Zika vaccine candidate enters human safety testing
NCT ID NCT06334393
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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150 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Feb 2026
- Lead sponsor
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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
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18 to 49 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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Flourish Research
Chicago, Illinois, 60640, United States
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Velocity Clinical Research
Sioux City, Iowa, 51106, United States
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Velocity Clinical Research
Lincoln, Nebraska, 68510, United States
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Velocity Clinical Research
Omaha, Nebraska, 68134, United States
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