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Zika vaccine candidate enters human safety testing

NCT ID NCT06334393

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tested an inactivated Zika virus vaccine (VLA1601) in 150 healthy adults aged 18-49. Participants received two doses, and researchers monitored side effects and immune responses. The goal was to find the safest and most effective dose, including combinations with additional immune-boosting adjuvants.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
VLA1601 (inactivated Zika virus vaccine with adjuvants)
What this could lead to
If successful, this could lead to a safe and effective vaccine to prevent Zika virus infection, which can cause severe birth defects.
What could go wrong
This is an early Phase 1 trial with only 150 healthy adults, so results may not apply to the general population. The vaccine may not produce a strong enough immune response or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

150 people

The number who actually took part.

Started

Mar 2024

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 49 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * 18 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. Key Exclusion Criteria: 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. * presents with clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * is currently enrolled (ICF signed) or has participated in another clinical trial involving an investigational medicinal product (IMP) or device within 4 weeks prior to trial enrollment or is scheduled to participate in another clinical trial involving an IMP or investigational device during the course of this trial. * has a known or suspected problem with alcohol or drug abuse

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • 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

More trials for these conditions

Other studies related to the condition(s) this trial covers.