One Zika Vaccine Clinical Trial Starts, While Another Stops
Takeda Zika virus purified, inactivated, alum-adjuvanted, whole vaccine candidate TAK-426 has progressed into a Phase 1 study
Does the dramatic decrease in new Zika virus cases during 2017 indicate that the threat has passed? Has the need for a preventive vaccine diminished?
Neither is true. When the Zika virus reactivates, not having a commercially available vaccine will be unfortunate.
In recent years, the Zika virus has had a devastating impact across more than 84 countries, territories and subnational areas, including the U.S.
Recently, two international pharmaceutical manufacturers announced some good and bad news.
The bad news is that Sanofi Pasteur announced that its funder had "de-scope" its contract for the development of an inactivated Zika vaccine.
But, the good news is that Takeda Pharmaceutical Company announced that its purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate (TAK-426) has progressed into a Phase 1 clinical trial.
This randomized, placebo-controlled, double-blind trial is designed to evaluate the safety and immunogenicity of the vaccine candidate, and will assess several dose levels to support the progression of TAK-426 into future studies.
The trial will take place approximately 15 months after Takeda Pharmaceutical received a contract and funding to develop a Zika vaccine from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA).
“BARDA remains committed to making available safe and effective Zika vaccines,” said Rick Bright, Ph.D., BARDA Director.
“Takeda’s Phase 1 clinical study is an important step toward this goal.”
Takeda’s Zika virus vaccine candidate (TAK-426) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine. The candidate is being developed as part of a broader effort to prevent the spread of the Zika virus in susceptible populations around the world.
Initial data from ZIK-101 are expected in 2018, and, if available Phase 1 data support it, Takeda will work toward initiating Phase 2 studies as soon as possible.
This clinical trial has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201600015C.
For more information, visit Takeda.
- SANOFI STATEMENT ON ZIKA VACCINE LICENSE
- Takeda to develop Zika Vaccine with up to $312 million in funding from US Government
- Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants
- Zika virus and complications: 2016 Public Health Emergency of International Concern
- CDC Emergency Operations Center moves to highest level of activation for Zika response
- IMMUNIZATION FACTS AND FIGURES April 2013
- Takeda Initiates Phase 1 Clinical Trial of Zika Vaccine Candidate