Evidence map›Paper›PMID 36484441›Full record

Trial reportThe Journal of infectious diseases2023

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

Camilo J Acosta, Clemente Diaz, Francesco Nordio, Htay-Htay Han, Kelley J Moss, Kelly Bohning, Pradeep Kumar, Mengya Liu, Hetal Patel, Filippo Pacciarini and 8 more

Erratum issued Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase I
In one paragraph

Trial report in The Journal of infectious diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03343626 (A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
2.6field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03343626 phase1completednot on this map

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Safety, Immunogenicity, and Dose Ranging Study of Purified Inactivated Zika Virus Vaccine (PIZV) Candidate in Flavivirus Naïve and Primed Healthy Adults Aged 18 to 49 Years

TypeinterventionalSponsorTakedaRan2017 to 2020Enrolled271ConditionsVirus, Zika, Zika Virus Disease, Flavivirus Infections, Healthy ParticipantsArmsPlacebo, PIZV
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  5. An updated review of Zika virus vaccine development.Clinical and experimental vaccine research · 2025
    Review
  6. Article
  7. Review
  8. Zika virus: an overview update.Current opinion in HIV and AIDS · 2025
    Review
  9. Article
  10. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 5 institutions in 3 countries.

Camilo J AcostaTakeda Vaccines, Cambridge, Massachusetts, USA.
Clemente DiazPuerto Rico Clinical and Translational Research Consortium, San Juan, Puerto Rico.
Francesco NordioTakeda Vaccines, Cambridge, Massachusetts, USA.
Htay-Htay HanTakeda Vaccines, Cambridge, Massachusetts, USA.
Kelley J MossTakeda Vaccines, Cambridge, Massachusetts, USA.
Kelly BohningTakeda Vaccines, Cambridge, Massachusetts, USA.
Pradeep KumarTakeda Pharmaceuticals International, Zürich, Switzerland.
Mengya LiuTakeda Vaccines, Cambridge, Massachusetts, USA.
Hetal PatelTakeda Vaccines, Cambridge, Massachusetts, USA.
Filippo PacciariniTakeda Vaccines, Cambridge, Massachusetts, USA.
Vincent MwangiTakeda Vaccines, Cambridge, Massachusetts, USA.
Elke WalterTakeda Pharmaceuticals International, Zürich, Switzerland.
Tim D PowellTakeda Vaccines, Cambridge, Massachusetts, USA.
Hana M El SahlyBaylor College of Medicine, Houston, Texas, USA.
Whitney R BaldwinTakeda Vaccines, Cambridge, Massachusetts, USA.
Joseph SantangeloTakeda Vaccines, Cambridge, Massachusetts, USA.
Evan J AndersonEmory University School of Medicine, Atlanta, Georgia, USA.ORCID 0000-0002-1576-4420
Gary DubinTakeda Pharmaceuticals International, Zürich, Switzerland.
Takeda (United States) · USTakeda (Switzerland) · CHBaylor College of Medicine · USClinical Research Puerto Rico · PREmory University · US

Funding

ASPR HHSHHSNIAID NIH HHS HHSN272200800005CNIH HHS HHSN272200800005C
6 · The paper itself

Abstract

backgroundWe 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.

methodsA 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.

resultsTAK-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.

conclusionsThese results support the further clinical development of TAK-426 for both FV-naive and FV-primed populations. CLINICAL TRIALS REGISTRATION: NCT03343626.

Indexed as

Zika VirusZika Virus InfectionAdolescentAdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFollow-Up StudiesHumansImmunogenicity, VaccineMiddle AgedVaccines, InactivatedYoung AdultAntibodies, NeutralizingAntibodies, ViralVaccines, Inactivatednatural infectionneutralizing antibody responsepersistencesafetyvaccineZika virus

Identifiers

PMID36484441
PMCPMC10226659
OpenAlexW4310964605

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.