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news.Vaccine found to be safe to use with and without adjuvant
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BiondVax has completes the Phase I/II clinical trial of the Multimeric-001 Universal Flu vaccine. The trials were conducted at the Sourasky Medical Center in Tel Aviv, Israel.
The Phase I/II trial was a randomised, single-blind, placebo-controlled, escalating double-dose safety study in which a total of 60 participants, males and females aged 18-49, received two intramuscular injections containing the Multimeric-001 vaccine, either with or without adjuvant, and at two different dose levels.
The clinical trial results show that BiondVax’s Multimeric-001 Universal Flu vaccine is safe to use at all doses tested, both with and without adjuvant.
In addition, it was found that the Multimeric-001 Universal Flu vaccine activated, in a statistically significant manner when compared with placebo, the two arms of the human immune system – the humoral (antibody) arm and the cellular arm. All participants who received the vaccine showed a high level of antibodies against the Multimeric-001 Universal Flu vaccine. These antibodies also specifically identified a number of different strains of influenza, including the swine flu strain (A/H1N1).
In this Phase I/II clinical trial, certain cellular parameters were examined, and it was found that the Multimeric-001 Universal Flu vaccine caused, in a statistically significant manner when compared with placebo, an increase in the white blood cells of the immune system, inducing the secretion of Interferon Gamma and Interleukin-2, substances secreted by the immune system as part of the body’s cellular defense against pathogens.
Furthermore, it was found that BiondVax’s Multimeric-001 Universal Flu vaccine stimulated both humoral (antibody) and cellular responses against the two types of influenza: influenza type A and influenza type B, the types of flu which cause the flu disease in humans.
In the clinical trial it was found, in a statistically significant manner when compared with placebo, that the highest immunogenicity was observed when using the highest dose of the Multimeric-001 Universal Flu Vaccine with adjuvant, which was injected twice to the participants.