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Cancer Vaccine

Vaccine for Zika

Phase 1
Recruiting
Research Sponsored by Valneva Austria GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 395 (including day 1, 15, 29, 43, 208)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new vaccine called VLA1601 to see if it is safe and effective. The trial will involve 150 participants and will test three different doses of the vaccine. The participants

Who is the study for?
This trial is for healthy adults who can participate in a study testing a new Zika virus vaccine. Participants will receive two doses of the vaccine, with some getting additional ingredients to boost their immune response.
What is being tested?
The trial is examining three different dose levels of VLA1601, a Zika virus vaccine candidate, mixed with adjuvants CpG1018® or 3M-052-AF/AP 60-702. The goal is to find the safest and most effective dose for inducing an immune response.
What are the potential side effects?
Potential side effects are being closely monitored but may include typical reactions to vaccines such as soreness at injection site, fever, fatigue, headache and possibly allergic reactions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 395 (including day 1, 15, 29, 43, 208)
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 395 (including day 1, 15, 29, 43, 208) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neutralizing antibodies against ZIKA virus (ZIKV)
Secondary study objectives
Adverse Events of Special Interest (AESI)
Any AEs
Geometric Mean Fold Increase (GMFI)
+9 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: VLA1601 Medium doseExperimental Treatment1 Intervention
Group II: VLA1601 Low dose + CpG 1018®Experimental Treatment2 Interventions
Group III: VLA1601 Low dose + 3M-052-AFExperimental Treatment2 Interventions
Group IV: VLA1601 Low doseExperimental Treatment1 Intervention
Group V: VLA1601 High doseExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VLA1601
2018
Completed Phase 1
~70

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Valneva Austria GmbHLead Sponsor
45 Previous Clinical Trials
59,009 Total Patients Enrolled
1 Trials studying Zika Virus Infection
67 Patients Enrolled for Zika Virus Infection
~17 spots leftby Dec 2024
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