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 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
1 other identifier
interventional
150
1 country
4
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2024
CompletedStudy Start
First participant enrolled
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
March 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 21, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 27, 2026
CompletedMarch 9, 2026
March 1, 2026
1.1 years
March 6, 2024
March 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Solicited Adverse Events
frequency of solicited AEs (injection site and systemic reactions)
7 days after each vaccination
Solicited Adverse Events
severity of solicited AEs (injection site and systemic reactions)
7 days after each vaccination
Neutralizing antibodies against ZIKA virus (ZIKV)
Geometric mean titer (GMT) for neutralizing antibodies against (ZIKV) determined by virus neutralization assay
Day 57
Secondary Outcomes (21)
Solicited Adverse Events
7 days after any vaccination
Solicited Adverse Events
7 days after any vaccination
Unsolicited AEs
Day 395
Unsolicited AEs
Day 395
Vaccine-related unsolicited AEs
Day 395
- +16 more secondary outcomes
Study Arms (5)
VLA1601 Low dose
EXPERIMENTALVLA1601 Low dose + CpG 1018®
EXPERIMENTALVLA1601 Low dose + 3M-052-AF
EXPERIMENTALVLA1601 Medium dose
EXPERIMENTALVLA1601 High dose
EXPERIMENTALInterventions
CpG 1018® will be investigated in combination with VLA1601 Low dose
3M-052-AF will be investigated in combination with VLA1601 Low dose
0.45mL (milliliter), Day 1 and 29
Eligibility Criteria
You may qualify if:
- to 49 years of age
- BMI of ≥18.5 and \<30 kg/m2
- generally healthy as determined by the investigator's clinical judgement based on medical history, physical examination, and screening laboratory tests.
- If trial participant is of childbearing potential: negative pregnancy test; employ adequate birth control measures up to Day 208.
- Male participant agrees to employ adequate birth control measures up to 90 days after last vaccination.
You may not qualify if:
- Participant
- has a known history of the following flavivirus infection: Zika Virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV), Yellow Fever Virus (YFV), West-Nile Virus (WNV), or Tick-Borne Encephalitis Virus (TBEV).
- received or has plans to receive a licensed or investigational flavivirus vaccine during the course of the trial.
- travelled within 4 weeks prior to trial enrollment or has plans to travel to areas (including within the US) with Zika virus (ZIKV), Japanese Encephalitis Virus (JEV), Dengue Virus (DENV) or Yellow Fever Virus (YFV) active transmission/circulation during the course of the trial .
- received active or passive immunization within 4 weeks prior or planned to get such vaccination after any trial-vaccination.
- presents with clinically significant abnormal laboratory values, as determined by the investigator.
- tests positive for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
- has history of significant cardiovascular, respiratory (including asthma), metabolic, neurological (including Guillain-Barre syndrome \[GBS\]), psychiatric, hepatic, rheumatic, autoimmune, hematological, gastrointestinal, or renal disorder.
- with known or suspected defect of the immune system that would prevent an immune response to the vaccine.
- received immuno-suppressive therapy within 4 weeks prior to first vaccination. Radiation therapy or immunosuppressive cytotoxic drugs/ monoclonal antibodies in the previous 3 years.
- with a history of severe hypersensitivity reactions or anaphylaxis.
- with a history of any vaccine related contraindicating event .
- with acute febrile infections within two weeks prior to vaccination in this trial.
- donated blood within 4 weeks or received blood-derived products (e.g. plasma) within 12 weeks prior to vaccination in this trial or plans to donate blood or use blood products during the course of the trial.
- has a rash, dermatological condition or tattoos that would, in the opinion of the investigator, interfere with injection site reaction rating.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Flourish Research
Chicago, Illinois, 60640, United States
Velocity Clinical Research
Sioux City, Iowa, 51106, United States
Velocity Clinical Research
Lincoln, Nebraska, 68510, United States
Velocity Clinical Research
Omaha, Nebraska, 68134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2024
First Posted
March 28, 2024
Study Start
March 25, 2024
Primary Completion
April 21, 2025
Study Completion
February 27, 2026
Last Updated
March 9, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
After trial completion, Valneva may provide access to individual de-identified participant data and related trial documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Trial Report (CTR)) upon request from qualified researchers, and subject to Valneva's review and approval.