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Cancer Vaccine

VLA1601 Medium dose for Zika Virus

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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 395 (including day 1, 15, 29, 43, 208)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Neutralizing antibodies against ZIKA virus (ZIKV)

Secondary outcome measures

Adverse Events of Special Interest (AESI)

Any AEs

Geometric Mean Fold Increase (GMFI)

+9 more

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

Do I qualify?Apply below to find out

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

54,769 Total Patients Enrolled

1 Trials studying Zika Virus

67 Patients Enrolled for Zika Virus

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do individuals younger than 65 years qualify for participation in this study?

"As outlined in the eligibility criteria for this investigation, potential participants must be at least 18 years old and no older than 49."

Answered by AI

What is the current number of individuals actively involved in this medical study?

"Indeed, the information available on clinicaltrials.gov shows that recruitment for this clinical trial is in progress. The trial was initially posted on March 25th, 2024 and last modified on March 26th, 2024. The research team aims to enroll a total of 150 individuals from two distinct sites."

Answered by AI

Are there any ongoing opportunities for patients to enroll in this clinical trial?

"Indeed, the details on clinicaltrials.gov affirm that recruitment for this trial is ongoing. The trial was initially posted on March 25th, 2024 and last updated on March 26th, 2024. Enrollment of around 150 participants will take place across two designated sites."

Answered by AI

Has the medium dosage of VLA1601 received approval from the FDA?

"Based on our team's assessment at Power, the safety ranking for VLA1601 Medium dose is marked as 1 due to its Phase 1 trial status where there exists only a limited amount of data supporting both efficacy and safety."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Phase 1 Trial to Assess the Safety and Immunogenicity of an Inactivated, Adjuvanted Whole Zika Virus Vaccine Candidate (VLA1601) in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06334393.

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