A novel preservative‐free seasonal influenza vaccine safety and immune response study in the frame of preclinical research

Abstract

The paper describes the results of preclinical testing of the preparation "Vaccine allantoic split-virus inactivated against seasonal influenza." Acute toxicity and local irritating effect, anaphylactic reactions to different antigens (vaccine and ovalbumin), delayed-type hypersensitivity to ram erythrocytes, humoral immune response in hemaggtination reaction, immunogenic activity was studied in laboratory animals of various species (mice, rats, guinea pigs). Comparative analysis of the results from testing immunogenic activity of the preparation under study and the commercial influenza vaccines was performed. The preclinical testing has demonstrated safety and immune response of the seasonal split influenza vaccine, so it may be recommended for clinical study on limited contingent of volunteers.

Safety and immunogenicity of the novel seasonal preservative‐ and adjuvant‐free influenza vaccine: Blind, randomized, and placebo‐controlled trial

“…17,18 Adhering the principles of ITPIV project aimed at extension of available vaccine production, reduction in number of steps, and appropriate analytical trials the researchers of the RIBSP developed a preservative-and adjuvant-free vaccine against seasonal influenza. 19,14 One of solid arguments in favor of adjuvant-free vaccine is recommendation of annual immunization because of short duration of immune protection after single vaccination. 20 | 47…”

“…[11][12][13] To ensure seasonal influenza prophylaxis in the Republic of Kazakhstan the Research Institute for Biological Safety Problems has developed a seasonal influenza split vaccine that is available for manufacturing as well as reliable for safety and immunogenicity. 14…”

“…SafetyWithin May[11][12][13][14][15][16][17][18][19][20][21][22][23][24][25] 2016 in total 88 volunteers were screened for fitting inclusion/exclusion criteria of the trial. Anamneses of all screened persons were collected, physical examination of volunteers was carried out, their primary physiological characteristics were determined (height, weight, body temperature, blood pressure, pulse/ heart rate, and breathing rate), ECG data were obtained, venous blood for clinical, biochemical, and immunological assays was sampled, urine from all volunteers was analyzed, women were tested for pregnancy.…”

Immunogenicity and safety of a novel seasonal influenza preservative-free vaccine manufactured in Kazakhstan: Results of a randomized, comparative, phase II clinical trial in adults

“…15 The previous preclinical and phase I clinical trials of RIBSP vaccine showed excellent results in comparison with the split vaccine VAXIGRIP Ò . 10,11 The phase I clinical study of the vaccine in healthy subjects below 50 years of age showed good safe profile. Humoral immune response to the vaccine met three requirements of the European Committee to human influenza vaccines (CPMP/ EWP/214/96).…”

“…7,8 This vaccine is easily manufactured and was shown to be safe and highly immunogenic. [9][10][11] Application of RIBSP vaccine without adjuvants and preservatives makes it different from commercially available vaccines. We believe that the components of annually applied influenza vaccines (aluminium hydroxide, thiomersal etc.)…”