DenguePhase 3NCT06973772
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.
A Phase 3 study testing DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555), DENGUE: Dengue 1,2,3,4 (attenuated) vaccine and Chikungunya (CHIKV) live attenuated vaccine (VLA1555) in people with Dengue and Chikungunya, run by Butantan Institute at 7 sites in Brazil.
Trial summary
This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue, Chikungunya
- What is being tested?
- DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555), DENGUE: Dengue 1,2,3,4 (attenuated) vaccine and Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 7 sitesBrazil
- Study dates
- 31 Mar 2027to Oct 2027
- Phase
- Phase 3
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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female adults aged 18 to 59 years at the time of vaccination.
- Signed informed consent by the participant or their legal representatives.
- Ability to understand, based on the investigator's assessment, and agree to comply with all study procedures, including blood collection.
Who cannot join
- Participation in another clinical trial within 28 days prior to screening or planned participation in another clinical study during the trial period.
- 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.
- 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.
- Known hypersensitivity to any component of the vaccines.
- Thrombocytopenia or bleeding disorders that contraindicate intramuscular vaccination or venipuncture for blood collection.
- Receipt of immunoglobulins, blood, or blood products within 180 days prior to screening.
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- 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).
- 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.
- Receipt of antineoplastic agents, immunosuppressants, immunomodulators, or radiotherapy within the last 180 days prior to screening.
- 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).
- Abuse of alcohol and illicit drugs within the past 12 months before screening that may compromise study compliance, at the investigator's discretion.
- 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.
- 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.
- 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.
- 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.
- Previous receipt of any dengue or chikungunya vaccine.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Brazil7 sites
Centro Médico de São Francisco
Curitiba, Paraná, 80810-050
Hospital São Vicente de Paulo
Passo Fundo, Rio Grande do Sul, 99010-080
Alexandre Pereira Tognon, MD, PhD, +55 (54) 9991-1092, aptognon@hsvp.com.br
Hospital Escola da Universidade Federal de Pelotas
Pelotas, Rio Grande do Sul, 96040-010
Danise Senna Oliveira, MD, PhD, +55 (53) 8133-4454, daniseoliveira@gmail.com
Reumacenter
Porto Alegre, Rio Grande do Sul, 90480-000
Mauro Waldemar Keiserman, MD, PhD, +55 (51) 99808-9284, mk.reumatomauro@gmail.com
UBEA - União Brasileira de Educação e Assistência Hospital São Lucas da PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000
Fabiano Ramos, MD, PhD, +55 (51) 9656-6533, fabianoramos.infecto@gmail.com
Instituto de Pesquisa em AIDS do Estado do Rio Grande do Sul - IPARGS
Porto Alegre, Rio Grande do Sul, 91350-180
Breno Riegel Santos, MD, PhD, +55 (51) 99289-4951, breno@ghc.com.br
Centro de Pesquisa Inova
Toledo, Paraná, 85902-010
Regis Goulart Rosa, MD, PhD, +55 (51) 9453 8804, regisgoulartrosa@gmail.com
About this study
Official title: Phase 3b, Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines in Adults Aged 18 to 59 Years.
This randomized, controlled, double blind trial aims at assessing the safety and immunogenicity profiles of the co-administered Live Attenuated Dengue and Chikungunya vaccines comparatively to the isolated administration, in the adult population aged 18 to 59 years without prior exposure to either arbovirus.
Read the detailed description
A Phase 3b multicenter, randomized, controlled, double-blind clinical trial was designed to evaluate the Immunogenicity (non-inferiority), 28 days post-immunization, for each Dengue and Chikungunya serotypes, as well as the safety, 21 days post-immunization, of the co-administration of the live attenuated Dengue and Chikungunya vaccines compared to the separate administration in adults aged 18 to 59 years without prior exposure to either arbovirus.
- Conditions
- Dengue, Chikungunya
- Being tested
- DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555), DENGUE: Dengue 1,2,3,4 (attenuated) vaccine, Chikungunya (CHIKV) live attenuated vaccine (VLA1555)
- Keywords
- dengue, chikungunya, coadministration regimen
- Medical subject headings
- Dengue, Chikungunya Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555)Biological
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) vaccineBiological
DENGUE: Dose 10^2.5-4.1 PFU per virus (1,2,3,4) Route: Subcutaneous
Chikungunya (CHIKV) live attenuated vaccine (VLA1555)Biological
CHIKUNGUNYA: Dose >= 3.0 log TCID50 per 0.5 mL Route: Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Dengue and Chikungunya vaccines co-administered | Experimental | A single dose of Butantan-DV + a single dose of VLA1555, administered concomitantly in opposite arms on Day 1. Receives: Biological: DENGUE: Dengue 1,2,3,4 (attenuated) vaccine CHIKUNGUNYA: Chikungunya (CHIKV) live attenuated vaccine (VLA1555) |
| Dengue vaccine only | Experimental | A single dose of Butantan-DV + placebo, administered concomitantly in opposite arms on Day 1. Receives: Biological: DENGUE: Dengue 1,2,3,4 (attenuated) vaccine |
| Chikungunya vaccine only | Experimental | A single dose of VLA1555 + placebo, administered concomitantly in opposite arms on Day 1. Receives: Biological: Chikungunya (CHIKV) live attenuated vaccine (VLA1555) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity Primary
Demonstrate the non-inferiority of the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, for each Dengue serotype and Chikungunya in the adult population aged 18 to 59 years without prior exposure to either arbovirus, by calculating the Geometric Mean Titer (GMT) and the GMT ratio, post-immunization for each dengue serotype and chikungunya, across all intervention groups.
Measured: 28 days post-immunization
Safety Primary
Assess the safety profile of co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, in the adult population aged 18 to 59 years without prior exposure to either arbovirus, through the frequency of participants with solicited (local and systemic) and unsolicited adverse events (AEs), in all intervention groups.
Measured: 21 days post-immunization
Secondary outcomes (5)
Immunogenicity Secondary 1
Assess the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus, comparing the seroconversion rates, for each dengue serotype and chikungunya, across all intervention groups.
Measured: 28 days post-immunization
Immunogenicity Secondary 2.
Assess the antibody response of co-administered Dengue and Chikungunya vaccines compared to Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus, comparing the Geometric Mean Titer and the GMT ratio, for each dengue serotype and chikungunya, across all intervention groups.
Measured: 180 days post-immunization.
Safety Secondary 1.
Describe and compare the safety profile, by listing the Adverse Events of the co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, reported in adults aged 18 to 59 years without prior exposure to either arbovirus.
Measured: up to 21 days post-immunization.
Safety Secondary 2.
Describe and compare the safety profile by listing Adverse Events of the co-administered Dengue and Chikungunya vaccines and Dengue and Chikungunya vaccines administered separately, in adults aged 18 to 59 years without prior exposure to either arbovirus.
Measured: 180 days post-immunization
Safety Secondary 3.
Describe post-vaccination viremia cases (manifestations).
Measured: Days 1, 6, 9, 16, and 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2025
- Study start31 Mar 2027 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DengueStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 3b Multicenter, Randomized, Controlled, Double-Blind Clinical Trial to Evaluate the Immunogenicity and Safety of the Co-administration of Live Attenuated Dengue and Chikungunya Vaccines Compared to Separate Administration.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06973772
- Sponsor's protocol ID
- CODENCHIK-01-IB
- Status last verified
- Mar 2026
- First submitted
- 28 Apr 2025
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37039318Wressnigg 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.
PubMed 32497524Schneider 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 37321235Nogueira 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.
PubMed 39116904Kallas 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.
PubMed 38294972Kallas 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.
PubMed 32220283Chen 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.
PubMed 39255380