title: Immunogenicity and safety of a novel IL-2-supplemented liposomal influenza vaccine (INFLUSOME-VAC) in nursing-home residents.
abstract: Influenza and its complications account for substantial morbidity and mortality, especially among the elderly. In young adults, immunization provides 70-90% protection, while among the elderly the vaccine may be only </=50% effective; hence, the need for new, more immunogenic vaccines. We compared the safety and immunogenicity of a novel, interleukin-2 (IL-2) -supplemented trivalent liposomal influenza vaccine (designated INFLUSOME-VAC) with that of a commercial trivalent split virion vaccine in community-residing elderly volunteers (mean age 81 years) in winter of 2000/2001. Eighty-one individuals were randomly assigned to be vaccinated intramuscularly, either with the standard vaccine (n=33) or with INFLUSOME-VAC (n=48) prepared from the former. The two vaccines contained equal amounts of hemagglutinin (HA) ( approximately 15 microgram of each viral strain); INFLUSOME-VAC consisted of liposomal antigens admixed with liposomal human IL-2 (Lip IL-2) (33 microgram = 6x10(5) IU/dose). At 1 month post-vaccination, seroconversion rates (tested by hemagglutination inhibition) for the A/New Caledonia (H1N1) and A/Moscow (H3N2) strains were significantly higher (P=0.04) in the INFLUSOME-VAC group (65 versus 45%, 44 versus 24%, respectively). Moreover, INFLUSOME-VAC induced a greater anti-neuraminidase (NA-N2) response (P<0.05). Anti-IL-2 antibodies were undetected, and no increase in anti-phospholipid IgG antibodies was found in the INFLUSOME-VAC group. Adverse reactions were similar in both groups. Thus, INFLUSOME-VAC appears to be both safe and more immunogenic than the currently used vaccine in the elderly.
authors.affiliation: Department of Internal Medicine, Hadassah Medical Center, Jerusalem, 91120, 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: Yechezkel
authors.initials: Y
authors.lastname: Barenholz
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: Ilia
authors.initials: I
authors.lastname: Galprin
authors.forename: Reinhard
authors.initials: R
authors.lastname: Glück
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Zurbriggen
authors.forename: Eli
authors.initials: E
authors.lastname: Kedar
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D000368:Aged; D000818:Animals; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D000917:Antibody Formation / Q000276:immunology; D000956:Antigens, Viral / Q000032:analysis; D002467:Cell Nucleus / Q000276:immunology; D004311:Double-Blind Method; D005260:Female; D006385:Hemagglutination Inhibition Tests; D006801:Humans; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D007376:Interleukin-2 / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D008081:Liposomes; D008297:Male; D051379:Mice; D008807:Mice, Inbred BALB C; D009439:Neuraminidase / Q000037:antagonists & inhibitors / Q000276:immunology; D009735:Nursing Homes; D010743:Phospholipids / Q000276:immunology; D011786:Quality Control; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects; D014611:Vaccination
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D000956:Antigens, Viral; D007252:Influenza Vaccines; D007376:Interleukin-2; D008081:Liposomes; D010743:Phospholipids; D011994:Recombinant Proteins; D009439:Neuraminidase