Firm ready to advance towards human clinical trials
Results from a pre-clinical toxicology study of a Novavax vaccine candidate developed to prevent respiratory syncytial virus (RSV), showed it to be safe and well-tolerated at all doses tested. The vaccine uses highly purified recombinant particles of RSV-F fusion (RSV-F) protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
In this safety study, rabbits were immunised with a placebo or the RSV-F vaccine at a dose of 3 or 30µm with or without an aluminum phosphate adjuvant to boost immunogenicity. A placebo or vaccine was administered to each animal by intramuscular injection on days 1, 15 and 29. No vaccine-related adverse effects were observed other than mild and temporary local reactions at the injection site.
Dr Rahul Singhvi, chief executive of US-based Novavax, said: ‘We have now tested our RSV vaccine candidate in well-accepted animal models of toxicity and disease and found sufficient evidence of safety and effectiveness to advance our RSV vaccine candidate toward human clinical trials.
‘The results of this formal safety study are consistent with our previous findings and provide identification of a safe dose for testing in a Phase I clinical study. We believe that these results, and our overall pre-clinical package, moves us one step closer to filing an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA).’
RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young children worldwide. Repeated infections occur throughout life causing moderate to severe cold-like symptoms.
More severe lower respiratory tract disease is also seen in elderly adults over age 65 years, similar to the severe illness witnessed in children.
It is estimated that RSV infects more than 8.5 million adults annually, including the elderly over age 65 years.