Trial · NCT05710224
Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002)
NCT05710224, Phase 2, Completed, Butantan Institute; results first posted 2025-11-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002). Trials, record NCT05710224. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05710224
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Bridging Study Between V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil (V181 - 002)
- NCT number
- NCT05710224
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,364 participants, actual
- Lead sponsor
- Butantan Institute
- Conditions
- Dengue
- Interventions
- V181, Butantan - DV
- First posted
- 2023-02-02
- Last updated
- 2025-11-18
- Results first posted
- 2025-11-18
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Day 28 post-vaccination | A dengue VRNT was conducted to assess neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination |
| Primary | Percentage of Participants Who Seroconverted, as Measured by VRNT | Day 28 post-vaccination | A dengue VRNT was conducted to assess the percentage of participants who seroconverted for each of the 4 dengue serotypes (DENV-1, DENV-2, DENV-3 and DENV-4) at Day 28 post-vaccination. Seroconversion was defined as achieving a serotype-specific VRNT titer ≥lower limit of quantification (LLOQ) at Day 28 post-vaccination in the analysis population. |
| Primary | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | Up to 28 days post-vaccination | An SAE is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. |
| Secondary | Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) | Up to 5 days post-vaccination | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs included erythema (redness), pain, and swelling. |
| Secondary | Percentage of Participants Who Experience Solicited Systemic AEs | Up to 28 days post-vaccination | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), pyrexia (axillary temperature ≥37.8°C or 100°F), and rash. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Day 28 post-vaccination | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and with data available for this outcome. These deviations included seropositivity at baseline as assessed by VRNT and missing serological results. | Titer | GEOMETRIC_MEAN |
| PRIMARY | Percentage of Participants Who Seroconverted, as Measured by VRNT | Day 28 post-vaccination | All randomized participants without protocol deviations that could have substantially impacted the results of the immunogenicity analyses and with data available for this outcome. These deviations included seropositivity at baseline as assessed by VRNT and missing serology results. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | Up to 28 days post-vaccination | All randomized participants who received at least one dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) | Up to 5 days post-vaccination | All randomized participants who received at least one dose of study intervention. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experience Solicited Systemic AEs | Up to 28 days post-vaccination | All randomized participants who received at least one dose of study intervention. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | V181 | DENV-1 Serotype | 608.55 | 95% Confidence Interval 550.54 to 672.66 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Butantan-DV | DENV-1 Serotype | 703.19 | 95% Confidence Interval 642.56 to 769.53 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | V181 | DENV-2 Serotype | 773.96 | 95% Confidence Interval 711.16 to 842.30 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Butantan-DV | DENV-2 Serotype | 109.05 | 95% Confidence Interval 94.98 to 125.20 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | V181 | DENV-3 Serotype | 179.97 | 95% Confidence Interval 161.27 to 200.83 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Butantan-DV | DENV-3 Serotype | 396.76 | 95% Confidence Interval 357.92 to 439.81 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | V181 | DENV-4 Serotype | 206.58 | 95% Confidence Interval 180.71 to 236.16 | Titer |
| Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) | Butantan-DV | DENV-4 Serotype | 593.41 | 95% Confidence Interval 520.27 to 676.83 | Titer |
| Percentage of Participants Who Seroconverted, as Measured by VRNT | V181 | DENV-1 Serotype | 98.6 | percentage of participants | |
| Percentage of Participants Who Seroconverted, as Measured by VRNT | Butantan-DV | DENV-1 Serotype | 98.9 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | V181 | 682 | |
| Overall Study | STARTED | Butantan-DV | 682 | |
| Overall Study | Treated | V181 | 680 | |
| Overall Study | Treated | Butantan-DV | 678 | |
| Overall Study | COMPLETED | V181 | 660 | |
| Overall Study | COMPLETED | Butantan-DV | 665 | |
| Overall Study | NOT COMPLETED | V181 | 22 | |
| Overall Study | NOT COMPLETED | Butantan-DV | 17 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Eye Pain | Eye disorders | V181 | 32 | 680 | 32 |
| other | Eye Pain | Eye disorders | Butantan - DV | 40 | 678 | 42 |
| other | Nausea | Gastrointestinal disorders | V181 | 41 | 680 | 43 |
| other | Nausea | Gastrointestinal disorders | Butantan - DV | 36 | 678 | 38 |
| other | Fatigue | General disorders | V181 | 294 | 680 | 294 |
| other | Fatigue | General disorders | Butantan - DV | 311 | 678 | 312 |
| other | Injection site erythema | General disorders | V181 | 72 | 680 | 72 |
| other | Injection site erythema | General disorders | Butantan - DV | 45 | 678 | 45 |
| other | Injection site pain | General disorders | V181 | 121 | 680 | 121 |
| other | Injection site pain | General disorders | Butantan - DV | 124 | 678 | 124 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | V181 | 1 | 682 |
| Total, all-cause mortality | Butantan - DV | 0 | 682 |
| Total, other adverse events | V181 | 634 | 680 |
| Total, other adverse events | Butantan - DV | 622 | 678 |
| Total, serious adverse events | V181 | 12 | 680 |
| Total, serious adverse events | Butantan - DV | 9 | 678 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| V181 vs Butantan - DV: deaths from any cause | Trial comparisons |
| V181 vs Butantan - DV: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05710224
GET https://conductscience.org/api/trials/v1/NCT05710224/results?page=2