Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration in Adults Aged 18 to 59 Years.
NCT ID: NCT06973772
Last Updated: 2025-05-15
Study Results
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Basic Information
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NOT_YET_RECRUITING
PHASE3
900 participants
INTERVENTIONAL
2025-08-31
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Dengue and Chikungunya vaccines co-administered
A single dose of Butantan-DV + a single dose of VLA1555, administered concomitantly in opposite arms on Day 1.
DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
Dengue vaccine only
A single dose of Butantan-DV + placebo, administered concomitantly in opposite arms on Day 1.
DENGUE: Dengue 1,2,3,4 (attenuated) vaccine
DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous
Chikungunya vaccine only
A single dose of VLA1555 + placebo, administered concomitantly in opposite arms on Day 1.
Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
Interventions
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DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
DENGUE: Dengue 1,2,3,4 (attenuated) vaccine
DENGUE: Dose 10\^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous
Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
CHIKUNGUNYA: Dose \>= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
Eligibility Criteria
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Inclusion Criteria
2. Signed informed consent by the participant or their legal representatives.
3. Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.
Exclusion Criteria
2. Pre-existing unstable health condition. An unstable health condition is defined as a disease requiring a change in treatment or hospitalization due to disease worsening within 90 days prior to screening.
3. Vaccination within 14 days prior to screening with any inactivated vaccine or within 28 days prior to screening with any live attenuated vaccine, or planned vaccination with any vaccine up to 28 days after study vaccination.
4. Known hypersensitivity to any component of the vaccines.
5. Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.
6. Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.
7. Altered immunocompetence (immunosuppression, immunodeficiency, or immunocompromise) primary or secondary due to: Clinical conditions (including but not limited to renal failure, liver failure with cirrhosis, heart failure class III or IV according to the New York Heart Association, HIV infection, and asplenia).
8. Use of systemic corticosteroids (oral, intravenous, or intramuscular) at a dose equivalent to ≥20 mg/day of prednisone for more than 14 days or a cumulative dose greater than 280 mg within the last 90 days prior to screening. Topical, inhaled, and intranasal corticosteroids are allowed. Intermittent use (a single dose within the last 30 days prior to screening) of intra-articular corticosteroids is also allowed.
9. Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.
10. Malignancy at the time of screening or a history of malignancy with \<5 years of disease-free status at screening (except for basal cell carcinoma of the skin and localized prostate cancer under active surveillance).
11. Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.
12. Being part of the study team, having a first-degree relative (parents, children, in-laws, stepchildren, sons-in-law, or daughters-in-law) or living in the same household as a study team member.
13. Any other clinical condition that, in the investigator's opinion, may interfere with the study results or pose an additional risk to the participant due to study inclusion.
14. Prior exposure to dengue and chikungunya viruses, i.e., non-reactive IgM and IgG as screened by specific ELISA for both viruses. In case of doubt or indeterminate ELISA results, at least two consecutive samples will be collected. If doubt persists after two test collections, the participant will be excluded.
15. For female participants of childbearing potential: Pregnancy (confirmed by a positive β-hCG test), breastfeeding, or intention to engage in sexual activity with reproductive potential without using a contraceptive method for 90 days following vaccination.
16. Previous receipt of any dengue or chikungunya vaccine.
18 Years
59 Years
ALL
Yes
Sponsors
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Butantan Institute
OTHER_GOV
Responsible Party
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Locations
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Centro Médico de São Francisco
Curitiba, Paraná, Brazil
Centro de Pesquisa Inova
Toledo, Paraná, Brazil
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, Brazil
Reumacenter
Porto Alegre, Rio Grande do Sul, Brazil
UBEA - União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Instituto de Pesquisa em AIDS do Estado do Rio Grande do Sul - IPARGS
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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Central Contacts
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Facility Contacts
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References
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Wressnigg N, Hochreiter R, Zoihsl O, Fritzer A, Bezay N, Klingler A, Lingnau K, Schneider M, Lundberg U, Meinke A, Larcher-Senn J, Corbic-Ramljak I, Eder-Lingelbach S, Dubischar K, Bender W. Single-shot live-attenuated chikungunya vaccine in healthy adults: a phase 1, randomised controlled trial. Lancet Infect Dis. 2020 Oct;20(10):1193-1203. doi: 10.1016/S1473-3099(20)30238-3. Epub 2020 Jun 1.
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.
Nogueira ML, Cintra MAT, Moreira JA, Patino EG, Braga PE, Tenorio JCV, de Oliveira Alves LB, Infante V, Silveira DHR, de Lacerda MVG, Pereira DB, da Fonseca AJ, Gurgel RQ, Coelho IC, Fontes CJF, Marques ETA, Romero GAS, Teixeira MM, Siqueira AM, Boaventura VS, Ramos F, Junior EE, de Moraes JC, Whitehead SS, Esteves-Jaramillo A, Shekar T, Lee JJ, Macey J, Kelner SG, Coller BG, Boulos FC, Kallas EG; Phase 3 Butantan-DV Working Group. Efficacy and safety of Butantan-DV in participants aged 2-59 years through an extended follow-up: results from a double-blind, randomised, placebo-controlled, phase 3, multicentre trial in Brazil. Lancet Infect Dis. 2024 Nov;24(11):1234-1244. doi: 10.1016/S1473-3099(24)00376-1. Epub 2024 Aug 5.
Kallas EG, Cintra MAT, Moreira JA, Patino EG, Braga PE, Tenorio JCV, Infante V, Palacios R, de Lacerda MVG, Batista Pereira D, da Fonseca AJ, Gurgel RQ, Coelho IC, Fontes CJF, Marques ETA, Romero GAS, Teixeira MM, Siqueira AM, Barral AMP, Boaventura VS, Ramos F, Elias Junior E, Cassio de Moraes J, Covas DT, Kalil J, Precioso AR, Whitehead SS, Esteves-Jaramillo A, Shekar T, Lee JJ, Macey J, Kelner SG, Coller BG, Boulos FC, Nogueira ML. Live, Attenuated, Tetravalent Butantan-Dengue Vaccine in Children and Adults. N Engl J Med. 2024 Feb 1;390(5):397-408. doi: 10.1056/NEJMoa2301790.
Kallas EG, Precioso AR, Palacios R, Thome B, Braga PE, Vanni T, Campos LMA, Ferrari L, Mondini G, da Graca Salomao M, da Silva A, Espinola HM, do Prado Santos J, Santos CLS, Timenetsky MDCST, Miraglia JL, Gallina NMF, Weiskopf D, Sette A, Goulart R, Salles RT, Maestri A, Sallum AME, Farhat SCL, Sakita NK, Ferreira JCOA, Silveira CGT, Costa PR, Raw I, Whitehead SS, Durbin AP, Kalil J. Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial. Lancet Infect Dis. 2020 Jul;20(7):839-850. doi: 10.1016/S1473-3099(20)30023-2. Epub 2020 Mar 24.
Chen LH, Fritzer A, Hochreiter R, Dubischar K, Meyer S. From bench to clinic: the development of VLA1553/IXCHIQ, a live-attenuated chikungunya vaccine. J Travel Med. 2024 Oct 19;31(7):taae123. doi: 10.1093/jtm/taae123.
Bonanni P, Steffen R, Schelling J, Balaisyte-Jazone L, Posiuniene I, Zatonski M, Van Damme P. Vaccine co-administration in adults: An effective way to improve vaccination coverage. Hum Vaccin Immunother. 2023 Dec 31;19(1):2195786. doi: 10.1080/21645515.2023.2195786. Epub 2023 Apr 11.
Other Identifiers
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CODENCHIK-01-IB
Identifier Type: -
Identifier Source: org_study_id
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