Next Article in Journal
Synbiotics as Treatment for Irritable Bowel Syndrome: A Review
Next Article in Special Issue
Transcriptomic Signatures of Zika Virus Infection in Patients and a Cell Culture Model
Previous Article in Journal
Characteristics of the Perianthic Endophytic Fungal Communities of the Rare Horticultural Plant Lirianthe delavayi and Their Changes under Artificial Cultivation
Previous Article in Special Issue
Predicting Efficacy of a Purified Inactivated Zika Virus Vaccine in Flavivirus-Naïve Humans Using an Immunological Correlate of Protection in Non-Human Primates
 
 
Search for Articles:
Title / Keyword
Author / Affiliation / Email
Journal
Article Type
 
 
Advanced Search
 
Section
Special Issue
Volume
Issue
Number
Page
 
Journals
Microorganisms
Volume 12
Issue 7
10.3390/microorganisms12071492
microorganisms-logo
Submit to this Journal Review for this Journal Propose a Special Issue
► Article Menu

Article Menu

share Share announcement Help format_quote Cite question_answer Discuss in SciProfiles
first_page
settings
Order Article Reprints
Font Type:
Arial Georgia Verdana
Font Size:
Aa Aa Aa
Line Spacing:
Column Width:
Background:
Article

Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV)

by
Camilo J. Acosta
1,*,
Francesco Nordio
1,
Eloi Kpamegan
1,
Kelley J. Moss
1,
Pradeep Kumar
2 and
Kazuhiro Hirata
3
1
Takeda Vaccines Inc., Cambridge, MA 02139, USA
2
Takeda Pharmaceuticals International AG, 8152 Zürich, Switzerland
3
Takeda Pharmaceutical Company Limited, Osaka 541-0045, Japan
*
Author to whom correspondence should be addressed.
Microorganisms 2024, 12(7), 1492; https://doi.org/10.3390/microorganisms12071492
Submission received: 24 June 2024 / Revised: 16 July 2024 / Accepted: 17 July 2024 / Published: 21 July 2024
(This article belongs to the Special Issue Zika Virus Infection and Immune Response)
Browse Figures
Versions Notes

Abstract

We previously reported the first-in-human assessment of three doses (2, 5, and 10 µg) of purified inactivated Zika virus vaccine (PIZV or TAK-426) in the Phase 1 ZIK-101 study (NCT03343626). Here, we report dose selection based on extended safety and immunogenicity data (6 months post-vaccination) and discuss considerations (e.g., immunological, historic, flavivirus immunological cross-reactions) for selecting a Zika virus (ZIKV) vaccine dose formulation. TAK-426 dose selection was conducted at the first interim analysis, and was based on cumulative safety data from both flavivirus-naïve (up to ≥28 days post-dose PD2) and flavivirus-primed participants (up to ≥28 days PD1), and on immunogenicity data from flavivirus-naïve participants only (at 28 days PD1 and 28 days PD2). The safety profile from TAK-426 recipients was compared to placebo recipients. Immunogenicity was assessed by geometric mean titer ratios of neutralizing anti-ZIKV antibodies and differences in seroconversion rates. 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.
Keywords: PIZV; TAK-426; Zika virus; purified inactivated Zika vaccine; dose selection; safety; neutralizing antibody response; cross-reactive immunity; vaccine PIZV; TAK-426; Zika virus; purified inactivated Zika vaccine; dose selection; safety; neutralizing antibody response; cross-reactive immunity; vaccine

Share and Cite

MDPI and ACS Style

Acosta, C.J.; Nordio, F.; Kpamegan, E.; Moss, K.J.; Kumar, P.; Hirata, K. Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV). Microorganisms 2024, 12, 1492. https://doi.org/10.3390/microorganisms12071492

AMA Style

Acosta CJ, Nordio F, Kpamegan E, Moss KJ, Kumar P, Hirata K. Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV). Microorganisms. 2024; 12(7):1492. https://doi.org/10.3390/microorganisms12071492

Chicago/Turabian Style

Acosta, Camilo J., Francesco Nordio, Eloi Kpamegan, Kelley J. Moss, Pradeep Kumar, and Kazuhiro Hirata. 2024. "Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV)" Microorganisms 12, no. 7: 1492. https://doi.org/10.3390/microorganisms12071492

APA Style

Acosta, C. J., Nordio, F., Kpamegan, E., Moss, K. J., Kumar, P., & Hirata, K. (2024). Immunological and Safety Considerations When Selecting the Dose Formulation of a Purified Inactivated Zika Virus Vaccine (PIZV). Microorganisms, 12(7), 1492. https://doi.org/10.3390/microorganisms12071492

Note that from the first issue of 2016, this journal uses article numbers instead of page numbers. See further details here.

Article Metrics

Back to TopTop