Safety and immunogenicity of MF59-adjuvanted influenza vaccine in the elderly

Immunogenicity of intramuscular MF59-adjuvanted and intradermal administered influenza enhanced vaccines in subjects aged over 60: A literature review

“…Previous published studies have established that the immune response induced by IM-MF59 and ID potentiated vaccines, specially licensed for elderly people and marketed in Italy in 1997 and 2010 respectively, can be considered higher in elderly people as compared to conventional vaccines 4,28,29,35,[37][38][39][40]45,46,50,51,54,56,58,59 ; however, it is unclear if one of the 2 potentiated vaccines offers any advantages.…”

“…Protective HI titers higher than the generally accepted value of 40 were considered by Minutello et al 51 and De Donato et al 45 (HI 128) and Gasparini et al (HI 160). 4 With regard to responses against A/H3N2 antigen, the requested post-vaccination value of at least 60% of people with HI protective titers was always reached (range 70.8-100%) with 2 exceptions, both considering as protective titers higher than 40, Minutello et al 51 (third year of observation, 51%) and Gasparini $: data were reported as figures in the original paper.…”

“…4,30,31,35, These studies recruited subjects who would normally be candidates for routine seasonal influenza vaccination and the strain composition of the influenza vaccines used conformed to the yearly requirements of the World Health Organization. The population consisted of elderly subjects with and without underlying diseases, 30,35,[37][38][39][40][41][42]56,57 with unknown health status [43][44][45][46][47][48] or healthy. 4,31,[49][50][51][52][53][54][55] No sub-analyses were conducted to evaluate potential differences in the outcome between these groups.…”

“…42 The results of 13 clinical trials, representing an integrated development program of the manufacture, for a total of 2012 subjects vaccinated with IM-MF59 and 1498 with a comparator nonadjuvanted vaccine, reported in 2 meta-analyses 26,27 were not considered since results were reported as pooled analyses and expressed as IM-MF59 to comparator ratio. However, data from some of the 25 trials herein considered 4,38,45,51 are included in the 2 meta-analyses.…”

Influenza: vaccination and treatment

“…Influenza vaccine containing MF-59, an oil in water emulsion with squalene as the oil component and sorbitan trioleate (an oil soluble surfactant), was licensed in Italy in 1997 [55]. Comparative studies involving 4,100 subjects who were randomized to receive MF-59 adjuvanted trivalent vaccine or commercial comparator vaccines reveal significant increases of 5 -8% of subjects responding with fourfold increases in HAI antibody to H3N2, H1N1 and influenza B antigens adjuvanted with MF-59, in comparison with conventional vaccines, and the postvaccination geometric mean titres were 13 -31% higher (A. Podda, Chiron Vaccines, personal communication).…”