alexa Immunogenicity and Safety of an MF59®-Adjuvanted
ISSN: 2167-0870

Journal of Clinical Trials
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Research Article

Immunogenicity and Safety of an MF59®-Adjuvanted and a Non- Adjuvanted Inactivated Subunit Influenza Vaccine in Adults Affected by Chronic Diseases

Vincenzo Baldo1*, Tatjana Baldovin1, Gabriele Angiolelli1, Pantaleo Nacci2, Michele Pellegrini2, Derek O’Hagan2, Nicola Groth2 and Family Medicine Group of Pianiga3
1Department of Environmental Medicine and Public Health, Institute of Hygiene, University of Padua, Padua, Italy
2Novartis Vaccines and Diagnostics, Cambridge, USA
3Family Medicine Group of Pianiga, Venice, Italy consisting of the following medical practitioners: C. Barolo, C. Garzotto, I. Matiello and P. Marcato
Corresponding Author : Professor Vincenzo Baldo
Department of Environmental Medicine and Public Health
Institute of Hygiene
University of Padua
Via Loredan 18, 35131 Padua, Italy
Tel: +39 049 827 5381
Fax: +39 049 827 5392
E-mail: [email protected]
Received December 01, 2011; Accepted March 17, 2012; Published May 23, 2012
Citation: Baldo V, Baldovin T, Angiolelli G, Nacci P, Pellegrini M, et al. (2012) Immunogenicity and Safety of an MF59®-Adjuvanted and a Non-Adjuvanted Inactivated Subunit Influenza Vaccine in Adults Affected by Chronic Diseases. J Clin Trials 2:112. doi:10.4172/2167-0870.1000112
Copyright: © 2012 Baldo V, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
 

Abstract

Background: Influenza is a leading cause of morbidity and mortality in subjects with chronic diseases, who may also exhibit reduced immunogenicity to conventional influenza vaccines. MF59-adjuvanted influenza vaccine may enhance their immune response. Methods: We compared immunogenicity and safety of MF59-Adjuvanted Trivalent Influenza Vaccine (ATIV; Fluad®, Novartis Vaccines) and non-adjuvanted subunit (TIV; Agrippal®, Novartis Vaccines) in adults with at least one moderate to severe chronic condition. In this phase III, randomised, controlled, observer-blind study all subjects (18- 60 years of age) received one dose of ATIV (N=180) or TIV (N=179) vaccine during 2006/07 NH influenza season. Immunogenicity was tested using Hemagglutination Inhibition (HI) assay against vaccine and mismatched strains. Subjects were followed for safety for six months. Results: ATIV elicited significantly higher HI geometric mean titres (GMTs; P < .01) and mean-fold increases in titres (GMRs; P < .01) against all vaccine strains, compared with TIV. Seroprotection rates (HI ≥ 40) were 67–93% and 49–78% for ATIV and TIV groups, respectively (P < .01). ATIV also induced significantly higher GMTs against three mismatched strains (P < .05), and significantly greater GMRs against mismatched A strains (P < .05). Both influenza vaccines were well tolerated and safe, although ATIV elicited more solicited local and systemic (both 49%) reactions than TIV (both 28%). Most reactions (> 97%) were mild to moderate and all resolved spontaneously. Conclusion: ATIV is well tolerated, safe and confers higher and broader immunogenicity, when compared with a TIV, in adults with underlying chronic diseases.

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