A phase I randomized, double-blind, controlled trial of 2009 influenza A(H1N1) inactivated monovalent vaccines with different adjuvant systems

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dc.contributor Sistema FMUSP-HC: Faculdade de Medicina da Universidade de São Paulo (FMUSP) e Hospital das Clínicas da FMUSP
dc.contributor.author PRECIOSO, Alexander R. FMUSP-HC
MIRAGLIA, Joao L.
CAMPOS, Lucia Maria A. FMUSP-HC
GOULART, Alessandra C. FMUSP-HC
TIMENETSKY, Maria do Carmo S. T.
CARDOSO, Maria Regina A.
LUNA, Expedito FMUSP-HC
MONDINI, Gabriella
GUEDES, Jose da S.
RAW, Isaias
dc.date.issued 2011
dc.identifier.citation VACCINE, v.29, n.48, p.8974-8981, 2011
dc.identifier.issn 0264-410X
dc.identifier.uri http://observatorio.fm.usp.br/handle/OPI/24158
dc.description.abstract Methods: We conducted a phase I, multicenter, randomized, double-blind, placebo-controlled, multi-arm (10) parallel study involving healthy adults to evaluate the safety and immunogenicity of influenza A (H1N1) 2009 non-adjuvanted and adjuvanted candidate vaccines. Subjects received two intramuscular injections of one of the candidate vaccines administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay before and 21 days after each vaccination. The three co-primary immunogenicity end points were the proportion of seroprotection >70%, seroconversion >40%, and the factor increase in the geometric mean titer >2.5. Results: A total of 266 participants were enrolled into the study. No deaths or serious adverse events were reported. The most commonly solicited local and systemic adverse events were injection-site pain and headache, respectively. Only three subjects (1.1%) reported severe injection-site pain. Four 2009 influenza A (H1N1) inactivated monovalent candidate vaccines that met the three requirements to evaluate influenza protection, after a single dose, were identified: 15 mu g of hemagglutinin antigen without adjuvant; 7.5 mu g of hemagglutinin antigen with aluminum hydroxide, MPL and squalene: 3.75 mu g of hemagglutinin antigen with aluminum hydroxide and MPL; and 3.75 mu g of hemagglutinin antigen with aluminum hydroxide and squalene. Conclusions: Adjuvant systems can be safely used in influenza vaccines, including the adjuvant monophosphoryl lipid A (MPL) derived from Bordetella pertussis with squalene and aluminum hydroxide, MPL with aluminum hydroxide, and squalene and aluminum hydroxide.
dc.description.sponsorship · Butantan Foundation
dc.language.iso eng
dc.publisher ELSEVIER SCI LTD
dc.relation.ispartof Vaccine
dc.rights restrictedAccess
dc.subject 2009 Influenza A(H1N1) vaccine; Adjuvants; Clinical trial; Phase I
dc.subject.other monophosphoryl-lipid-a; dendritic cells; immune-response; h1n1 vaccine; mf59-adjuvanted vaccine; pandemic influenza; aluminum adjuvants; nalp3 inflammasome; split-virion; work
dc.title A phase I randomized, double-blind, controlled trial of 2009 influenza A(H1N1) inactivated monovalent vaccines with different adjuvant systems
dc.type article
dc.rights.holder Copyright ELSEVIER SCI LTD
dc.description.group LIM/36
dc.description.group LIM/51
dc.identifier.doi 10.1016/j.vaccine.2011.09.040
dc.identifier.pmid 21945258
dc.type.category original article
dc.type.version publishedVersion
hcfmusp.author PRECIOSO, Alexander R.:HC:ICR
hcfmusp.author CAMPOS, Lucia Maria A.:HC:ICR
hcfmusp.author GOULART, Alessandra C.:HU:SCPACEX-62
hcfmusp.author LUNA, Expedito:IMT:IMT
hcfmusp.author.external · MIRAGLIA, Joao L.:Butantan Fdn, Butantan Inst, Clin Trials Unit, BR-05503000 Sao Paulo, Brazil
· TIMENETSKY, Maria do Carmo S. T.:Adolfo Lutz Inst, Sao Paulo, Brazil
· CARDOSO, Maria Regina A.:Univ Sao Paulo, Fac Saude Publ, Dept Epidemiol, BR-01255 Sao Paulo, Brazil
· MONDINI, Gabriella:Butantan Fdn, Butantan Inst, Clin Trials Unit, BR-05503000 Sao Paulo, Brazil
· GUEDES, Jose da S.:Butantan Fdn, Butantan Inst, Clin Trials Unit, BR-05503000 Sao Paulo, Brazil
· RAW, Isaias:Butantan Fdn, Butantan Inst, Clin Trials Unit, BR-05503000 Sao Paulo, Brazil
hcfmusp.origem.id WOS:000297601200028
hcfmusp.origem.id 2-s2.0-82455198738
hcfmusp.publisher.city OXFORD
hcfmusp.publisher.country ENGLAND
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dc.description.index MEDLINE
dc.identifier.eissn 1873-2518
hcfmusp.citation.scopus 11
hcfmusp.citation.wos 11
hcfmusp.affiliation.country Brasil


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