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COMPLETED Phase 1

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

NCT06334393 · View on ClinicalTrials.gov ↗

Study Summary

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 immune response of the vaccine candidate will be monitored throughout the trial.

Interventions

  • BIOLOGICAL VLA1601
  • BIOLOGICAL CpG 1018®
  • BIOLOGICAL 3M-052-AF

Study Locations (4)

Nebraska

  • Velocity Clinical Research — Lincoln
  • Velocity Clinical Research — Omaha

Illinois

  • Flourish Research — Chicago

Iowa

  • Velocity Clinical Research — Sioux City

Trial Details

FieldValue
Enrollment Target 150 participants
Start Date 2024-03-25
Est. Completion 2026-02-27
Phase Phase 1

Sponsor

Valneva Austria

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06334393

The ClinicalTrials.gov registry entry for NCT06334393 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Valneva Austria, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Zika appearing as the primary indexed condition, and to 3 interventions — of which VLA1601 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06334393 reports 4 study locations spanning 3 distinct geographic areas — top geographies include Nebraska, Illinois, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06334393 about?

NCT06334393 is a clinical study titled "Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults". 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 ...

What is the current status of trial NCT06334393?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 150 participants. The study started on 2024-03-25. Estimated completion is 2026-02-27.

What conditions does trial NCT06334393 study?

This clinical trial studies the following conditions: Zika, Zika Virus Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06334393?

The interventions under investigation include: VLA1601 (BIOLOGICAL), CpG 1018® (BIOLOGICAL), 3M-052-AF (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06334393?

This trial is sponsored by Valneva Austria, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06334393 being conducted?

This trial has 4 study locations across Illinois, Iowa, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial