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Chikungunya vaccine safety checked in pregnant women

NCT ID NCT07414524

Knowledge-focused 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study follows 200 pregnant women in Brazil who received the chikungunya vaccine (VLA1553) during pregnancy or shortly before. Researchers will track pregnancy and infant health up to 12 weeks after birth, comparing them to a similar group of women who got routine vaccines. The goal is to see if the vaccine is safe for both mother and baby.

What this could mean

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

Active substance
Live-attenuated chikungunya virus vaccine (VLA1553)
What this could lead to
If successful, this study could provide important safety data on the chikungunya vaccine for pregnant women, helping guide vaccination recommendations.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. The study is small (200 participants) and only looks at short-term outcomes.

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 200 people

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

Started

Jun 2026

Expected to finish

Dec 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

The control group will consist of women who have received vaccine(s) approved for use during pregnancy by the MoH and who meet the matching criteria.

Ages

18 years and older

Sex

Female participants only

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: VLA1553 vaccinated population: * Women who have received the single dose of the VLA1553 vaccine during pregnancy or within the 30 days prior to the first day of the last menstrual period. * Pregnant at the time of enrolment in the study. * The participant understands and agrees to comply with the study procedures. Control group: * Pregnant at the time of enrolment in the study. * Women who have received vaccine(s) approved for use during pregnancy by the MoH and who meet the matching criteria described in the protocol. * The participant understands and agrees to comply with the study procedures. * Women who have not received the VLA1553 vaccine during pregnancy or within the 30 days prior to the first day of the last menstrual period. Exclusion Criteria: * Women who do not provide informed consent. * Women who are not part of the target population of the pilot vaccination strategy at the time of vaccination.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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

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