Novavax’s VLP Vaccine Shows Positive Result

Reportedly, the study enrolled 241 subjects, including 221 who were randomised to receive either VLP vaccine at 15mcg or 60mcg doses or a placebo and 20 subjects who received a licensed inactivated influenza vaccine (TIV).

Novavax has reported safety and hemagglutination inhibition (HAI) antibody titers from the study in a poster presentation at the 47th Annual Meeting of the Infectious Diseases Society of America (IDSA).

In addition to the HAI titers, functional antibody against the Neuraminidase enzyme was measured in the sera of immunised subjects using a neuraminidase inhibition assay (NAI) developed by Novavax scientists.

In continued evaluation of the May 2009 clinical study, Novavax has tested volunteers for NAI against H3N2/Brisbane and B/Florida components of the vaccine before and after immunisation. The results showed that 50 to 73% of the volunteers immunised with the Novavax VLP vaccine had a 4-fold increase in the antibody that blocks neuraminidase activity. In contrast, only 1 of 19 volunteers that received the TIV showed a 4-fold rise for NAI. There was no 4-fold rise in volunteers that received placebo.

Rahul Singhvi, president and CEO of Novavax, said: “These are very exciting results which not only support continued development of novel VLP vaccines against influenza but also provides a cornerstone to potentially differentiate our vaccine from the current standard of care. We will continue to evaluate NAI responses in additional clinical trials particularly in the ongoing study in the elderly and work to optimise the NA activity required in our vaccine to maximise NAI responses.

“We believe these new data reinforce our long standing thesis that VLP influenza vaccines have the potential to induce broad immunity that could lead to meaningful reduction in the burden of disease.”