Even after the Biomedical Advanced Research and Development Authority suspended funding to its Sanofi-partnered Zika vaccine project, the agency continued its financial commitment to Takeda’s project. Now, Takeda has advanced its candidate into human testing.
The purified, inactivated, alum-adjuvanted vaccine, dubbed TAK-426, contains whole Zika virus. For the phase 1 trial, Takeda aims to enroll 240 flavivirus-naïve healthy adult subjects in Florida, Kansas, New York State and Puerto Rico. No pregnant women will be admitted into the study, according to information posted on clinicaltrials.gov.
Investigators plan to examine the safety and immunogenicity of the vaccine at three different doses, given as a two-dose regimen 28 days apart. The team will follow the subjects for up to a year.
Back in September 2016, BARDA committed $19.8 million for Takeda to cover the vaccine development through phase 1 and pledged up to $312 million in total to help it through late-stage testing and FDA review. About two months after that, though, the WHO removed Zika’s “emergency” designation but said the virus remains a significant enduring public health challenge.
More recently, Sanofi Pasteur in September ended its development and licensing deal with the Walter Reed Army Institute of Research for another candidate after intense public debate over future pricing and a “profound reduction in the number of new Zika cases,” according to the French vaccine maker. Still, several other companies and institutions are forging ahead.
Inovio’s DNA vaccine was the first to enter human studies, and NIH’s candidate started a phase 2/2b trial in late March. Themis advanced its live attenuated recombinant Zika shot into phase 1 in April, while Moderna also has BARDA grant for its mRNA shot currently in a phase 1/2 trial. GeoVax’s modified vaccinia virus Ankara-based candidate returned positive preclinical data, as well.