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5,000 volunteers tracked to see if chikungunya vaccine is safe

NCT ID NCT07254702

Vaccine Sponsor: Valneva Austria GmbH Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 22, 2026 · Updated 4 times

Summary

This observational study will follow 5,000 people who received the VLA1553 chikungunya vaccine as part of a pilot vaccination program. Researchers will monitor for specific safety concerns like chikungunya-like reactions, heart problems, and arthritis over 60 days. The goal is to estimate how often these side effects occur and measure any increased risk linked to the vaccine.

What this could mean

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

Active substance
VLA1553 live-attenuated chikungunya vaccine
What this could lead to
If this study confirms the vaccine is safe, it could support wider use of VLA1553 to prevent chikungunya virus infection.
What could go wrong
This is an observational study, not a controlled trial, so it can't prove cause and effect. Rare side effects may still be missed even with 5,000 participants.
Why investors are watching

Valneva SE is running a large observational safety study of its VLA1553 vaccine candidate through its Austrian subsidiary, Valneva Austria GmbH. For a small-cap vaccine maker, a safety readout on 5,000 participants carries outsized weight because safety problems can halt a program or delay regulatory review. The result will tell investors whether the vaccine's risk profile stays clean at scale.

If it works: A clean safety result could support regulatory submissions and help Valneva move the vaccine toward market. That would strengthen the company's pipeline and its position as a vaccine developer.

If it fails: A safety signal or slow enrollment could delay the program and raise questions about the vaccine's viability. Trials fail or stall often, so a negative outcome would pressure Valneva's prospects.

AI-written from the trial record. Speculative, and not investment advice.

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.

Participants

About 5,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

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.

Who is studied

This study will collect data from approximately 5,000 individuals who received VLA1553, as per label, as part of the pilot vaccination strategy in selected municipalities in Brazil.

Ages

18 years and older

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.

Inclusion Criteria: 1. Male or female participants who received a single dose of VLA1553 at a vaccination unit while participating in the pilot vaccination strategy. 2. Individuals that are target for the pilot vaccination strategy at the time of vaccination. 3. Individuals understanding and being able to comply with all scheduled follow-up calls/contacts and study procedures. 4. Have given informed consent/assent prior to entering the study. Exclusion Criteria: 1. Individuals who have received investigational products within the 30 days prior to VLA1553 vaccination, or individuals who have received VLA1553/IXCHIQ previously or any authorized or approved CHIKV vaccine. 2. Individuals who are not expected to remain available for the study follow-up for the next 24 weeks after vaccination. 3. Pregnant women: women exposed to VLA1553 anytime during their pregnancy or within 30 days preceding their last menstrual period will be invited to participate in a separate pregnancy surveillance study (study identifier VLA1553-403).

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Conditions

The condition(s) this trial relates to.

chikungunya prevention target

As listed by the trial registrant

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

Chikungunya virus infection

Contacts and locations

Locations

  • Centro de Pesquisas Clínicas Universidade Federal Sergipe, Hospital e Maternidade São João de Deus

    Laranjeiras, Sergipe, 49060-025, Brazil

  • Fundação Faculdade Regional De Medicina De São José Do Rio Preto

    São Pedro, São Paulo, 15090-000, Brazil

  • Universidade Federal de Minas Gerais, CT Terapias Avançadas e Inovadoras

    Belo Horizonte, Minas Gerais, 31270-901, Brazil

More trials for these conditions

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