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First received: March 06, 2024

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

Study Status: COMPLETED

Recruit Status: COMPLETED

Condition: Zika

Study Type: INTERVENTIONAL


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

Brief 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…

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