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Evaluation of IXCHIQ® Vaccine Immunogenicity

ConditionsHealthy AdultHealthy Adolescents
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age12-59
SponsorMauro Martins Teixeira

About this trial

The goal of this clinical trial is to evaluate the quality and duration of the immune response against chikungunya virus elicited by the IXCHIQ® vaccine in healthy adults and adolescents. The main questions it aims to answer are:

Is the cellular immune response elicited by IXCHIQ® adequate for Chikungunya prevention? Is the IXCHIQ® vaccine safe? How does the immune response elicited by IXCHIQ® behave at the different time points evaluated?

Participants will:

Receive the IXCHIQ® vaccine; Be evaluated by medical personnel and have a blood sample taken on days 3, 7, 30, 180, and 720 after vaccination; Be contacted by phone 60 days after vaccination.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

The participant or guardian understands the procedures and requirements, and is willing and able to provide informed consent for full participation in the study;

Individuals of both sexes aged 12 to 59 years.

Disqualifiers

Participants under 12 years of age or 60 years of age or older;

Those with any contraindication identified in Ministry of Health Technical Note No. 9/2026-CGFAM/DPNI/SVSA/MS (https://www.gov.br/saude/pt-br/centrais-de-conteudo/publicacoes/notas-tecnicas/2026/nota-tecnica-no-9-2026-cgfam-dpni-svsa-ms.pdf - Technical Note: Guidelines for monitoring the safety of the Chikungunya vaccine used during the pilot vaccination strategy in Brazil - 2026);

Participants unavailable to attend the planned study visits;

Participants who do not agree to sign the Informed Consent Form (ICF);

Trial design

Design model

Single group

Treatments tested in this trial

  • IXCHIQ vaccine

    Biological/Vaccine

    Live-attenuated monovalent vaccine against Chikungunya virus - IXCHIQ

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: IXCHIQ vaccineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Celular immunogenicity

Number and percentage of the various vaccine-induced mononuclear and polymorphonuclear populations, as assessed by flow cytometry, comparing age groups.

Time frame
3 years

Secondary outcomes

1

Safety evaluation

To evaluate the incidence of adverse events, particularly adverse events of special interest (Chikungunya-like adverse events \[CLARs\], carditis, encephalitis, and grade 3 or higher adverse events), up to 60 days after vaccination.

Time frame
60 days
2

Neutralizing antibodies duration

Titer of antibodies capable of neutralizing a Brazilian Chikungunya strain and the vaccine strain in a plaque neutralization assay.

Time frame
3 years
3

Immunological profile evaluation

Titer of antibodies capable of neutralizing a Brazilian Chikungunya strain and the vaccine strain in a plaque neutralization assay.

Time frame
3 years
4

Immunological crossover

Correlation matrix-in the form of correlograms or heatmaps-of the humoral and cellular response.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mauro Martins Teixeira

Lead sponsor

Federal University of Minas Gerais

Sponsor institution

FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: