Trial Outcomes & Findings for 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 NCT05710224)

Last Updated: 2025-11-18

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1364 participants

Primary outcome timeframe

Day 28 post-vaccination

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	V181 Participants received a single 0.5 mL subcutaneous (SC) injection of V181 .	Butantan-DV Participants received a single 0.5 mL SC injection of Butantan - DV.
Overall Study STARTED	682	682
Overall Study Treated	680	678
Overall Study COMPLETED	660	665
Overall Study NOT COMPLETED	22	17

Reasons for withdrawal

Reasons for withdrawal
Measure	V181 Participants received a single 0.5 mL subcutaneous (SC) injection of V181 .	Butantan-DV Participants received a single 0.5 mL SC injection of Butantan - DV.
Overall Study Death	1	0
Overall Study Lost to Follow-up	16	7
Overall Study Withdrawal by Subject	4	6
Overall Study Randomized By Mistake Without Study Treatment	1	2
Overall Study Participants Left The City	0	2

Baseline Characteristics

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)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V181 n=682 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.	Butantan - DV n=682 Participants Participants received a single 0.5 mL SC injection of Butantan - DV.	Total n=1364 Participants Total of all reporting groups
Age, Continuous	32.8 years STANDARD_DEVIATION 8.9 • n=39 Participants	32.2 years STANDARD_DEVIATION 9.0 • n=29 Participants	32.5 years STANDARD_DEVIATION 9.0 • n=60 Participants
Sex/Gender, Customized Male	222 Participants n=39 Participants	257 Participants n=29 Participants	479 Participants n=60 Participants
Sex/Gender, Customized Female	459 Participants n=39 Participants	425 Participants n=29 Participants	884 Participants n=60 Participants
Sex/Gender, Customized Undifferentiated	1 Participants n=39 Participants	0 Participants n=29 Participants	1 Participants n=60 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	569 Participants n=39 Participants	575 Participants n=29 Participants	1144 Participants n=60 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	99 Participants n=39 Participants	92 Participants n=29 Participants	191 Participants n=60 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	14 Participants n=39 Participants	15 Participants n=29 Participants	29 Participants n=60 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=39 Participants	2 Participants n=29 Participants	6 Participants n=60 Participants
Race (NIH/OMB) Asian	3 Participants n=39 Participants	2 Participants n=29 Participants	5 Participants n=60 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=29 Participants	0 Participants n=60 Participants
Race (NIH/OMB) Black or African American	70 Participants n=39 Participants	71 Participants n=29 Participants	141 Participants n=60 Participants
Race (NIH/OMB) White	585 Participants n=39 Participants	579 Participants n=29 Participants	1164 Participants n=60 Participants
Race (NIH/OMB) More than one race	20 Participants n=39 Participants	27 Participants n=29 Participants	47 Participants n=60 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=39 Participants	1 Participants n=29 Participants	1 Participants n=60 Participants

PRIMARY outcome

Timeframe: Day 28 post-vaccination

Population: 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.

Outcome measures

Outcome measures
Measure	Butantan-DV n=531 Participants Participants received a single 0.5 mL SC injection of Butantan-DV.	V181 n=514 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) DENV-1 Serotype	703.19 Titer Interval 642.56 to 769.53	608.55 Titer Interval 550.54 to 672.66
Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) DENV-2 Serotype	109.05 Titer Interval 94.98 to 125.2	773.96 Titer Interval 711.16 to 842.3
Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) DENV-3 Serotype	396.76 Titer Interval 357.92 to 439.81	179.97 Titer Interval 161.27 to 200.83
Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) DENV-4 Serotype	593.41 Titer Interval 520.27 to 676.83	206.58 Titer Interval 180.71 to 236.16

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Butantan-DV n=531 Participants Participants received a single 0.5 mL SC injection of Butantan-DV.	V181 n=514 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Percentage of Participants Who Seroconverted, as Measured by VRNT DENV-1 Serotype	98.9 percentage of participants	98.6 percentage of participants
Percentage of Participants Who Seroconverted, as Measured by VRNT DENV-2 Serotype	84.2 percentage of participants	99.2 percentage of participants
Percentage of Participants Who Seroconverted, as Measured by VRNT DENV-3 Serotype	98.9 percentage of participants	95.3 percentage of participants
Percentage of Participants Who Seroconverted, as Measured by VRNT DENV-4 Serotype	95.9 percentage of participants	92.2 percentage of participants

PRIMARY outcome

Timeframe: Up to 28 days post-vaccination

Population: All randomized participants who received at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Butantan-DV n=678 Participants Participants received a single 0.5 mL SC injection of Butantan-DV.	V181 n=680 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Up to 5 days post-vaccination

Population: All randomized participants who received at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Butantan-DV n=678 Participants Participants received a single 0.5 mL SC injection of Butantan-DV.	V181 n=680 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) Injection-site erythema	6.0 percentage of participants	10.3 percentage of participants
Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) Injection-site pain	17.8 percentage of participants	17.6 percentage of participants
Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs) Injection-site swelling	2.2 percentage of participants	2.8 percentage of participants

SECONDARY outcome

Timeframe: Up to 28 days post-vaccination

Population: All randomized participants who received at least one dose of study intervention.

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.

Outcome measures

Outcome measures
Measure	Butantan-DV n=678 Participants Participants received a single 0.5 mL SC injection of Butantan-DV.	V181 n=680 Participants Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Percentage of Participants Who Experience Solicited Systemic AEs Fatigue	46.8 percentage of participants	44.6 percentage of participants
Percentage of Participants Who Experience Solicited Systemic AEs Headache	67.7 percentage of participants	64.6 percentage of participants
Percentage of Participants Who Experience Solicited Systemic AEs Myalgia	45.1 percentage of participants	37.2 percentage of participants
Percentage of Participants Who Experience Solicited Systemic AEs Pyrexia	10.8 percentage of participants	5.6 percentage of participants
Percentage of Participants Who Experience Solicited Systemic AEs Rash	63.7 percentage of participants	70.6 percentage of participants
Percentage of Participants Who Experience Solicited Systemic AEs Arthralgia	22.1 percentage of participants	21.0 percentage of participants

Adverse Events

V181

Serious events: 12 serious events

Other events: 634 other events

Deaths: 1 deaths

Butantan - DV

Serious events: 9 serious events

Other events: 622 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V181 n=680 participants at risk Participants received a single 0.5 mL SC injection of V181.	Butantan - DV n=678 participants at risk Participants received a single 0.5 mL SC injection of Butantan - DV.
Eye disorders Eye Pain	4.7% 32/680 • Number of events 32 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	5.9% 40/678 • Number of events 42 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Nausea	6.0% 41/680 • Number of events 43 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	5.3% 36/678 • Number of events 38 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
General disorders Fatigue	43.2% 294/680 • Number of events 294 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	45.9% 311/678 • Number of events 312 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
General disorders Injection site erythema	10.6% 72/680 • Number of events 72 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	6.6% 45/678 • Number of events 45 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
General disorders Injection site pain	17.8% 121/680 • Number of events 121 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	18.3% 124/678 • Number of events 124 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
General disorders Pyrexia	6.8% 46/680 • Number of events 49 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	13.6% 92/678 • Number of events 101 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Arthralgia	20.4% 139/680 • Number of events 141 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	21.7% 147/678 • Number of events 149 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Pruritus	8.4% 57/680 • Number of events 57 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	9.9% 67/678 • Number of events 70 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Skin and subcutaneous tissue disorders Rash	70.6% 480/680 • Number of events 482 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	63.7% 432/678 • Number of events 435 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Musculoskeletal and connective tissue disorders Myalgia	35.6% 242/680 • Number of events 242 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	43.4% 294/678 • Number of events 297 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Nervous system disorders Headache	61.9% 421/680 • Number of events 429 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	65.0% 441/678 • Number of events 443 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.

Additional Information

Fernanda Castro Boulos - Diretoria Médica, Centro de Ensaios Clínicos e Farmacovigilância

Instituto Butantan

Phone: +55 11 3723-6797

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor and Merck Sharp \& Dohme LLC (MSD), the investigator agrees to submit all manuscripts or abstracts to the Sponsor and MSD before submission. This allows the Sponsor and MSD to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER

Measure	V181 n=680 participants at risk Participants received a single 0.5 mL SC injection of V181.	Butantan - DV n=678 participants at risk Participants received a single 0.5 mL SC injection of Butantan - DV.
Gastrointestinal disorders Abdominal pain	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Gastrointestinal disorders Pancreatitis acute	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
General disorders Death	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Immune system disorders Anaphylactic reaction	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Infections and infestations Dengue fever	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Infections and infestations Hepatitis A	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Infections and infestations Osteomyelitis	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Infections and infestations Pyoderma	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Femoral neck fracture	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Limb injury	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Injury, poisoning and procedural complications Meniscus injury	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Nervous system disorders Intracranial hypotension	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Alcoholism	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Anxiety	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Depression	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Mental disorder	0.00% 0/680 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.15% 1/678 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Suicidal ideation	0.15% 1/680 • Number of events 2 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Psychiatric disorders Suicide attempt	0.29% 2/680 • Number of events 2 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.
Renal and urinary disorders Nephrolithiasis	0.15% 1/680 • Number of events 1 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.	0.00% 0/678 • Up to ~20 months All-cause mortality: All randomized participants; AEs: All randomized participants who received at least one dose of study intervention.