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Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults

Completed · Phase 1 · NCT06334393

Conditions: Zika, Zika Virus Infection

At a glance

Research payments reported, 2025
$2.0M
U.S. investigators named
4
Sites paid
2
Planned or actual enrollment
150

About the trial

Sponsor
Valneva Austria GmbH
Tested
VLA1601 (biological), CpG 1018® (biological), 3M-052-AF (biological)
Dates
Started 2024-03-25; completion 2026-02-27
Results posted
Not yet

This phase 1 clinical trial consists of an initial open-label sentinel run-in (n=25) and a randomized, double-blind, dose-finding (n=125) investigating three antigen dose levels (low, medium and high) of VLA1601 and bedside mixing of the low-dose formulation with one of the two additional adjuvants (CpG1018®, 3M-052-AF/AP 60-702). VLA1601 will be administered according to a two-dose regimen (i.e., on Day 1 and Day 29). The primary objective of this trial is to assess the safety and tolerability of the vaccine candidate up to 7 days after each vaccination; and to assess the immune response induced by the vaccine candidate 28 days after the second vaccination. Additionally, safety and immun…

From ClinicalTrials.gov, last updated 2026-03-09. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Valneva Austria GmbH reported $2.0M in research payments for this study in 2025 (1,017 payments).

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • Velocity Clinical Research-Sioux City $1.5M
  • Great Lakes Clinical Trials LLC $496,574

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.