title: Immunogenicity and safety of a novel liposomal influenza subunit vaccine (INFLUSOME-VAC) in young adults.
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 (approximately 15 microg 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 < or = 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.
authors.affiliation: Department of Internal Medicine, Hebrew University-Hadassah Medical School and Hadassah Hospital, Jerusalem, Israel. benyehuda@hadassah.org.il
authors.forename: Arie
authors.initials: A
authors.lastname: Ben-Yehuda
authors.forename: Aviva
authors.initials: A
authors.lastname: Joseph
authors.forename: Evelyne
authors.initials: E
authors.lastname: Zeira
authors.forename: Simcha
authors.initials: S
authors.lastname: Even-Chen
authors.forename: Igal
authors.initials: I
authors.lastname: Louria-Hayon
authors.forename: Ilan
authors.initials: I
authors.lastname: Babai
authors.forename: Zichria
authors.initials: Z
authors.lastname: Zakay-Rones
authors.forename: Evgenia
authors.initials: E
authors.lastname: Greenbaum
authors.forename: Yechezkel
authors.initials: Y
authors.lastname: Barenholz
authors.forename: Eli
authors.initials: E
authors.lastname: Kedar
mesh_terms: D000293:Adolescent; D000328:Adult; D000818:Animals; D005260:Female; D019267:Hemagglutinin Glycoproteins, Influenza Virus / Q000276:immunology; D006801:Humans; D009980:Influenza A virus / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D007376:Interleukin-2 / Q000235:genetics / Q000276:immunology; D008081:Liposomes / Q000276:immunology; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D009439:Neuraminidase / Q000276:immunology; D011994:Recombinant Proteins / Q000276:immunology
chemical_list: D019267:Hemagglutinin Glycoproteins, Influenza Virus; D007252:Influenza Vaccines; D007376:Interleukin-2; D008081:Liposomes; D011994:Recombinant Proteins; D009439:Neuraminidase