Development of a Virus-Like Particle (VLP) Vaccine Against the Novel Influenza A (H1N1) Virus in 12 Weeks or Less
A novel influenza A (H1N1) virus was first detected in April 2009 in Mexico, the United States and Canada and has rapidly spread to other countries. This outbreak reflects the urgent need to develop new vaccines rapidly in the early stages of a pandemic and produce them quickly to reduce the spread of the virus and protect public health. Novavax believes that its VLP-vaccine technology has the potential to meet this need and produce a vaccine against the novel influenza A H1N1 in 12 weeks or less.
Genetic Engineering Phase (COMPLETED)
Novavax is working closely with government officials to develop and test a VLP vaccine against the novel influenza H1N1 virus. On April 24, 2009, the Centers for Disease Control and Prevention (CDC) in Atlanta, GA released the genetic sequence for the influenza A (H1N1) virus that killed a young child in California. Just four days later, Novavax received from the CDC the RNA from the influenza strain A/California/04/2009 (H1N1). Using this genetic material, Novavax scientists cloned the genes and programmed cultured cells to produce influenza H1N1 VLPs. In less than three weeks the company’s scientists produced prototype VLPs for preclinical testing from the H1N1 hemagglutinin (HA), neuraminidase (NA), and matrix 1 (M1) proteins and confirmed that they have the exact genetic sequence as the human H1N1 virus. The size and structure of the purified H1N1 VLPs are nearly identical to the novel influenza A (H1N1) flu virus but are not infectious because they lack the genetic information of influenza.
A critical step in the development of a novel H1N1 vaccine is the production of reagents necessary to measure the potency of the vaccine. Novavax has been able to produce the necessary reagents well ahead of schedule so that it can test for potency and release an H1N1 VLP vaccine candidate in 12 weeks or less.
Manufacturing (COMPLETED)
Production of influenza H1N1 VLPs was initiated in June 5, 2009 at our Rockville, MD manufacturing facility. The major unit operations include rapid expansion of cells, programming them to produce influenza VLPs separation of secreted virus-like particles from the cells, the purification of VLPs for use in the formulation of H1N1 vaccine.
from strain availability
- April 29, 2009 Receipt of influenza vaccine strain
(A/California/04/2009) RNA from CDC - May 04, 2009 Vaccine strain genes cloned
- May 14, 2009 Pilot-scale lot of A(H1N1) VLPs produced
- May 20, 2009 Influenza A(H1N1) VLPs produced for animal
studies - May 29, 2009 Recombinant seed for VLP production
- June 05, 2009 cGMP Manufacturing and testing of A(H1N1)
VLPs initiated - July 15, 2009 First cGMP lot of influenza A(H1N1) VLP
investigational vaccine completed
Human Testing (IN PROCESS)
Novavax is currently testing a range of vaccine doses and booster in human trials in Mexico. The number of doses of H1N1 vaccine to be used may vary according to age. A disproportionate number of children and young adults have been infected with this virus, suggesting that they may not have pre-existing immunity in contrast to older adults who may have some limited immunity to a swine-origin influenza A virus. As of March 2010, Novavax completed enrollment of its Pivotal H1N1 influenza trial in Mexico with over 4,550 subjects enrolled. This is the largest enrollment of a clinical trial in Novavax's history to date.