TAK-426 / Takeda - LARVOL DELTA

Zika Virus Neutralizing Antibody Responses Elicited by Vaccination or Infection. (PubMed, Open Forum Infect Dis) - "The kinetics of ZIKV nAbs were similar for both the natural infection and vaccination groups, exhibiting a peak, decline, and stabilization pattern; however, vaccine non-inferiority was not demonstrated. Our findings suggest that nAbs evoked by the current phase 1 formulation and dosage of TAK-426 may not protect against a ZIKV infection in endemic countries and that a booster dose should be further evaluated."

Journal • Infectious Disease

Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV). (PubMed, Microorganisms) - P1 | "There was no significant difference in safety between the three TAK-426 doses. The 10 μg dose provided the earliest and strongest immune response (with close to 100% seroconversion and higher antibody titers PD1 in flavivirus-naïve participants), and was well tolerated with acceptable safety profiles in both flavivirus-naïve and flavivirus-primed participants; this dose was selected for further development."

Journal • Infectious Disease

Predicting Efficacy of a Purified Inactivated Zika Virus Vaccine in Flavivirus-Naïve Humans Using an Immunological Correlate of Protection in Non-Human Primates. (PubMed, Microorganisms) - "The predicted probability of protection of TAK-426 against ZIKV infection was determined using the two-parameter LR model that fit the calculated VE in rhesus macaques and the flavivirus-naïve phase 1 trial participants' ZIKV NAb GMTs log10 EC50, measured by a ZIKV reporter virus particle assay, at 1 month post dose 2. The TAK-426 10 µg dose predicted a probability of protection from infection of 98% among flavivirus-naïve phase 1 trial participants."

Journal • Infectious Disease

A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Takeda | N=78 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Infectious Disease

A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults (clinicaltrials.gov) - P2 | N=78 | Not yet recruiting | Sponsor: Takeda | N=156 ➔ 78 | Trial completion date: Nov 2024 ➔ Jul 2024 | Initiation date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Nov 2024 ➔ Jul 2024

Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease

Impact of prior flavivirus vaccination on immunogenicity and efficacy of an inactivated Zika vaccine in Indian rhesus macaques. (PubMed, Vaccine) - "However, all macaques were protected against viremia after Zika virus challenge 8-12 months post-PIZV vaccination. Therefore, vaccine-induced immunity against heterologous flavivirus vaccines does not impact PIZV efficacy in macaques."

Journal • Infectious Disease

Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-Up Compared With Natural Infection. (PubMed, J Infect Dis) - P1 | "These results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations."

Journal • Infectious Disease

A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Takeda | Initiation date: Dec 2022 ➔ Jun 2023

Trial initiation date • Infectious Disease

A Study of Purified Inactivated Zika Virus Vaccine (PIZV) in Healthy Adults (clinicaltrials.gov) - P2 | N=156 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Infectious Disease

Safety and immunogenicity of a purified inactivated Zika virus vaccine candidate in healthy adults: an observer-blind, randomised, phase 1 trial. (PubMed, Lancet Infect Dis) - P1 | "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."

Clinical • Journal • P1 data • Infectious Disease

Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants (clinicaltrials.gov) - P1; N=271; Completed; Sponsor: Takeda; Active, not recruiting ➔ Completed

Clinical • Trial completion • Infectious Disease

Safety, Immunogenicity and Dose Ranging Study of Inactivated Zika Virus Vaccine in Healthy Adult Participants (clinicaltrials.gov) - P1; N=271; Active, not recruiting; Sponsor: Takeda; Recruiting ➔ Active, not recruiting; Trial completion date: Feb 2021 ➔ Nov 2020; Trial primary completion date: Nov 2020 ➔ Dec 2018

Clinical • Enrollment closed • Trial completion date • Trial primary completion date