Search: id:"swepub:oai:gup.ub.gu.se/50637" >
Phase I evaluation ...
Phase I evaluation of intranasal trivalent inactivated influenza vaccine with nontoxigenic Escherichia coli enterotoxin and novel biovector as mucosal adjuvants, using adult volunteers
- Article/chapterEnglish2006
Publisher, publication year, extent ...
Numbers
-
LIBRIS-ID:oai:gup.ub.gu.se/50637
-
https://gup.ub.gu.se/publication/50637URI
Supplementary language notes
Part of subdatabase
Classification
-
Subject category:ref swepub-contenttype
-
Subject category:art swepub-publicationtype
Notes
-
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.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
-
Zambon, M. C.
(author)
-
Rudin, Anna,1961Gothenburg University,Göteborgs universitet,Institutionen för medicin, avdelningen för reumatologi och inflammationsforskning,Institute of Medicine, Department of Rheumatology and Inflammation Research(Swepub:gu)xrudan
(author)
-
Colegate, A.
(author)
-
Podda, A.
(author)
-
Bugarini, R.
(author)
-
Del Giudice, G.
(author)
-
Minutello, A.
(author)
-
Bonnington, S.
(author)
-
Holmgren, Jan,1944Gothenburg University,Göteborgs universitet,Institutionen för biomedicin, avdelningen för mikrobiologi och immunologi,Institute of Biomedicine, Department of Microbiology and Immunology(Swepub:gu)xholja
(author)
-
Mills, K. H.
(author)
-
Nicholson, K. G.
(author)
-
Göteborgs universitetInstitutionen för medicin, avdelningen för reumatologi och inflammationsforskning
(creator_code:org_t)
Related titles
-
In:J Virol80:10, s. 4962-70
Internet link
Find in a library
To the university's database
- By the author/editor
-
Stephenson, I.
-
Zambon, M. C.
-
Rudin, Anna, 196 ...
-
Colegate, A.
-
Podda, A.
-
Bugarini, R.
-
show more...
-
Del Giudice, G.
-
Minutello, A.
-
Bonnington, S.
-
Holmgren, Jan, 1 ...
-
Mills, K. H.
-
Nicholson, K. G.
-
show less...
- About the subject
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Clinical Medicin ...
-
and Infectious Medic ...
-
- MEDICAL AND HEALTH SCIENCES
-
MEDICAL AND HEAL ...
-
and Basic Medicine
-
and Microbiology in ...
- Articles in the publication
- J Virol
- By the university
-
University of Gothenburg