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Vaccine. 2011 Sep 21. [Epub ahead of print]
A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems.
Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky MD, Cardoso MR, Luna E, Mondini G, Guedes JD, Raw I.
Source
Butantan Institute/Butantan Foundation, Clinical Trials Unit, S?o Paulo, Brazil; Pediatrics Department, Instituto da Crian?a do Hospital das Cl?nicas da Faculdade de Medicina da Universidade de S?o Paulo, S?o Paulo, Brazil.
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: 15μg of hemagglutinin antigen without adjuvant; 7.5μg of hemagglutinin antigen with aluminum hydroxide, MPL and squalene; 3.75μg of hemagglutinin antigen with aluminum hydroxide and MPL; and 3.75μg 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.
Copyright ? 2011 Elsevier Ltd. All rights reserved.
PMID:
21945258
[PubMed - as supplied by publisher]
A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems.
Precioso AR, Miraglia JL, Campos LM, Goulart AC, Timenetsky MD, Cardoso MR, Luna E, Mondini G, Guedes JD, Raw I.
Source
Butantan Institute/Butantan Foundation, Clinical Trials Unit, S?o Paulo, Brazil; Pediatrics Department, Instituto da Crian?a do Hospital das Cl?nicas da Faculdade de Medicina da Universidade de S?o Paulo, S?o Paulo, Brazil.
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: 15μg of hemagglutinin antigen without adjuvant; 7.5μg of hemagglutinin antigen with aluminum hydroxide, MPL and squalene; 3.75μg of hemagglutinin antigen with aluminum hydroxide and MPL; and 3.75μg 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.
Copyright ? 2011 Elsevier Ltd. All rights reserved.
PMID:
21945258
[PubMed - as supplied by publisher]
