A Phase 3 interventional study of Butantan-DV (IB) and Butantan-DV (WuXi) in Dengue Fever With Warning Signs, sponsored by Butantan Institute. Not yet recruiting. Open to participants aged 2 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Butantan Institute · Phase 3, Interventional, and Prevention
This randomized, double-blind, three parallel-group, multicenter, phase 3b trial evaluates the safety and immunogenicity of Butantan-DV. The study compares two primary immunization regimens (Butantan-DV/Butantan-DV vs. Butantan-DV/Placebo) across both the 2-11 and 12-17 age cohorts. It also evaluates the manufacturing facility transition for the Butantan-DV dengue vaccine, by comparing the open-label arm WuXi Biologics (Butantan-DV group) to both double-blinded Butantan-DV/Butantan-DV and Butantan-DV/Placebo arms, in adolescents aged 12 to 17.
This randomized three parallel-group trial (one open-label, two double-blinded) evaluates the safety and humoral immunogenicity of a 0.5 mL dose (subcutaneously) of the tetravalent Butantan-DV vaccine against four dengue virus serotypes (DENV-1-4). It will address the two-dose primary immunization regimen superiority in children (2-11 years) or adolescents (12-17 years), in comparison to the one dose regimen versus placebo on Day 29 post second vaccination. The manufacturing facility transition for the Butantan-DV dengue vaccine will evaluate the non-inferiority of humoral immunogenicity between WuXi Biologics formulation (Butantan-DV WuXi) against both Butantan-DV (IB) arms, on Day 29 post first vaccination, in adolescents (12-17 years). Safety endpoint consists in local or systemic solicited and unsolicited adverse events, in children and adolescents up to Day 22 after each vaccine dose.
283 studies on the registry are indexed under Dengue; 44 are open to participants now.
This study's planned enrollment of 1,765 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.
Exclusion Criteria:
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.
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
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.
CD4 count
The number of CD4 cells, a type of white blood cell, in a given amount of blood. It is used to follow how well the immune system is doing in HIV.
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.
Butantan-DV manufactured at the Butantan Institute
Biological: Butantan-DV (IB)
Butantan-DV manufactured at the WuXi Biologics CRDMO
Biological: Butantan-DV (WuXi)
Placebo (0 PFU), solution of the simplified lyophilized formulation, manufactured at the Butantan Institute
Other: Placebo
Butantan-DV manufactured at the Instituto Butantan - Butantan-DV (IB), mean 10³ PFU (per dose), subcutaneously, in the deltoid region.
Butantan-DV manufactured at the WuXi Biologics CRDMO - Butantan-DV (WuXi),mean 10³ PFU (per dose), subcutaneously, in the deltoid region.
Placebo manufactured at the Instituto Butantan - Placebo (IB), mean 0 PFU (per dose), subcutaneously, in the deltoid region.
Immunogenicity - 1
Geometric Mean Fold-Rise ratio of neutralizing antibodies measured by PRNT50 against the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) in participants in the Butantan-DV (IB) + Butantan-DV (IB) group, compared to participants in the Butantan-DV (IB) + Placebo (IB) group, in children aged 2 to 11 years.
Time frame: Group Butantan-DV (IB) + Butantan-DV (IB) on Day 302 and Group Butantan-DV (IB) + Placebo (IB) on Day 29 post vaccination.
Immunogenicity - 2
Geometric Mean Fold-Rise ratio of neutralizing antibodies measured by PRNT50 against the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) in participants of the Butantan-DV (IB) + Butantan-DV (IB) group at Day 302, compared to participants of the Butantan-DV (IB) + Placebo (IB) group at Day 29, in adolescents aged 12 to 17 years.
Time frame: Group Butantan-DV (IB) + Butantan-DV (IB) on Day 302 and Group Butantan-DV (IB) + Placebo (IB) on Day 29 post vaccination.
Immunogenicity - 3
Geometric Mean Fold-Rise ratio of neutralizing antibodies measured by PRNT50 against the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) in participants of the Butantan-DV (WuXi) Group compared to participants of the other two Butantan-DV (IB) groups, in adolescents aged 12 to 17 years.
Time frame: Day 29 post vaccination.
Safety - 1
Frequency of solicited and unsolicited adverse reactions in participants in the Butantan-DV + Butantan-DV group and in participants in the Butantan-DV (IB) + Placebo (IB) group, among children aged 2 to 11 years.
Time frame: First 21 days after each vaccine dose (up to Day 22 and from Day 273 to Day 294).
Safety - 2
Frequency of solicited and unsolicited adverse reactions after each vaccine dose in participants in the Butantan-DV (IB) + Butantan-DV (IB) group and in participants in the Butantan-DV (IB) + Placebo (IB) group, among adolescents aged 12 to 17 years.
Time frame: First 21 days after each vaccine dose (up to Day 22 and from Day 273 to Day 294).
Safety - 3
Frequency of solicited and unsolicited adverse reactions in participants in the Butantan-DV (WuXi) Group and in participants in the other two Butantan-DV (IB) groups who received the first dose of the primary immunization series, among adolescents aged 12 to 17 years.
Time frame: First 21 days after each vaccine dose (up to Day 22).
Immunogenicity - 4
Geometric Mean Fold-Rise ratio (rGMFR) in neutralizing antibody titers measured by PRNT50, for each dengue virus serotype (DENV-1, DENV-2, DENV-3, and DENV-4), postvaccination, for participants in the Butantan-DV (IB) + Butantan-DV (IB) group compared to participants in the Butantan-DV (IB) + Placebo (IB) group, among children aged 2 to 11 years and adolescents aged 12 to 17 years.
Time frame: Day 29 postvaccination.
Immunogenicity - 5
Geometric Mean Fold-Rise ratio (rGMFR) of neutralizing antibody titers measured by PRNT50-for each dengue virus serotype (DENV-1, DENV-2, DENV-3, and DENV-4)-comparing the Butantan-DV (WuXi) Group to the other Butantan-DV (IB) groups that received only the first vaccination.
Time frame: Day 182 postvaccination.
Immunogenicity - 6
Difference between proportions of seroconversion (95% CI) in the Butantan-DV (IB) + Butantan-DV (IB) group and seroconversion in the Butantan-DV (IB) + Placebo (IB) group, for the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). Seroconversion defined as ≥1:10 from a baseline titer \<1:10 post-vaccination or a fourfold increase relative to baseline for a baseline titer ≥1:10.
Time frame: Day 302 in the Butantan-DV (IB) + Butantan-DV (IB) Group and Day 29 in the Butantan-DV (IB) + Placebo (IB) Group.
Immunogenicity - 7
Cellular immune response in a cohort of 50 consecutive participants from the Butantan-DV (IB) + Butantan-DV (IB) group and the Butantan-DV (IB) + Placebo (IB) group, against the four dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4). The immune response will consist of the proportion (%) of DENV-1- through DENV-4-specific CD4+ and CD8+ T cells (producing IFN-γ) following vaccine stimulation.
Time frame: Days 1, 29, 182, 302, and 456 post vaccination.
Safety - 4
Frequency (95% CI and p-value) for the difference in proportions of participants with solicited (local and systemic) and unsolicited adverse reactions comparing the Butantan-DV (IB) + Butantan-DV (IB) group with the Butantan-DV (IB) + Placebo (IB) group, in children aged 2 to 11 years and adolescents aged 12 to 17 years.
Time frame: Period between the second dose and Day 294.
Safety - 5
Frequency (95% CI and p-value) for the difference in proportions of participants with solicited (local and systemic) and unsolicited adverse reactions, among participants in the Butantan-DV (WuXi) Group and participants in the other Butantan-DV (IB) groups who received the first dose of the primary immunization series, in adolescents aged 12 to 17 years.
Time frame: Period between the first dose and Day 22.
Safety - 6
Frequency (95% CI) of the difference in proportions of participants with adverse events requiring medical attention (AERMA) post-vaccination across the three groups, in children aged 2 to 11 years and adolescents aged 12 to 17 years.
Time frame: Day 1 to Day 43 and Day 273 to Day 315
Safety - 7
Frequency (95% CI and p-value) of the difference between proportions, of participants with serious adverse events (SAEs) post-vaccination across the three groups, among children aged 2 to 11 and adolescents aged 12 to 17 years.
Time frame: Throughout the entire study period, an average of 1 year.
Safety - 8
Frequency (95% CI and p-value) of the difference in proportions of participants with adverse events of special interest (AESI) post-vaccination, across the three groups, in children aged 2 to 11 years and adolescents aged 12 to 17 years.
Time frame: Throughout the entire study period, an average of 1 year.
Safety - 9
Frequency (95% CI and p-value) of the difference in proportions of participants with adverse events of special interest (AESI) post-vaccination, across the three groups, in children aged 2 to 11 years and adolescents aged 12 to 17 years.
Time frame: Throughout the entire study period, an average of 1 year.
Safety - 10
Frequency of viremia after each dose of the primary immunization and laboratory changes at visits on in a cohort of 50 adolescent participants aged 12 to 17 years from the Butantan-DV (IB) + Butantan-DV (IB) group and the Butantan-DV (IB) + Placebo (IB) group, for all dengue virus serotypes (DENV-1, DENV-2, DENV-3, and DENV-4) and by valence.
Time frame: Days 1, 6, 9, 12, 22, 273, 279, 282, 285, and 294.
No study locations are listed for this record.
Start is estimated for Feb 2027; primary completion for Feb 2028, 12 months later.
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.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Butantan Institute