A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for a soluble glycoprotein vaccine to prevent disease caused by Nipah or Hendra viruses

                                            

vaccines LLC has developed a protein vaccine to prevent diseases caused by Nipah and Hendra virus infections, which uses recombinant soluble Hendra glycoprotein (HeVsG) adulated with aluminum phosphate. The vaccine is currently under clinical evaluation in a phase 1 study. The Technical Working Group (BRAVATO; exV3SWG) has prepared a standardized template for the risk assessment of the benefits of vaccines to describe the key considerations for the evaluation of risks of the benefits of protein vaccines. This will help key stakeholders assess potential safety issues and understand the profit risk of such vaccine platforms. The structured and standardized evaluation provided by the staff can also help increase public acceptance and communication of licensed protein vaccines. Protein vaccines usually contain viral surface antigens that are responsible for stimulating neutralizing antibodies. They are usually recombinant and highly purified. Peptides are also included in this type of vaccine, most of which are likely to be synthetic. Examples of licensed protein vaccines include influenza vaccines containing highly purified recombinant hemagglutinin and shingles vaccines containing highly purified varicella-zoster surface glycoprotein E antigen. Many other protein vaccines, such as HIV gp120 and gp140, have been tested for clinical vaccines but have not yet been licensed. Recombinant proteins have been used in protein boost and vector or DNA immunization programs, especially HIV vaccines. Some recombinant virus antigens spontaneously assemble into virus-like particles (VLPs). Compared to purified protein antigens, these can be single or multiple protein structures that are stable and more immunogenic. Examples of licensed vaccines containing recombinant VLP include hepatitis B and human papillomavirus vaccines [5]. It should be noted that, compared to inactivated, live attenuated vaccines and viral vectors, the production of protein vaccines does not involve the cultivation of any live virus nor does it contain any viral genome. Therefore, their production and quality control are simpler and are generally considered safer in cases where the virus can establish persistent infection or carcinogenicity and can be manufactured even if the virus cannot be cultured. Commercial recombinant protein vaccines have been shown to be safe and effective, and their production can be scaled up relatively easily. However, due to the limited immunogenicity of certain protein vaccines in humans, their development has also focused on methods to enhance the immune response, through the use of adjuvants, optimizing the route or method of administration, and the use of heterologous immune 

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