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Vaccination of Macaques with Adjuvanted Formalin-Inactivated Influenza A Virus (H5N1) Vaccines: Protection against H5N1 Challenge without Disease Enhancement

Research Department, sanofi pasteur, Marcy L'Etoile, France,¹ Aventis-Pharma, Sanofi-Aventis, Alfortville, France,² ViroClinics BV, Rotterdam, The Netherlands,³ Erasmus Medical Center, Rotterdam, The Netherlands⁴

Received 4 September 2007/ Accepted 12 December 2007

We investigated the ability of adjuvanted, inactivated split-virion influenza A virus (H5N1) vaccines to protect against infection and demonstrated that the disease exacerbation phenomenon seen with adjuvanted formaldehyde-inactivated respiratory syncytial virus and measles virus investigational vaccines did not occur with these H5N1 vaccines. Macaques were vaccinated twice with or without an aluminum hydroxide or oil-in-water emulsion adjuvanted vaccine. Three months later, animals were challenged with homologous wild-type H5N1. No signs of vaccine-induced disease exacerbation were seen. With either adjuvant, vaccination induced functional and cross-reactive antibodies and protected the lungs and upper respiratory tract. Without an adjuvant, the vaccine provided partial protection. Best results were obtained with the emulsion adjuvant.

Published ahead of print on 19 December 2007.