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Immunogenicity and safety of a novel liposomal influenza subunit vaccine (INFLUSOME-VAC) in young adults

✍ Scribed by Arie Ben-Yehuda; Aviva Joseph; Evelyne Zeira; Simcha Even-Chen; Igal Louria-Hayon; Ilan Babai; Zichria Zakay-Rones; Evgenia Greenbaum; Yechezkel Barenholz; Eli Kedar


Publisher
John Wiley and Sons
Year
2003
Tongue
English
Weight
91 KB
Volume
69
Category
Article
ISSN
0146-6615

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✦ Synopsis


Abstract

Influenza and its complications account for substantial morbidity and mortality among young adults and especially among the elderly. In young adults, immunization provides 70–90% protection, while among the elderly the vaccine may be only 30–40% effective; hence the need for new, more immunogenic vaccines. We compared the safety and immunogenicity of a novel IL‐2‐supplemented liposomal influenza vaccine (designated INFLUSOME‐VAC) with that of a commercial subunit vaccine and a commercial split virion vaccine in young adults (mean age 28 years) in the winter of 1999–2000. Seventy‐three healthy young adults were randomly assigned to be vaccinated intramuscularly with the following: a commercial subunit vaccine (n = 17, group A), INFLUSOME‐VAC (n = 36, group B), and a commercial split virion vaccine (n = 20, group C). The three vaccines contained equal amounts of hemagglutinin (∼15 μg each) from the strains A/Sydney (H3N2), A/Beijing (H1N1), and B/Yamanashi. INFLUSOME‐VAC induced higher geometric mean HI titers and higher‐fold increases in HI titers against all three strains, compared with the two commercial vaccines. In addition, seroconversion rates for the A/Sydney and B/Yamanashi strains were significantly higher (P < 0.05) compared with the split virion vaccine, and significantly higher for the three strains compared with the subunit vaccine (69–97% vs 35–65%, P ≤ 0.02). Moreover, the anti‐neuraminidase response was significantly greater (P = 0.05) in group B vs group A. INFLUSOME‐VAC caused mild local pain at the injection site in a significantly higher proportion of the vaccinees (83%). Thus, INFLUSOME‐VAC is an immunogenic and safe vaccine in young adults. J. Med. Virol. 69:560–567, 2003. © 2003 Wiley‐Liss, Inc.