DenguePhase 3NCT02406729
Phase III Trial to Evaluate Efficacy and Safety of a Tetravalent Dengue Vaccine
A Phase 3 study testing Dengue 1,2,3,4 (attenuated) vaccine in people with Dengue, run by Butantan Institute at 17 sites in Brazil.
Trial summary
This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute. The study will be carried out in multiple sites in Brazil. Read more about this study
- Who is it for?
- Ages 24 months to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Dengue 1,2,3,4 (attenuated) vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16,935 participants
- Where
- 17 sitesBrazil
- Study dates
- 22 Feb 2016to Nov 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 24 months to 59 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age;
- Agree with periodic contacts, either/or by phone, electronic means, and home visits.
- Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form.
Who cannot join
- For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination;
- Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination;
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
- Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;
- History of severe allergic reactions or anaphylaxis to the vaccine or to components of the vaccine in study;
Show all 14Show fewer
- History of asplenia;
- Use of any investigational product within 28 days before or after receiving this study vaccination;
- Has participated in another clinical trial six months prior to inclusion in the study or planning to participate in another clinical trial within 2 years following inclusion;
- Use of immunosuppressant drugs such as: antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use (except topical or nasal). For this protocol will be considered for exclusion use of corticosteroids 3 months prior to the inclusion in the study and 6 months prior to the inclusion for the other therapies mentioned, and planned use of any immunosuppressant therapy within 2 years following inclusion in the study. It will be considered immunosuppressive dose of corticosteroids the equivalent to a dose ≥20 mg of prednisone per day for adults and the equivalent of prednisone at 2 mg/kg/day for children for over 7 days;
- Have received blood products in the past three months, including transfusions or immunoglobulin, or scheduled administration of blood products or immunoglobulin for the following 2 years after vaccination;
- Fever or suspected fever within 72 hours prior to vaccination or axillary temperature greater than 37,8°C on the day of vaccination (inclusion might be postponed until participant has completed 72 hours of no fever);
- Have received live virus vaccine within 28 days or killed virus vaccine in the last 14 days prior to vaccination, or have a scheduled immunization during the first 28 days after receiving the investigational product;
- Any other condition that might put in risk the safety/rights of a potential participant or hurdle his/her compliance with this protocol in investigator's opinion or his representative physician.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Brazil17 sites
Universidade Federal de Minas Gerais
Belo Horizonte, Minas Gerais, 30750-140
Universidade Federal de Roraima - UFRR
Boa Vista, Roraima, 69304-000
Universidade de Brasília
Brasília, Federal District, 71691-082
Universidade Federal de Mato Grosso do Sul
Campo Grande, Mato Grosso do Sul, 79070-900
Hospital Universitário Júlio Müller da Universidade Federal de Mato Grosso
Cuiabá, Mount, 78048-610
Universidade Federal do Ceará
Fortaleza, Ceará, 60430-160
Universidade Federal de Sergipe
Laranjeiras, Sergipe, 49170-000
Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, Amazonas, 69040-000
Hospital Escola da Universidade Federal de Pelotas (HEUFPel)
Pelotas, Rio Grande do Sul, 96020-360
Hospital São Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90619-900
Centro de Pesquisas em Medicina Tropical de Rondônia (CEPEM)
Porto Velho, Rondônia, 78918-791
Centro de Pesquisas Aggeu Magalhães - Fiocruz Pernambuco
Recife, Pernambuco, 50740-465
Instituto de Infectologia Evandro Chagas - Fiocruz
Rio de Janeiro, 21710-232
Faculdade de Medicina de São José do Rio Preto - FAMERP
São José do Rio Preto, São Paulo, 15090-000
Santa Casa de Misericórdia de São Paulo - CSEBF
São Paulo, São Paulo, 01133-020
HCFMUSP
São Paulo, 05403-000
Instituto Gonçalo Muniz - Fiocruz Bahia
Simões Filho, Estado de Bahia, 43700-000
About this study
Official title: Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Immunogenicity of the Dengue 1, 2, 3, 4 (Attenuated) Vaccine From Instituto Butantan
This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.
The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.
Read more
Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.
For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.
The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.
All participants will be followed up for five years to verify dengue incidence, regardless severity.
- Conditions
- Dengue
- Being tested
- Dengue 1,2,3,4 (attenuated) vaccine, Placebo
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dengue 1,2,3,4 (attenuated) vaccineBiological
Also called Butantan DV, TetraVax-DV-TV003
Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
PlaceboOther
Route:subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Dengue 1,2,3,4 (attenuated) vaccine | Experimental | Dengue 1,2,3,4 (attenuated) vaccine Single dose, SC Receives: Biological: Dengue 1,2,3,4 (attenuated) vaccine |
| Placebo | Placebo comparator | Placebo Single dose, SC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy (incidence density of symptomatic dengue cases, virologically confirmed)
The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1.
Measured: Five years post vaccination, all cases after 28 days post-vaccination
Safety (adverse reactions)
The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination.
Measured: In the first 21 days post-vaccination
Secondary outcomes (7)
Efficacy (incidence density of dengue cases confirmed virologically, regarding previous exposure to dengue viruses. )
The incidence density of dengue cases confirmed virologically after 28 days of vaccination, regarding previous exposure to dengue viruses. To demonstrate previous exposure or not to dengue viruses, validated serological methods such as: Elisa IgG Indirect, hemagglutination inhibition test or neutralizing antibodies (e.g., VRNT) or another validated test will be used. In case of doubtful results, more than one technique may be used to confirm the diagnosis.
Measured: at five years post vaccination, all cases after 28 days post-vaccination
Efficacy (incidence density of dengue cases confirmed virologically, regarding the viral serotype)
The incidence density of dengue cases confirmed virologically after 28 days of vaccination, regarding the viral serotype. Virological diagnosis of the viral serotype will be performed using the viral isolation technique or RT-PCR.
Measured: Five years post vaccination, all cases after 28 days post-vaccination
Efficacy (incidence density of cases of severe dengue and/or with alarm signs, including cases hospitalized or not)
Incidence density of cases of severe dengue and/or with alarm signs, including cases hospitalized or not, after 28 days of vaccination. Laboratory confirmation of these cases will occur through serological and/or virological tests.
Measured: Five years post vaccination, all cases after 28 days post-vaccination
Safety ( frequency of solicited and unsolicited local and systemic adverse reactions in participants regarding previous exposure to dengue viruses )
The frequency of solicited and unsolicited local and systemic adverse reactions in participants regarding previous exposure to dengue viruses during the 21-day period after vaccination.
Measured: In the first 21 days post-vaccination
Safety (frequency of unsolicited adverse reactions)
The frequency of unsolicited adverse reactions after 21 days of vaccination until the end of the study.
Measured: Five years post vaccination, all cases after the first 21 days post-vaccination
Immunogenicity (consistency of the immune response to different batches of the vaccine )
The geometric mean of neutralizing antibody titers for each serotype in the fourth week after vaccination in a subgroup of adult participants without previous exposure to dengue immunized with three consecutive batches of dengue vaccine 1,2,3,4 (attenuated).
Measured: 4 weeks post vaccination
Immunogenicity (non-inferiority between simplified formulation vs. conventional formulation)
The geometric mean of titers of neutralizing antibodies for each serotype at Week 4 postvaccination in a subgroup of adult participants without previous prior exposure to dengue and vaccinated with the conventional formulation and the simplified formulation of the dengue 1, 2, 3, 4 (attenuated) vaccine.
Measured: 4 weeks post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2015 (estimated)
- Study start22 Feb 2016
- Primary completion13 Jul 2021
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16,935 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Butantan Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Fernanda C Boulos, MD, PhD, Study director, Instituto Butantan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02406729
- Sponsor's protocol ID
- DEN-03-IB
- Other IDs
- U1111-1168-8679
- Status last verified
- Feb 2024
- First submitted
- 30 Mar 2015
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Precioso AR, Palacios R, Thome B, Mondini G, Braga P, Kalil J. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine. Vaccine. 2015 Dec 10;33(50):7121-5. doi: 10.1016/j.vaccine.2015.09.105. Epub 2015 Oct 14.
PubMed 26458796Kallas EG, Moreira JA, Patino EG, Braga PE, Tenorio JCV, Alves LBO, Infante V, Silveira DHR, Miraglia JL, Cintra MAT, 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, Cassio de Moraes J, Estofolete CF, Freitas AC, Dos Santos CLS, Timenetsky MDCST, Whitehead SS, Durbin AP, Esteves-Jaramillo A, Shekar T, Lee JJ, Chen Q, Macey J, Vaidya S, Coller BG, Boulos FC, Nogueira ML, Lacerda MVG. Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine. Nat Med. 2026 Apr;32(4):1393-1400. doi: 10.1038/s41591-026-04255-3. Epub 2026 Mar 4.
PubMed 41781546Peixoto de Miranda EJF, de Sousa Moreira JA, da Silva Braga R, Silveira DHR, Infante V, de Oliveira Alves LB, de Camargo Vieira Tenorio J, Dos Santos Silva GF, Patino EG, de Mesquita Pacheco PHT, Ramos F, Oliveira DS, Kallas EG, Boulos FC. Randomized, double-blind, placebo-controlled, phase 3 trial to demonstrate lot-to-lot consistency of 3 lots of the simplified formulation of Butantan-dengue vaccine. Vaccine. 2025 Nov 14;66:127836. doi: 10.1016/j.vaccine.2025.127836. Epub 2025 Oct 14.
PubMed 41092804Nogueira 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 38294972
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy, Safety, and Immunogenicity of the Dengue 1, 2, 3, 4 (Attenuated) Vaccine From Instituto Butantan
- ClinicalTrials.gov ID
- NCT02406729
- Acronym / sponsor ID
- DEN-03-IB
- Conditions
- Dengue
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16,935 participants (estimated)
- Lead sponsor
- Butantan InstituteOther government
- Study start
- 22 Feb 2016 (actual)
- Primary completion
- 13 Jul 2021 (actual)
- Study completion
- Nov 2024 (estimated)
- First posted
- 2 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, multicenter, double-blind, placebo-controlled Phase III study that will evaluate efficacy and safety of a live attenuated, tetravalent, lyophilized dengue vaccine produced by Butantan Institute.
The study will be carried out in multiple sites in Brazil. The study will be community-based in select urban areas where there's dengue transmission.
Study's intervention will be a single dose of the tetravalent dengue vaccine or placebo in a ratio 2:1. For efficacy analysis will be considered all dengue cases occurring after 28 days post-vaccination in the entire population of 16944 participants.
For safety analysis participants will be divided in three age groups: 18 to 59 ys, 7-17 ys and 2 to 6 ys. In each of these age groups there will be a minimum of 4992 participants. The age groups of 18 to 59 ys and 7 to 17 ys will start first. Once safety data for the first 21 days after vaccination is analysed for 450 participants in 7-to17-ys age group, the following group, of 2 to 6 ys, will start.
The study's hypothesis is that the vaccine under investigation and produced by Butantan Institute is safe and provides protection against dengue symptomatic disease of 80% or more with a lower bound of the 95% confidence interval of 25%. This way, the expected number of dengue cases virologically confirmed is 24 or more which will provide a response in terms of vaccine efficacy.
All participants will be followed up for five years to verify dengue incidence, regardless severity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dengue 1,2,3,4 (attenuated) vaccine | Experimental | Biological: Dengue 1,2,3,4 (attenuated) vaccineDengue 1,2,3,4 (attenuated) vaccine Single dose, SC |
| Placebo | Placebo comparator | Other: PlaceboPlacebo Single dose, SC |
Who may qualify
- Ages
- 24 months to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Children who have completed 24 months of age, adolescents and adults who have not completed 60 years of age;
- Agree with periodic contacts, either/or by phone, electronic means, and home visits.
- Show voluntary intention to participate in the study, documented by the participant's or participant's legal representative's signature of the informed consent form.
Key exclusion criteria (14 listed)
- For women: Pregnancy (confirmed by positive beta-hCG test) or breastfeeding;
- Evidence of active neurological, cardiac, pulmonary, hepatic or renal disease as per clinical history and/or physical examination;
- Compromised immune system diseases including: decompensated diabetes mellitus, cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and not controlled autoimmune, as per clinical history and/or physical examination;
- Behavioral, cognitive or psychiatric disease that in the opinion of the principal investigator or his representative physician, affects the participant ability to understand and cooperate with all study protocol requirements;
- Abusive usage of alcohol or drugs in the past 12 months that has caused medical, professional or family problems, indicated by clinical history;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dengue 1,2,3,4 (attenuated) vaccineAlso: Butantan DV, TetraVax-DV-TV003Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous | Biological | Dengue 1,2,3,4 (attenuated) vaccine |
| PlaceboRoute:subcutaneous | Other | Placebo |
Primary outcome
Efficacy (incidence density of symptomatic dengue cases, virologically confirmed)
Time frame: Five years post vaccination, all cases after 28 days post-vaccination
The primary efficacy outcome is incidence density of symptomatic dengue cases, virologically confirmed, after 28 days post-vaccination. Virological confirmation might be done by viral isolation, RT-PCR and/or detection of NS1.
Safety (adverse reactions)
Time frame: In the first 21 days post-vaccination
The primary safety outcome is the frequency of local and systemic adverse reactions, solicited and non-solicited in the three age groups, within the first 21 days post-vaccination. Adverse reactions are defined as adverse events that have a reasonable causal relationship with vaccination.
7 secondary outcomes
Efficacy (incidence density of dengue cases confirmed virologically, regarding previous exposure to dengue viruses. )
Time frame: at five years post vaccination, all cases after 28 days post-vaccination
Efficacy (incidence density of dengue cases confirmed virologically, regarding the viral serotype)
Time frame: Five years post vaccination, all cases after 28 days post-vaccination
Efficacy (incidence density of cases of severe dengue and/or with alarm signs, including cases hospitalized or not)
Time frame: Five years post vaccination, all cases after 28 days post-vaccination
Safety ( frequency of solicited and unsolicited local and systemic adverse reactions in participants regarding previous exposure to dengue viruses )
Time frame: In the first 21 days post-vaccination
Safety (frequency of unsolicited adverse reactions)
Time frame: Five years post vaccination, all cases after the first 21 days post-vaccination
Immunogenicity (consistency of the immune response to different batches of the vaccine )
Time frame: 4 weeks post vaccination
Immunogenicity (non-inferiority between simplified formulation vs. conventional formulation)
Time frame: 4 weeks post vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Background: PubMed 26458796Precioso AR, Palacios R, Thome B, Mondini G, Braga P, Kalil J. Clinical evaluation strategies for a live attenuated tetravalent dengue vaccine. Vaccine. 2015 Dec 10;33(50):7121-5. doi: 10.1016/j.vaccine.2015.09.105. Epub 2015 Oct 14.
- Derived from this study: PubMed 41781546Kallas EG, Moreira JA, Patino EG, Braga PE, Tenorio JCV, Alves LBO, Infante V, Silveira DHR, Miraglia JL, Cintra MAT, 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, Cassio de Moraes J, Estofolete CF, Freitas AC, Dos Santos CLS, Timenetsky MDCST, Whitehead SS, Durbin AP, Esteves-Jaramillo A, Shekar T, Lee JJ, Chen Q, Macey J, Vaidya S, Coller BG, Boulos FC, Nogueira ML, Lacerda MVG. Long-term efficacy and safety of the single-dose tetravalent Butantan dengue vaccine. Nat Med. 2026 Apr;32(4):1393-1400. doi: 10.1038/s41591-026-04255-3. Epub 2026 Mar 4.
- Derived from this study: PubMed 41092804Peixoto de Miranda EJF, de Sousa Moreira JA, da Silva Braga R, Silveira DHR, Infante V, de Oliveira Alves LB, de Camargo Vieira Tenorio J, Dos Santos Silva GF, Patino EG, de Mesquita Pacheco PHT, Ramos F, Oliveira DS, Kallas EG, Boulos FC. Randomized, double-blind, placebo-controlled, phase 3 trial to demonstrate lot-to-lot consistency of 3 lots of the simplified formulation of Butantan-dengue vaccine. Vaccine. 2025 Nov 14;66:127836. doi: 10.1016/j.vaccine.2025.127836. Epub 2025 Oct 14.
- Derived from this study: PubMed 39116904Nogueira 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.
- Derived from this study: PubMed 38294972Kallas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernanda C Boulos, MD, PhD study director
Instituto Butantan
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dengue 1,2,3,4 (attenuated) vaccine in people with Dengue, run by Butantan Institute at 17 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 14 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: status not confirmed, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy (incidence density of symptomatic dengue cases, virologically confirmed) (time frame: Five years post vaccination, all cases after 28 days post-vaccination). 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 NCT02406729, which also lists 5 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 15 Feb 2024.