title: [The evaluation of the reactogenicity and immunogenic activity of a new concentrated inactivated leptospirosis vaccine].
abstract: In the controlled field trial the reactogenicity, safety and antigenic activity of a new concentrated inactivated leptospirosis vaccine after its administration in one and two injections of 0.5 ml were studied in comparison with those of the existing commercial vaccine, introduced in two injections in doses of 2.0 and 2.5 ml. The new experimental vaccine exhibited low reactogenicity and was found to be safe and highly immunogenic when introduced in a single injection of 0.5 ml. As shown in this trial, the immunogenic characteristics of immunization made in a single injection were not inferior than those obtained as the result of immunization made in two injections, yielding high percentage of seroconversions (89.8% to 98.3%) with respect to 4 Leptospira serogroups and leading to the production of the protective titers of corresponding antibodies. The existing commercial vaccine was inferior to the experimental one in antigenic activity (the frequency of seroconversions, antibody titers). The results of the trial make it possible to recommend the experimental concentrated leptospirosis vaccine for use in medical practice in a dose of 0.5 ml introduced in a single injection.
authors.affiliation: Tarasevich State Research Institute for Standardization and Control of Medical Biological Preparations, Moscow, Russia.
authors.forename: V N
authors.initials: VN
authors.lastname: Ikoev
authors.forename: M A
authors.initials: MA
authors.lastname: Gorbunov
authors.forename: B F
authors.initials: BF
authors.lastname: Vachaev
authors.forename: E A
authors.initials: EA
authors.lastname: Iagovkin
authors.forename: V F
authors.initials: VF
authors.lastname: Kondratenko
authors.forename: Iu V
authors.initials: IuV
authors.lastname: Anan'ina
authors.forename: T I
authors.initials: TI
authors.lastname: Ansimova
authors.forename: N I
authors.initials: NI
authors.lastname: Kostina
authors.forename: I L
authors.initials: IL
authors.lastname: Iur'eva
authors.forename: M G
authors.initials: MG
authors.lastname: Nikitin
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001428:Bacterial Vaccines / Q000009:adverse effects* / Q000276:immunology; D006801:Humans; D007919:Leptospira / Q000276:immunology*; D007921:Leptospira interrogans / Q000276:immunology*; D007922:Leptospirosis / Q000517:prevention & control*; D013997:Time Factors; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000009:adverse effects / Q000276:immunology; D014895:Weil Disease / Q000517:prevention & control*
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D017778:Vaccines, Combined; D015164:Vaccines, Inactivated
vernacular_title: Otsenka reaktogennosti i immunogennoĭ aktivnosti novoĭ kontsentrirovannoĭ inaktivirovannoĭ leptospiroznoĭ vaktsiny.