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.
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
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;
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- 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.
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.
- Conditions
- Healthy Adult, Healthy Adolescents
- 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 group | Role | What they receive |
|---|---|---|
| IXCHIQ vaccine | Experimental | IXCHIQ vaccine Receives: Biological: IXCHIQ vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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.
- First posted29 Sep 2026
- Study start24 Sep 2026 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mauro Martins Teixeira
- Sponsor type
- University, hospital or other
- Collaborators
- FAPEMIG - Fundação de Amparo a Pesquisa do Estado de Minas Gerais
- Responsible party
- Sponsor-investigator, Mauro Martins Teixeira, Federal University of Minas Gerais
- Investigators
- Mauro M Teixeira, MD, Phd, Principal investigator, Federal University of Minas Gerais
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 41652122Thiberville 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 23811281Simon 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 26119684Silva 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 30183867Silva 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 28248203Schneider 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 37321235McMahon 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 39146946LUMSDEN 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 14373835Gould 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 21040155Cunha 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 28767976Buerger 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 39243794Bartholomeeusen 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 37024497Bandyopadhyay D, Ghosh SK. Mucocutaneous manifestations of Chikungunya fever. Indian J Dermatol. 2010;55(1):64-7. doi: 10.4103/0019-5154.60356.
PubMed 20418982Abdelnabi 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