TAK-426 (PIZV) Zika Vaccine Description 2022
Takeda's TAK-426 (PIZV) is a purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate. The absence of specific treatment makes a prophylactic Zika virus vaccine an unmet medical need, stated a recent study published by The Lancet.
The vaccine was tested in a phase 1 study and is called PIZV or TAK-426 adjuvanted with aluminum hydroxide. TAK-426 was found well tolerated, with an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults.
On January 29, 2018, Takeda’s Zika Vaccine candidate received U.S. FDA Fast Track Designation.
Osaka, Japan-based Takeda is a patient-focused, values-based, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future to people worldwide.
The TAK-426 vaccine candidate prevents the Zika virus. Zika is caused by a virus transmitted primarily by Aedes aegypti mosquitoes. The Zika virus was first reported in continental South America in Brazil in May 2015. Zika virus is a flavivirus transmitted by Aedes aegypti and Aedes albopictus mosquitoes and is associated with cases of congenital malformations and neurological complications.
According to the World Health Organization (WHO), symptoms of Zika may include mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise, or headache. In February 2016, WHO declared the Zika outbreak to be a Public Health Emergency of International Concern.
In a phase 1 study, TAK-426 was administered by intramuscular injection into the middle third of the deltoid muscle, preferably in the non-dominant arm on Days 1 (Visit 1) and 29 (Visit 4). Three different vaccine doses containing different protein concentrations (2, 5, or 10 micrograms [mcg]) will be given as a two-dose schedule to flavivirus naive and primed healthy adults. Based on a recent study, the 10 μg TAK-426 dose was selected for further clinical development.
TAK-426 News 2016 - 2022
November 19, 2021 - The company presented: Measurement Of Zika Virus-Specific Antibodies Using A Microsphere-Based Competitive Immunoassay. 'Collectively, our data suggest that the assay can differentiate ZIKV-specific antibodies from antibodies to other FVs elicited by natural infection or vaccination. Availability of a ZIKV-specific antibody-based immunoassay will improve differential diagnosis, serosurveillance, and support development and implementation of ZIKV vaccines in FV endemic regions.'
May 18, 2021 - Study Interpretation: TAK-426 was well tolerated, with an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on the safety and immunogenicity profiles of all TAK-426 doses assessed, the 10 μg TAK-426 dose was selected for further clinical development. Study Funding: Takeda Vaccines and the US Biomedical Advanced Research and Development Authority.
August 26, 2019 – A recent Zika study focused on eliminating the mosquito and sexual transmission of the Zika virus with a preventive vaccine.
January 29, 2018 - Takeda Pharmaceutical Company Limited announced that the U.S. FDA had granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.
September 2, 2016 - Takeda announced that BARDA, the Biomedical Advanced Research and Development Authority, has selected Takeda’s Vaccine Business Unit to develop a vaccine to support the Zika response in the US and affected regions around the world. Initial funding from BARDA, which is a division of the Office of the Assistant Secretary for Preparedness and Response within the US Department of Health and Human Services, is for $19.8 million to cover the vaccine development through Phase 1, with potential funding of up to $312 million if all options to take the vaccine through Phase 3 trials and filing of the Biologics License Application in the USA.
TAK-426 Clinical Trial
Clinical Trial NCT03343626: Safety, Immunogenicity, and Dose-Ranging Study of Inactivated Zika Virus Vaccine in 271 Healthy Adult Participants. This multi-center trial will be conducted in the United States and Puerto Rico. The overall time to participate in this study is up to 25 months. Participants will make multiple visits to the clinic on Days 1, 8, 29, 36, 57, 211, 393. In addition, they will be contacted by telephone on Day 133 (Visit 7) and Day 575 (Visit 9) and also visit the clinic on Day 757 (Visit 11), depending on the study arm, for a final follow-up assessment. If initial data from ZIK-101 are supportive, Takeda will work to progress into Phase 2 development as soon as possible.
On September 21, 2021, The Lancet reported the findings of this clinical trial. Between Nov 13, 2017, and Oct 24, 2018, 894 volunteers were screened and 271 enrolled (125 flavivirus-naive and 146 flavivirus-primed participants). All TAK-426 doses were well tolerated with no deaths, no vaccine-related serious adverse events, and similar rates of mainly mild to moderate adverse events. Interpretation: The researchers concluded that TAK-426 was well tolerated, with an acceptable safety profile, and was immunogenic in both flavivirus-naive and flavivirus-primed adults. Based on these results TAK-426 will continue to be tested in clinical settings.