ABSTRACT
In March 2013 it was reported by the World Health Organization (WHO) the first cases of human infections with avian influenza virus A (H7N9). From 2013 to December 2019, 1568 cases have been reported with 616 deaths. H7N9 infection has been associated with high morbidity and mortality rates, and vaccination is currently the most effective way to prevent infections and consequently flu-related severe illness. Developing and producing vaccines against pandemic influenza viruses is the main strategy for a response to a possible pandemic. This study aims to present the production of three industrial lots under current Good Manufacturing Practices (cGMP) of the active antigen used to produce the pandemic influenza vaccine candidate against A(H7N9). These batches were characterized and evaluated for quality standards and tested for immunogenicity in mice. The average yield was 173.50 ± 7.88 µg/mL of hemagglutinin and all the preparations met all the required specifications. The formulated H7N9 vaccine is poorly immunogenic and needs to be adjuvanted with an oil in water emulsion adjuvant (IB160) to achieve a best immune response, in a prime and in a boost scheme. These data are important for initial production planning and preparedness in the case of a H7N9 pandemic.
Subject(s)
Influenza A Virus, H7N9 Subtype/immunology , Influenza Vaccines/biosynthesis , Influenza, Human/prevention & control , Pandemics/prevention & control , Animals , Antigens, Viral/biosynthesis , Antigens, Viral/immunology , Drug Compounding/methods , Drug Compounding/statistics & numerical data , Drug Industry/standards , Female , Humans , Influenza Vaccines/immunology , Influenza Vaccines/isolation & purification , Influenza, Human/immunology , Influenza, Human/virology , Mice , Mice, Inbred BALB C , Vaccines, Inactivated/biosynthesis , Vaccines, Inactivated/immunology , Vaccines, Inactivated/isolation & purificationABSTRACT
Adhesins need to be exposed on the surface of pathogenic bacteria to properly interact with host tissues and allow establishment of the infection. This fact implies that, in theory, one could manage or avoid infection by controlling adhesins' function, and also by indirectly detecting bacteria through their surface-exposed adhesins. Besides, binding of anti-adhesin immunoglobulins on the bacterial surface tend to promote the opsonization of the pathogen. Therefore, bacterial adhesins represent a great target to develop new biopharmaceuticals, which may become commercially and medically important products. In this review, we will summarize the biological importance of bacterial adhesins, and also discuss some recent patents related to these molecules, as well as their use and possible new future developments in this area.
