AzTrials
AzTrials

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.

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
Search all trials

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)
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
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 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.
Show all 16Show fewer
  • 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.

Clóvis Arns da Cunha, MD, PhD contact

+55 (41) 99828-8444

arnscunha@gmail.com

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

Other trials in Brazil

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 groups in NCT06973772
Study groupRoleWhat they receive
Dengue and Chikungunya vaccines co-administeredExperimentalA 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 onlyExperimentalA 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 onlyExperimentalA 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.

  1. 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

  2. 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)

  1. 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

  2. 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.

  3. 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.

  4. 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

  5. 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.

  1. First posted15 May 2025
  2. Study start31 Mar 2027 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionOct 2027 (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 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)
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 37039318

  • 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.

    PubMed 32497524

  • 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

  • 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.

    PubMed 39116904

  • 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.

    PubMed 38294972

  • 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.

    PubMed 32220283

  • 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.

    PubMed 39255380

Questions about this trial

What is this clinical trial studying?

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.

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 3 inclusion and 16 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Clóvis Arns da Cunha, MD, PhD (+55 (41) 99828-8444, arnscunha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity Primary (time frame: 28 days post-immunization). The study lists 2 primary outcomes in all. 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 NCT06973772, which also lists 7 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 16 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in