title: Safety of a nasal vaccine against Streptococcus pneumoniae using heat-killed Lactobacillus casei as adjuvant.
abstract: Streptococcus pneumoniae is a highly important respiratory pathogen that causes infections in children, elderly people and immunocompromised people around the world. Pneumococcal vaccines licensed did not reach to eradicate the pneumococcal infection. In a previous study was demonstrated the effectiveness of a nasal experimental vaccine that consisted in a pneumococcal protective protein A (PppA) co-administrated with heat-killed-Lactobacillus casei (LcM), in mice model of respiratory pneumococcal challenge. In the present work the safety of the experimental vaccine LcM+PppA and its components were evaluated through hematological, biochemical and immune parameters in a model infection with S. pneumoniae. Thus, alanine transaminase activity, creatinine levels, lactate dehydrogenase activity, C reactive protein levels, corticosterone levels in serum, total and differential leukocyte counts in blood and bronchoalveolar lavages (BAL) and IgE in BAL, were evaluated. Experimental vaccine: LcM+PppA nasally administered does not induce harmful effects in our vaccination-infection model. Studied parameters showed LcM+PppA's safety in liver, kidney, pulmonary and systemic levels. Although studies in experimental animals do not guarantee security for the application of the vaccine on humans, they are important evidence for the planning and subsequent clinical trials in humans.
authors.affiliation: Instituto de Bioquímica Aplicada, Facultad de Bioquímica, Química y Farmacia, Universidad Nacional de Tucumán-CONICET, Balcarce 747, CP 4000 San Miguel de Tucumán, Tucumán, Argentina. Electronic address: mgalmada@ucdavis.edu.
authors.forename: Guillermina
authors.initials: G
authors.lastname: Almada
authors.affiliation: Instituto de Bioquímica Aplicada, Facultad de Bioquímica, Química y Farmacia, Universidad Nacional de Tucumán-CONICET, Balcarce 747, CP 4000 San Miguel de Tucumán, Tucumán, Argentina. Electronic address: anaharo@fbqf.unt.edu.ar.
authors.forename: Cecilia
authors.initials: C
authors.lastname: Haro
authors.affiliation: LARIVENOA,Facultad de Agronomía y Zootecnia. Universidad Nacional de Tucumán. Florentino Ameghino S/N. CP: 4105, San Miguel de Tucumán, Tucumán, Argentina. Electronic address: eovintini14@yahoo.com.ar.
authors.forename: Elisa
authors.initials: E
authors.lastname: Vintiñi
authors.affiliation: Instituto de Microbiología, Facultad de Bioquímica, Química y Farmacia, Universidad Nacional de Tucumán-CONICET, Ayacucho 471, CP 4000 San Miguel de Tucumán, Tucumán, Argentina. Electronic address: marcemedina74@yahoo.com.ar.
authors.forename: Marcela
authors.initials: M
authors.lastname: Medina
mesh_terms: D000276:Adjuvants, Immunologic; D000281:Administration, Intranasal; D000818:Animals; D001992:Bronchoalveolar Lavage Fluid / Q000166:cytology / Q000276:immunology; D002097:C-Reactive Protein / Q000378:metabolism; D003345:Corticosterone / Q000378:metabolism; D004195:Disease Models, Animal; D007073:Immunoglobulin E / Q000276:immunology; D007677:Kidney Function Tests; D007780:Lacticaseibacillus casei / Q000276:immunology*; D007958:Leukocyte Count; D008111:Liver Function Tests; D008297:Male; D051379:Mice; D011008:Pneumococcal Infections / Q000378:metabolism / Q000517:prevention & control*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012129:Respiratory Function Tests; D013296:Streptococcus pneumoniae / Q000276:immunology*; D013312:Stress, Physiological; D015164:Vaccines, Inactivated
chemical_list: D000276:Adjuvants, Immunologic; D022242:Pneumococcal Vaccines; D015164:Vaccines, Inactivated; D007073:Immunoglobulin E; D002097:C-Reactive Protein; D003345:Corticosterone
keywords: Adjuvant; Heat killed-L. casei; Nasal vaccine; S. pneumoniae; Vaccine safety