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

Abstract

The producers of influenza vaccines are not capable today to meet the global demand for an influenza vaccine in case of pandemic, so the World Health Organization recommends to develop the own influenza vaccine production in each country. A domestic preservative- and adjuvant-free trivalent split vaccine against seasonal influenza was developed at the Research Institute for Biological Safety Problems. The paper presents the results of assessing safety and immunogenicity of the influenza split vaccine after single immunization of healthy volunteers aged 18-50 years in the course of Phase I Clinical Trials. This study was randomized, blind, and placebo-controlled. The volunteers were intramuscularly vaccinated with a dose of split vaccine or placebo. The study has shown that all local and systemic reactions had low degree of manifestation and short-term character, so there was no need in medication. Serious side effects were not observed. On day 21 post vaccination the portion of vaccinated persons with fourfold seroconversions to influenza А/H1N1pdm09 virus was 100.0%, to influenza А/H3N2 virus-95.5%, to influenza B virus-81.8%, and in placebo group this index was 0%. Seroprotection rates against influenza А/H1N1pdm09, А/H3N2 and B viruses were 95.5, 86.3, and 72.7%, respectively. Geometric mean titers (GMT) of antibodies by day 21 post vaccination reached 175.7 for influenza А/H1N1pdm09 virus, 64.2 for influenza А/H3N2 virus, and 37.6 for influenza B virus; in placebo group GMT growth was not observed. So, the seasonal influenza split vaccine is well tolerated and fits all immunogenicity criteria for human influenza vaccines.

Adjuvanted influenza vaccines

“…In healthy adults, inactivated influenza vaccines are mostly immunogenic (for example [6][7][8][9] ). Indeed until 2015, in the EU, influenza vaccines were evaluated by serological tests alone and licensed on >70% of individuals achieving a haemagglutination-inhibition (HAI) titre of >1:40 and a four-fold increase in HAI titre in >40% of individuals.…”

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

“…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.)…”

“…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).…”

“…Humoral immune response to the vaccine met three requirements of the European Committee to human influenza vaccines (CPMP/ EWP/214/96). 11,16 21 days post vaccination (DPV) seroconversion rate was 100.0% to influenza virus A/H1N1pdm09, 95.5% to influenza virus A/H3N2 and 81.8% to influenza B virus. Seroprotection level against influenza viruses A/H1N1pdm09, A/H3N2 and type % was 95.5%, 86.3% and 72.7, respectively.…”

“…Geometric mean titers (GMT) of antibodies on 21 DPV were 175.7 for influenza virus A/H1N1pdm09, 64.2 for influenza virus A/H3N2 and 37.6 for influenza B virus. 11 The results of phase II clinical trials of RIBSP vaccine are promising for the optimization of influenza vaccine production for middle-or low-income countries and can make a significant contribution to the global influenza prevention program.…”