protocolSection identificationModule nctId: NCT06334393, orgStudyIdInfo id: VLA1601-102, briefTitle: Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-25, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-28, studyFirstPostDateStruct date: 2024-03-28, lastUpdatePostDateStruct date: 2024-03-28, sponsorCollaboratorsModule leadSponsor name: Valneva Austria GmbH, class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Zika, conditions: Zika Virus Infection, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: VLA1601, interventions name: CpG 1018®, interventions name: 3M-052-AF, outcomesModule primaryOutcomes measure: Solicited Adverse Events, primaryOutcomes measure: Solicited Adverse Events, primaryOutcomes measure: Neutralizing antibodies against ZIKA virus (ZIKV), secondaryOutcomes measure: Solicited Adverse Events, secondaryOutcomes measure: Solicited Adverse Events, secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: Unsolicited AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Any AEs, secondaryOutcomes measure: Any AEs, secondaryOutcomes measure: any vaccine-related AEs, secondaryOutcomes measure: Vaccine-related unsolicited AEs, secondaryOutcomes measure: Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Vaccine-related Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Vaccine-related Adverse Events of Special Interest (AESI), secondaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Serious Adverse Events (SAE), secondaryOutcomes measure: Vaccine-related Serious Adverse Events (SAE), secondaryOutcomes measure: Vaccine-related Serious Adverse Events (SAE), secondaryOutcomes measure: ZIKV-specific neutralizing antibodies, secondaryOutcomes measure: Seroconversion rate (SCR), secondaryOutcomes measure: Geometric Mean Fold Increase (GMFI), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 49 Years, stdAges: ADULT, contactsLocationsModule locations facility: Flourish Research, status: RECRUITING, city: Chicago, state: Illinois, zip: 60640, country: United States, contacts name: Rupal Trivedi, MD, role: CONTACT, geoPoint lat: 41.85003, lon: -87.65005, locations facility: Velocity Clinical Research, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68134, country: United States, contacts name: Frederick Raiser, MD, role: CONTACT, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False