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Healthy AdultPhase 2IMUNO-CHIQNCT07846293

Evaluation of IXCHIQ® Vaccine Immunogenicity

A Phase 2 study testing IXCHIQ vaccine in people with Healthy Adult and Healthy Adolescents, run by Mauro Martins Teixeira at 1 site in Brazil.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 59 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adult, Healthy Adolescents
What is being tested?
IXCHIQ vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteBrazil
Study dates
24 Sep 2026to Jul 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 59 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

  • 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);
  • Positive β-hCG test on the day of vaccination, for women of reproductive potential;
  • Participants who are pregnant or planning to become pregnant within the 3 months following the vaccine dose;
Show all 9Show fewer
  • Participants who are breastfeeding;
  • Participants with a known or suspected immune system defect that could influence the immune response to the vaccine, such as congenital or acquired immunodeficiency-including HIV infection, post-organ transplant status, or immunosuppressive therapy within 4 weeks prior to Visit 1. Immunosuppressive therapy is defined as the chronic administration of prednisone (more than 14 days) or an equivalent at a dosage of ≥2 mg/kg/day during the 4 weeks prior to study entry. Note: radiotherapy or cytotoxic immunosuppressive drugs/monoclonal antibodies within the previous 3 years; topical and inhaled steroids are permitted.
  • Any clinical instability identified by the attending physician that could place the participant at risk.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pedro R J Almeida, MD, MSc contact

+55 31 995166160

pedrojesus@ufmg.br

Brazil1 site

  • Clinical Research Unit

    Belo Horizonte, Minas Gerais, 30750140

Other trials in Brazil

About this study

Official title: Evaluation of Immunogenicity and Duration of Immunity of the IXCHIQ® Vaccine Against CHIKV

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.

Being tested
IXCHIQ vaccine
Keywords
IXCHIQ, Chikungunya, Immunogenicity
Medical subject headings
Chikungunya Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IXCHIQ vaccineBiological

    Live-attenuated monovalent vaccine against Chikungunya virus - IXCHIQ

Study groups in NCT07846293
Study groupRoleWhat they receive
IXCHIQ vaccineExperimentalIXCHIQ vaccine
Receives: Biological: IXCHIQ vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Celular immunogenicity

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

    Measured: 3 years

Secondary outcomes (4)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 3 years

  4. Immunological crossover

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

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2026
  2. Study start24 Sep 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07846293
Sponsor's protocol ID
IMUNO-CHIQ
Other IDs
APQ-03199-26
Acronym
IMUNO-CHIQ
Status last verified
Sep 2026
First submitted
22 Sep 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication may be shared uppon reasonable request to central contact person and/or paper correspondent.

Publications

  • Weisova P, Scheiblauer S, Ecker J, Schneider M, Hochreiter R, Bitzer A, Kosulin K, Schoengrundner P, Fuchs U, Rodeles L, Mazara S, Donastorg Y, Rivera S, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. Live-attenuated chikungunya vaccine in children: a randomized phase 2 trial. Nat Med. 2026 Feb;32(2):561-571. doi: 10.1038/s41591-025-04197-2. Epub 2026 Feb 6.

    PubMed 41652122

  • Thiberville SD, Moyen N, Dupuis-Maguiraga L, Nougairede A, Gould EA, Roques P, de Lamballerie X. Chikungunya fever: epidemiology, clinical syndrome, pathogenesis and therapy. Antiviral Res. 2013 Sep;99(3):345-70. doi: 10.1016/j.antiviral.2013.06.009. Epub 2013 Jun 28.

    PubMed 23811281

  • Simon F, Javelle E, Cabie A, Bouquillard E, Troisgros O, Gentile G, Leparc-Goffart I, Hoen B, Gandjbakhch F, Rene-Corail P, Franco JM, Caumes E, Combe B, Poiraudeau S, Gane-Troplent F, Djossou F, Schaerverbeke T, Criquet-Hayot A, Carrere P, Malvy D, Gaillard P, Wendling D; Societe de pathologie infectieuse de langue francaise. French guidelines for the management of chikungunya (acute and persistent presentations). November 2014. Med Mal Infect. 2015 Jul;45(7):243-63. doi: 10.1016/j.medmal.2015.05.007. Epub 2015 Jun 25. No abstract available.

    PubMed 26119684

  • Silva NMD, Teixeira RAG, Cardoso CG, Siqueira Junior JB, Coelho GE, Oliveira ESF. Chikungunya surveillance in Brazil: challenges in the context of Public Health. Epidemiol Serv Saude. 2018 Sep 3;27(3):e2017127. doi: 10.5123/S1679-49742018000300003. English, Portuguese.

    PubMed 30183867

  • Silva LA, Dermody TS. Chikungunya virus: epidemiology, replication, disease mechanisms, and prospective intervention strategies. J Clin Invest. 2017 Mar 1;127(3):737-749. doi: 10.1172/JCI84417. Epub 2017 Mar 1.

    PubMed 28248203

  • Schneider M, Narciso-Abraham M, Hadl S, McMahon R, Toepfer S, Fuchs U, Hochreiter R, Bitzer A, Kosulin K, Larcher-Senn J, Mader R, Dubischar K, Zoihsl O, Jaramillo JC, Eder-Lingelbach S, Buerger V, Wressnigg N. Safety and immunogenicity of a single-shot live-attenuated chikungunya vaccine: a double-blind, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Jun 24;401(10394):2138-2147. doi: 10.1016/S0140-6736(23)00641-4. Epub 2023 Jun 12.

    PubMed 37321235

  • McMahon R, Toepfer S, Sattler N, Schneider M, Narciso-Abraham M, Hadl S, Hochreiter R, Kosulin K, Mader R, Zoihsl O, Wressnigg N, Dubischar K, Buerger V, Eder-Lingelbach S, Jaramillo JC. Antibody persistence and safety of a live-attenuated chikungunya virus vaccine up to 2 years after single-dose administration in adults in the USA: a single-arm, multicentre, phase 3b study. Lancet Infect Dis. 2024 Dec;24(12):1383-1392. doi: 10.1016/S1473-3099(24)00357-8. Epub 2024 Aug 12.

    PubMed 39146946

  • LUMSDEN WH. An epidemic of virus disease in Southern Province, Tanganyika Territory, in 1952-53. II. General description and epidemiology. Trans R Soc Trop Med Hyg. 1955 Jan;49(1):33-57. doi: 10.1016/0035-9203(55)90081-x. No abstract available.

    PubMed 14373835

  • Gould EA, Gallian P, De Lamballerie X, Charrel RN. First cases of autochthonous dengue fever and chikungunya fever in France: from bad dream to reality! Clin Microbiol Infect. 2010 Dec;16(12):1702-4. doi: 10.1111/j.1469-0691.2010.03386.x. No abstract available.

    PubMed 21040155

  • Cunha RVD, Trinta KS. Chikungunya virus: clinical aspects and treatment - A Review. Mem Inst Oswaldo Cruz. 2017 Aug;112(8):523-531. doi: 10.1590/0074-02760170044.

    PubMed 28767976

  • Buerger V, Hadl S, Schneider M, Schaden M, Hochreiter R, Bitzer A, Kosulin K, Mader R, Zoihsl O, Pfeiffer A, Loch AP, Morandi E Jr, Nogueira ML, de Brito CAA, Croda J, Teixeira MM, Coelho IC, Gurgel R, da Fonseca AJ, de Lacerda MVG, Moreira ED Jr, Veiga APR, Dubischar K, Wressnigg N, Eder-Lingelbach S, Jaramillo JC. Safety and immunogenicity of a live-attenuated chikungunya virus vaccine in endemic areas of Brazil: interim results of a double-blind, randomised, placebo-controlled phase 3 trial in adolescents. Lancet Infect Dis. 2025 Jan;25(1):114-125. doi: 10.1016/S1473-3099(24)00458-4. Epub 2024 Sep 5.

    PubMed 39243794

  • Bartholomeeusen K, Daniel M, LaBeaud DA, Gasque P, Peeling RW, Stephenson KE, Ng LFP, Arien KK. Chikungunya fever. Nat Rev Dis Primers. 2023 Apr 6;9(1):17. doi: 10.1038/s41572-023-00429-2.

    PubMed 37024497

  • Bandyopadhyay D, Ghosh SK. Mucocutaneous manifestations of Chikungunya fever. Indian J Dermatol. 2010;55(1):64-7. doi: 10.4103/0019-5154.60356.

    PubMed 20418982

  • Abdelnabi R, Neyts J, Delang L. Towards antivirals against chikungunya virus. Antiviral Res. 2015 Sep;121:59-68. doi: 10.1016/j.antiviral.2015.06.017. Epub 2015 Jun 25.

    PubMed 26119058

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IXCHIQ vaccine in people with Healthy Adult and Healthy Adolescents, run by Mauro Martins Teixeira at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pedro R J Almeida, MD, MSc (+55 31 995166160, pedrojesus@ufmg.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Celular immunogenicity (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07846293, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.

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Evaluation of IXCHIQ® Vaccine Immunogenicity | AzTrials