Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults
Public ClinicalTrials.gov record NCT06334393. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Double-blind, Randomized, Dose Finding Clinical Trial With an Open-label run-in Part to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Flavivirus-naïve Adults Aged 18 to 49 Years
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06334393
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 49 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 24, 2024
- Primary completion
- Apr 20, 2025
- Completion
- Feb 26, 2026
- Last update posted
- Mar 8, 2026
2024 – 2026
United States locations
- U.S. sites
- 4
- U.S. states
- 3
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Flourish Research | Chicago | Illinois | 60640 | — |
| Velocity Clinical Research | Sioux City | Iowa | 51106 | — |
| Velocity Clinical Research | Lincoln | Nebraska | 68510 | — |
| Velocity Clinical Research | Omaha | Nebraska | 68134 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06334393, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 8, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06334393 live on ClinicalTrials.gov.