A Phase 3 interventional study of Dengue 1,2,3,4 (attenuated) vaccine in Dengue, sponsored by Butantan Institute. Active, not recruiting at 5 sites in Brazil. Open to participants aged 40 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Butantan Institute · Phase 3, Interventional, and Prevention
This is a randomized, double-blind (60 -79 years) and open-label (40-59 years), three-arm parallel Phase 3b, multicenter study to evaluate the safety and non-inferiority of the humoral immune response of the Butantan Dengue vaccine (Dengue 1,2,3,4 (attenuated)) in participants aged 60 -79 years (elderly) compared to participants aged 40 to 59 years (adults), with or without previous dengue and healthy based on clinical examination.
The study aims to evaluate the non-inferiority of the immune response induced by the Dengue 1,2,3,4 (attenuated) vaccine in participants aged 60 - 79 years old (elderly) compared to participants aged 40 to 59 years on Day 42 + 7 days after vaccination. The primary analysis will include the immunogenicity cohort (n=460 participants, allocated 1:1). The primary outcome is the proportion of neutralizing antibody seroconversion measured by plaque reduction neutralization test (PRNT50), for each dengue serotype, of participants aged 60 - 79 years (elderly) compared with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination. The primary safety outcome will be the frequency and intensity of solicited and unsolicited adverse reactions from vaccination to Day 22 post-vaccination among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without prior exposure to dengue. The study will last one year in order to assess the duration of the immune response and serious adverse events (SAE) and events of special interest (SIAE). Throughout the study period, there will be surveillance of suspected and confirmed cases of dengue, chikungunya fever and Zika virus fever. Therefore, if the null hypothesis is rejected, the immunogenicity and safety results of immunobridging will be used to expand the use of Dengue 1,2,3,4 (attenuated) for the age group of 60 - 79 years old.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 997 is above the median of 132 across 197 interventional studies indexed under Dengue.
Browse Dengue studies →Butantan Institute is the lead sponsor of 31 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
a. Healthy participants aged between 40 and 79 years at the time of study entry, with or without a history of exposure to dengue fever;
b. Agree to periodic contact by telephone, electronic means, and home visits and to the research center;
c. Participants with must be using some effective method at screening and continue using it for up to 90 days after the intervention; except in cases where the volunteer declares that she is not at risk of becoming pregnant, either by not engaging in sexual activities or by engaging in them in a non-reproductive manner, up to 90 days after vaccination;
d. Demonstrate intent to participate in the study, documented by the participant's signature of the form, as well as the study procedures, including completing the Participant Diaries, blood collection, and being available for scheduled study visits and contacts.
Exclusion Criteria:
a. For female participants with : pregnancy (confirmed by positive β-hCG test), breastfeeding or manifest intention to have sexual practices with reproductive potential without using a method in the 90 days following vaccination;
b. Planned donation of blood, semen or eggs in the 90 days following vaccination;
c. Evidence of active uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease according to anamnesis or physical examination, at the discretion of the investigator;
d. Diseases that compromise the immune system, including: decompensated diabetes mellitus, active neoplasms or history of neoplasms in the last five years (except basal cell carcinoma), congenital or acquired immunodeficiencies (including /AIDS), solid organ transplants (heart, liver, pancreas, lung, kidney) or uncontrolled diseases according to anamnesis or physical examination, as well as a history of liver failure, heart failure or terminal chronic kidney disease or dialysis;
e. Behavioral, cognitive, or psychiatric illness that, in the opinion of the principal investigator or his/her medical representative, affects the potential participant's ability to understand and comply with the requirements of the study protocol;
f. Any abuse of alcohol or drugs in the last 12 months prior to enrollment in the study that has caused medical, professional, or family problems, as indicated by the clinical history;
g. History of severe allergic reaction or anaphylaxis to the vaccine or components of the study vaccine;
h. History of asplenia;
i. Participation in another clinical trial with administration of an product during the six months prior to enrollment in the study or scheduled participation in another clinical trial in the 12 months following enrollment;
j. Previous participation in a dengue vaccine evaluation study or previous exposure to dengue vaccine;
k. Use of therapies six months prior to enrollment in the study or their scheduled use in the 12 months following enrollment. The following immunosuppressive therapies will be considered: antineoplastic chemotherapy, radiotherapy, immunosuppressants to induce tolerance to transplants, monoclonal antibody therapy for the treatment of rheumatological diseases, among others;
l.Having received an immunosuppressive dose of in the last three months prior to inclusion in the study or administration of an immunosuppressive dose of corticosteroid for the 12 months following inclusion in the study. The dose of corticosteroid considered immunosuppressive is the equivalent of prednisone at a dose of 20 mg/day, for adults, for 14 days (cumulative dose equivalent to at least 280 mg of prednisone). Continuous use of topical or nasal corticosteroid is not considered immunosuppressive;
m. Having received blood products (transfusions or immunoglobulins) in the last three months prior to inclusion in the study, or scheduled administration of blood products or immunoglobulin in the 12 months following inclusion in the study;
n. Fever, suspected or measured, in the 72 hours prior to vaccination or axillary temperature ≥ 37.8°C on the day of vaccination (inclusion may be postponed until the potential participant has been fever-free for 72 hours);
o. Having received a in the last 28 days or an inactivated vaccine in the last 14 days prior to inclusion in the study, or having been immunized within 12 months of inclusion in the study;
p. Any other condition that, in the opinion of the principal investigator or his/her medical representative, may jeopardize the safety or rights of a potential participant or that prevents him/her from complying with this protocol.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants (60-79y) receiving Butantan DV (N=690)
Biological: Dengue 1,2,3,4 (attenuated) vaccine
Participants (40-59y) receiving Butantan DV (N=230)
Biological: Dengue 1,2,3,4 (attenuated) vaccine
Participants (60-79y) receiving Placebo (N=77)
Biological: Dengue 1,2,3,4 (attenuated) vaccine
Each 0.5 mL dose of the lyophilized formulation of Dengue 1,2,3,4 (attenuated) presents an approximate concentration of 103.0 PFU of each vaccine virus rDEN1Δ30-1545, rDEN2/4Δ30(ME)-1495,7163, rDEN3Δ30/31-7164, rDEN4Δ30-7132,7163,8308.
Immunogenicity Primary
Proportion of neutralizing antibody seroconversion measured by PRNT50, for each dengue serotype, of participants aged 60 -79 years compared (elderly) with participants aged 40 to 59 years (adults), with or without previous exposure to dengue, on Day 42 + 7 days after vaccination.
Time frame: Day 42+7 days post-vaccination.
Safety Primary 1.
Frequency and intensity of vaccine-related solicited (local and systemic) adverse events, from vaccination to Day 22 + 3 days post-vaccination, among participants aged 60 - 79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.
Time frame: From vaccination to Day 22 + 3 days post-vaccination.
Safety Primary 2.
Frequency and intensity of vaccine-related unsolicited adverse events, from vaccination to Day 22 + 3 days post-vaccination, in participants aged 60-79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue.
Time frame: From vaccination to Day 22 + 3 days post-vaccination.
Immunogenicity Secondary 1.
GMT of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years and of participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 1, Day 42 + 7 days and Day 364 + 28 days after vaccination.
Time frame: Day 1, Day 42 + 7 days and Day 364 + 28 days after vaccination.
Immunogenicity Secondary 2.
GMT ratio of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years compared with participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 42 + 7 days after vaccination.
Time frame: Day 42 + 7 days after vaccination.
Immunogenicity Secondary 3.
GMT ratio of neutralizing antibodies, for each dengue serotype, of participants aged 60-79 years compared with participants aged 40 to 59 years, with or without previous exposure to dengue, on Day 364 + 28 days after vaccination.
Time frame: Day 364 + 28 days after vaccination.
Immunogenicity Secondary 4.
Valence or seropositivity rate for multiple dengue virus serotypes measured by PRNT50 in participants aged 60-79 years and in participants aged 40 to 59 years, with or without previous exposure to dengue, on Days 42 + 7 days and Day 364 + 28 days after vaccination.
Time frame: Days 42 + 7 days and Day 364 + 28 days after vaccination.
Safety Secondary 1.
Frequency and intensity of unsolicited adverse reactions, from Day 22 + 3 days post-vaccination until the end of study follow-up, in elderly participants (60-79 years) and adults (40-59 years), with or without previous exposure to dengue.
Time frame: From Day 22 + 3 days post-vaccination until the end of study.
Safety Secondary 2.
Frequency, intensity and causality of serious adverse events, in elderly participants (60-79 years) and adults (40-59 years), with or without previous exposure to dengue, throughout the study period.
Time frame: Throughout the study period.
Safety Secondary 3.
Frequency, intensity and causality of adverse events of special interest, in elderly participants (60-79 years) and adults (40-59 years), with or without previous exposure to dengue, throughout the study period.
Time frame: Throughout the study period.
Safety Secondary 4.
Frequency of viremia after vaccination at visits on Days 1, 6, 9, 12, 22 and 30 and laboratory abnormalities in a cohort of 56 elderly participants (60-79 years).
Time frame: Days 1, 6, 9, 12, 22 and 30.
Safety Secondary 5.
Frequency of cases of symptomatic vaccine viremia (Day 29) and of virologically confirmed cases of dengue (VCD), chikungunya fever and Zika virus fever in elderly individuals (60-79 years) and adults (40-59 years), throughout the study period.
Time frame: Day 29 and throughout the study period.
Safety Secondary 6.
Frequency of laboratory alterations (aspartate aminotransferase, alanine aminotransferase, total bilirubin, creatinine, blood count) grade 2 or higher among elderly (60-79 years) and adults (40-59 years) on Day 22 + 3 days after vaccination.
Time frame: Day 22 + 3 days after vaccination.
Started Mar 2026 (actual). Primary completion is estimated for Mar 2027, 12 months after the start.
Of 21 phase 3 interventional studies under Dengue, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 12 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Butantan Institute