[Results of preclinical study of inactivated subunit adsorbed monovalent influenza vaccine "PANDEFLU"].
OBJECTIVE
To perform preclinical study of subunit monovalent adsorbed inactivated influenza vaccine "PANDEFLU" [strains A/California/7/2009 (HIN1)v].


METHODS
Preclinical study of acute toxicity on experimental animals (assessment of vaccine's toxic effects on organs and body systems; pathomorphologic study of organs and tissues after administration of the vaccine; assessment of its influence on hematologic indicators).


RESULTS
It was shown that administration of the vaccine did not lead to death of animals as well as to decrease of body mass or development of pathologic, focal sclerotic changes in parenchymal cells and visceral stroma; the vaccine did not negatively change hematologic and biochemical indicators of blood. Results of necropsy and histological study after acute administration of the vaccine in standard dose did not lead to irritation, inflammation or destruction of tissues in the place of inoculation. The vaccine was apyrogenic and did not have local irritating and allergenic effects. Status of animals after acute inoculation of the vaccine demonstrated its good tolerability and safety in doses exceeding standard human doses more than tenfold. CONCLUSION. Performed research demonstrated absence of contraindications for conduction of clinical trials of "PANDEFLU" vaccine on limited contingent of volunteers.
Mironov
A N
AN
Romanova
A A
AA
Dyldina
N V
NV
Bushmenkov
D S
DS
Tsaan
A A
AA
Alsynbaev
M M
MM
Zagidullin
N V
NV
Kolbasov
S E
SE
D000818:Animals; D006224:Cricetinae; D004353:Drug Evaluation, Preclinical; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D007252:Influenza Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D051379:Mice; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D022223:Vaccines, Subunit / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D022223:Vaccines, Subunit