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NCT06334393 · ClinicalTrials.gov registry record · Phase 1
Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults
A Phase 1 study of Zika and Zika Virus Infection, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 1
- Development phase
- 150
- Enrollment target
- 4
- Study locations
NCT06334393 is a Phase 1 study of Zika and Zika Virus Infection that has completed, run by Valneva Austria. The registered enrollment target is 150 participants, below the 1,710-participant average among 3 other Zika trials with a reported enrollment target (91% lower). The trial reports 4 study locations across 3 states.
The verdict
NCT06334393, a Phase 1 study of Zika and Zika Virus Infection, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 150 participants
- Enrollment target
- 4
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2024-03-25 |
| Est. Completion | 2026-02-27 |
| Phase | Phase 1 |
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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, categorized as Phase 1. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,710-participant average among 3 other Zika trials with a reported enrollment target (91% lower). The listed sponsor is Valneva Austria, which has 11 total studies on file at ClinicalTrials.gov.
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.
NCT06334393 reports 4 study locations spanning 3 distinct geographic areas - top geographies include Nebraska, Illinois, Iowa.
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.
What interventions are being tested in trial NCT06334393?
The interventions under investigation include: VLA1601 (BIOLOGICAL), CpG 1018® (BIOLOGICAL), 3M-052-AF (BIOLOGICAL).
Who is sponsoring clinical trial NCT06334393?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
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.
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