TAK-426 Zika Vaccine
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, according to a recent study published by The Lancet. The vaccine was tested in a phase 1 study 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.
The peer-reviewed Journal of Infectious Diseases reported on December 9, 2022, on the two-year persistence of immune response to TAK-426 compared with that observed after natural infection. TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection. These phase 1 study results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations.
In February 2016, the World Health Organization (WHO) declared the Zika outbreak a Public Health Emergency of International Concern. On January 29, 2018, Takeda's Zika Vaccine candidate received U.S. FDA Fast Track Designation. On July 27, 2023, Takeda confirmed to support the expansion of our pipeline and the development of our programs, we have entered into partnerships with government organizations in Japan and the U.S. and leading global institutions.
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.
TAK-426 Vaccine Indication
The TAK-426 vaccine candidate prevents the Zika virus, which is caused by a virus transmitted by Aedes aegypti and Aedes albopictus mosquitoes. The Zika virus was first reported in continental South America in Brazil in May 2015. Zika virus is a flavivirus associated with 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.
TAK-426 Vaccine Dosage
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 Vaccine News
December 8, 2022 - Researchers wrote: In conclusion, we confirm that PIZV has an acceptable safety profile in healthy adults aged 18–49 years, with no vaccine-related SAEs through 2 years after vaccination. Two vaccinations elicited immune responses that persisted at high titers (GMTs >100) comparable to those observed in convalescent ZIKV-infected patients up to 2 years after vaccination in FV-naive and FV-primed adults. These safety and immunogenicity profiles of the high dose (10-µg) PIZV confirm its suitability for further clinical development.
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,hadh 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 worldwide. 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 Trials
The Journal of Infectious Diseases reported that a randomized, observer-blind, placebo-controlled, dose-selection, phase 1 trial was conducted in 18–49-year-old adults at nine centers (7 in the United States and 2 in Puerto Rico) from 13 November 2017 to 24 November 2020. The primary objectives were safety, tolerability, and immunogenicity of 3 increasing doses of TAK-426 administered as two doses 28 days apart to flavivirus (FV)–naive and FV-primed adults. Here, we report on the safety and persistence of immunity up to 2 years after primary vaccination with 10-μg TAK-426, the highest dose, and compare neutralizing antibody responses with those observed after natural infection. Results: TAK-426 at 10-μg had an acceptable safety profile in FV-naive and FV-primed adults up to 24 months after dose 2. Seropositivity for neutralizing antibodies was 100% at one year and 93.8% and 76.2% at two years in FV-naive and FV-primed groups, respectively. TAK-426 responses were comparable in magnitude and kinetics with those elicited by natural Zika virus infection.
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,hadh 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.
