Dataset Information

Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection.

ABSTRACT:

Background

We report 2-year persistence of immune response to Takeda's prophylactic purified formalin-inactivated whole Zika virus vaccine candidate (TAK-426) compared with that observed after natural infection.

Methods

A randomized, observer-blind, placebo-controlled, dose-selection, phase 1 trial was conducted in 18-49-year-old adults at 9 centers (7 in the United States, 2 in Puerto Rico) from 13 November 2017 to 24 November 2020. Primary objectives were safety, tolerability, and immunogenicity of 3 increasing doses of TAK-426 administered as 2 doses 28 days apart to flavivirus (FV)-naive and FV-primed adults. Here, we report on 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 1 year, and 93.8% and 76.2% at 2 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.

Conclusions

These results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations.

Clinical trials registration

NCT03343626.

SUBMITTER: Acosta CJ

PROVIDER: S-EPMC10226659 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature

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Publications

Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection.

Acosta Camilo J CJ Diaz Clemente C Nordio Francesco F Han Htay-Htay HH Moss Kelley J KJ Bohning Kelly K Kumar Pradeep P Liu Mengya M Patel Hetal H Pacciarini Filippo F Mwangi Vincent V Walter Elke E Powell Tim D TD El Sahly Hana M HM Baldwin Whitney R WR Santangelo Joseph J Anderson Evan J EJ Dubin Gary G

The Journal of infectious diseases 20230501 11

<h4>Background</h4>We report 2-year persistence of immune response to Takeda's prophylactic purified formalin-inactivated whole Zika virus vaccine candidate (TAK-426) compared with that observed after natural infection.<h4>Methods</h4>A randomized, observer-blind, placebo-controlled, dose-selection, phase 1 trial was conducted in 18-49-year-old adults at 9 centers (7 in the United States, 2 in Puerto Rico) from 13 November 2017 to 24 November 2020. Primary objectives were safety, tolerability, a ...[more]

PMID: 36484441

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Dataset Information

Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection.

Background

Methods

Results

Conclusions

Clinical trials registration

Publications

Persistence of Immunogenicity of a Purified Inactivated Zika Virus Vaccine Candidate in Healthy Adults: 2 Years of Follow-up Compared With Natural Infection.

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