulatory criteria. In conclusion, Matrix M?adjuvant was well tolerated and augmented the antibody response allowing considerable dose sparing down to 1.5 ¦Ìg HA.