CSL Seqirus has been selected by a major US government agency to develop a vaccine candidate against a form of avian influenza.
The US Biomedical Advanced Research and Development Authority (BARDA), which is part of the US Department of Health and Human Services, selected the Australian company to deliver an H5N8 A/Astrakhan virus vaccine candidate for assessment in a Phase 2 clinical study that is anticipated to begin in 2023.
The past year has seen outbreaks of highly pathogenic avian influenza (HPAI) A(H5) viruses among wild and farmed birds, as well as commercial poultry, in North America, Africa, Asia and Europe.
BARDA has requested the manufacture and clinical assessment of the H5N8 vaccine candidate to support its pandemic preparedness program.
"Certain influenza strains such as avian flu present a serious pandemic risk, and governments, regulatory agencies, and vaccine manufacturers must take measures to ensure proper and rapid response," said Dr Jonathan Edelman, the vice president of vaccines clinical development and interim head of CSL R&D Seqirus Vaccines Innovation Unit.
"For influenza, this preparation begins with clinical trials to test that a vaccine candidate provides a sufficient level of immunogenicity against the strain of interest, and partnerships with governments guide our decision-making as we progress these candidates through the research and development phase."
Under the terms of the US$30.1 million agreement, CSL Seqirus will deliver an H5N8 A/Astrakhan virus vaccine candidate and will then sponsor a subsequent Phase 2 clinical trial to evaluate the candidate along with CSL Seqirus' proprietary adjuvant MF59.
CSL Seqirus MF59 has been successfully combined with other influenza strains in vaccines to boost immune response, as well as to accelerate manufacturing output.
The Phase 2 trial will assess the safety and immunogenicity of this vaccine. The study will also examine homologous and heterologous boosting after six months, as well as the use of heterologous priming pairs (H5N8 A/Astrakhan and H5N6 A/Guangdong.
"When faced with a public health threat like highly pathogenic avian influenza, governments make plans to protect the population, which takes both time and a substantial collaborative effort with industry," said Marc Lacey, the executive director of pandemic response solutions at CSL Seqirus. "For more than a decade, CSL Seqirus has demonstrated its ability to come to the aid of government partners to prepare for and rapidly respond to emerging pathogens of concern, and we are able and ready to do so again for avian influenza."