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Recombinant Respiratory Syncytial Virus Pre-Fusion F Protein, adjuvanted with AS01E, is an investigational vaccine. The full registry name is RECOMBINANT RESPIRATORY SYNCYTIAL VIRUS PRE-FUSION F PROTEIN, ADJUVANTED WITH AS01E. It is a protein-based substance produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cells.[3] The active substance is a form of the respiratory syncytial virus (RSV) F protein stabilised in its pre-fusion conformation.[3] In the product records for the trial described on this page, the substance has no marketing authorisation, meaning it is still being studied rather than sold as an approved medicine.[1] The applicant named in the paediatric investigation plan is GlaxoSmithKline UK Limited, and the invented name for the vaccine is Arexvy.[2]
The vaccine presents the RSV F protein in its pre-fusion shape, which is the form the virus uses before it enters human cells. The F protein is produced in Chinese Hamster Ovary cells by recombinant DNA technology and stabilised so that the immune system can recognise it.[3] An adjuvant called AS01E is added to strengthen the immune response.[2] When the vaccine is injected, the body learns to recognise the pre-fusion F protein and can produce neutralising antibodies against RSV subtypes A and B. The Phase 3 trial measured RSV-A and RSV-B neutralising antibody titres one month after vaccination.[1]
The vaccine is a suspension for injection given by the intramuscular route.[1] In the Phase 3 trial, the dose was 0.5 ml given intramuscularly.[1] The MHRA paediatric investigation plan lists the pharmaceutical form as powder and suspension for suspension for injection.[2] The European Medicines Agency assessment report also lists powder and suspension for suspension for injection, with a strength of 120 µg / 0.5 ml for intramuscular use.[3]
One completed Phase 3 trial investigated this vaccine. The study was open-label, randomised and controlled, and enrolled 1,142 adults aged 60 years and older.[1] The trial evaluated the immune response, safety and reactogenicity of the RSV pre-fusion F protein vaccine when co-administered with a 20-valent pneumococcal conjugate vaccine (PCV20).[1]
The Phase 3 trial measured safety and reactogenicity of the vaccine when co-administered with PCV20.[1] The supplementary sources provided for this page do not list specific side effects for this exact adjuvanted formulation, so no side-effect frequencies are reported here.
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