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LIBRIS Formathandbok  (Information om MARC21)
FältnamnIndikatorerMetadata
00006114naa a2200733 4500
001oai:gup.ub.gu.se/50637
003SwePub
008240528s2006 | |||||||||||000 ||eng|
0247 a https://gup.ub.gu.se/publication/506372 URI
040 a (SwePub)gu
041 a eng
042 9 SwePub
072 7a ref2 swepub-contenttype
072 7a art2 swepub-publicationtype
1001 a Stephenson, I.4 aut
2451 0a Phase I evaluation of intranasal trivalent inactivated influenza vaccine with nontoxigenic Escherichia coli enterotoxin and novel biovector as mucosal adjuvants, using adult volunteers
264 1c 2006
520 a Trivalent influenza virus A/Duck/Singapore (H5N3), A/Panama (H3N2), and B/Guandong vaccine preparations were used in a randomized, controlled, dose-ranging phase I study. The vaccines were prepared from highly purified hemagglutinin and neuraminidase from influenza viruses propagated in embryonated chicken eggs and inactivated with formaldehyde. We assigned 100 participants to six vaccine groups, as follows. Three intranasally vaccinated groups received 7.5-microg doses of hemagglutinin from each virus strain with either 3, 10, or 30 microg of heat-labile Escherichia coli enterotoxin (LTK63) and 990 microg of a supramolecular biovector; one intranasally vaccinated group was given 7.5-microg doses of hemagglutinin with 30 microg of LTK63 without the biovector; and another intranasally vaccinated group received saline solution as a placebo. The final group received an intramuscular vaccine containing 15 microg hemagglutinin from each strain with MF59 adjuvant. The immunogenicity of two intranasal doses, delivered by syringe as drops into both nostrils with an interval of 1 week between, was compared with that of two inoculations by intramuscular delivery 3 weeks apart. The intramuscular and intranasal vaccine formulations were both immunogenic but stimulated different limbs of the immune system. The largest increase in circulating antibodies occurred in response to intramuscular vaccination; the largest mucosal immunoglobulin A (IgA) response occurred in response to mucosal vaccination. Current licensing criteria for influenza vaccines in the European Union were satisfied by serum hemagglutination inhibition responses to A/Panama and B/Guandong hemagglutinins given with MF59 adjuvant by injection and to B/Guandong hemagglutinin given intranasally with the highest dose of LTK63 and the biovector. Geometric mean serum antibody titers by hemagglutination inhibition and microneutralization were significantly higher for each virus strain at 3 and 6 weeks in recipients of the intramuscular vaccine than in recipients of the intranasal vaccine. The immunogenicity of the intranasally delivered experimental vaccine varied by influenza virus strain. Mucosal IgA responses to A/Duck/Singapore (H5N3), A/Panama (H3N2), and B/Guandong were highest in participants given 30 microg LTK63 with the biovector, occurring in 7/15 (47%; P=0.0103), 8/15 (53%; P=0.0362), and 14/15 (93%; P=0.0033) participants, respectively, compared to the placebo group. The addition of the biovector to the vaccine given with 30 microg LTK63 enhanced mucosal IgA responses to A/Duck/Singapore (H5N3) (P=0.0491) and B/Guandong (P=0.0028) but not to A/Panama (H3N2). All vaccines were well tolerated.
650 7a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Infektionsmedicin0 (SwePub)302092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Infectious Medicine0 (SwePub)302092 hsv//eng
650 7a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Mikrobiologi inom det medicinska området0 (SwePub)301092 hsv//swe
650 7a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Microbiology in the medical area0 (SwePub)301092 hsv//eng
653 a Adjuvants
653 a Immunologic/*administration & dosage
653 a Adolescent
653 a Adult
653 a Antibodies
653 a Viral/biosynthesis/blood
653 a Bacterial Toxins/administration & dosage/genetics/*immunology
653 a Enterotoxins/administration & dosage/genetics/*immunology
653 a Escherichia coli Proteins/administration & dosage/genetics/*immunology
653 a Hemagglutinin Glycoproteins
653 a 
653 a dosage/immunology
653 a Humans
653 a Immunity
653 a Mucosal
653 a Immunoglobulin A/biosynthesis/blood
653 a Immunoglobulin G/biosynthesis/blood
653 a Influenza A Virus
653 a H3N2 Subtype/*immunology
653 a Influenza Vaccines/administration & dosage/adverse effects/*immunology
653 a Injections
653 a Intramuscular
653 a Nasal Mucosa/*immunology/secretion
653 a Polysorbates/administration & dosage
653 a Single-Blind Method
653 a Squalene/administration & dosage/*immunology
653 a Vaccines
653 a Inactivated/administration & dosage/adverse effects/immunology
7001 a Zambon, M. C.4 aut
7001 a Rudin, Anna,d 1961u Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research4 aut0 (Swepub:gu)xrudan
7001 a Colegate, A.4 aut
7001 a Podda, A.4 aut
7001 a Bugarini, R.4 aut
7001 a Del Giudice, G.4 aut
7001 a Minutello, A.4 aut
7001 a Bonnington, S.4 aut
7001 a Holmgren, Jan,d 1944u Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi,Institute of Biomedicine, Department of Microbiology and Immunology4 aut0 (Swepub:gu)xholja
7001 a Mills, K. H.4 aut
7001 a Nicholson, K. G.4 aut
7102 a Göteborgs universitetb Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning4 org
7730 t J Virolg 80:10, s. 4962-70q 80:10<4962-70
8564 8u https://gup.ub.gu.se/publication/50637

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