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Clin. Vaccine Immunol. doi:10.1128/CVI.00316-07
Copyright (c) 2007, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Safety and immunogenicity of two influenza subunit vaccines, with or without MF59 adjuvant, administered to HIV-1 seropositive and seronegative adults

Department of Health Sciences, "San Martino" Hospital, University of Genoa, 16132 Genoa, Italy; Centre of Excellence for Biomedical Research, Department of Internal Medicine, University of Genoa, 16132 Genoa, Italy; San Patrignano Medical Centre, 47852 Coriano, Rimini, Italy; Stam Cells Centre, Pathologic Anatomy Unit, "San Martino" Hospital, 16132 Genoa, Italy; Department of Clinical and Experimental Medicine, University of Ferrara, 44100 Ferrara, Italy; Novartis Vaccines S.r.l., 53100 Siena, Italy

^* To whom correspondence should be addressed. Email: durando{at}unige.it.

	Abstract

The objective of this study was to evaluate and compare both the safety and tolerability and the humoral and cell-mediated immune response of two subunit influenza vaccines, adjuvanted with MF59 (Fluad ®) and non-adjuvanted (Agrippal ®), in healthy and in HIV-1 infected adult individuals.

To achieve this aim, an open, randomized, comparative clinical trial was performed during the 2005-2006 season. A total of 256 subjects were enrolled to receive intramuscularly one dose of the vaccines. Blood samples were taken at the time of vaccination, and at one and three months post-vaccination. A good humoral antibody response was detected for both vaccines, meeting all Committee for Medical Products for Human Use (CHMP) criteria. After Beyer's correction for pre-vaccination status, Fluad exhibited a better immunogenicity than Agrippal, as shown from the analysis of the Geometric Mean Titers, with significant differences for some virus strains: however no definitive conclusions on the clinical significance of such results can be drawn, as the method used to estimate antibody response is currently non-standard for influenza vaccines. A significant induction of antigenic-specific T CD4+ lymphocyte proliferative response was detected after immunization, at all time-points, for both the vaccines, among HIV-1 seronegative subjects. This was different from what was observed in HIV-1 infected individuals. In this group, significance was not reached at T30 in those immunized with Agrippal. Also comparing data between treatment groups, a clear difference in the response at T30 was observed in favor of Fluad (p=0.0002). The safety profile of both vaccines was excellent. In HIV-1 infected individuals, no significant changes both in viremia and in CD4+ cell-count were observed at all time-points.

Results showed good safety and immunogenicity for both vaccines under study in adults, both infected and not with HIV-1, confirming current recommendations for immunization of this high-risk category.