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

Conditions studied: Zika, Zika Virus Infection

In brief

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.

Key facts

Study ID
NCT06334393
Run by
Valneva Austria GmbH
People needed
150
Starts
2024-03-25
Expected to finish
2026-02-27
Last updated by the study team
2026-03-09

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

Where it is running

Full record on ClinicalTrials.gov

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