DenguePhase 2NCT05710224

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)

A Phase 2 study testing V181 and Butantan - DV in people with Dengue, run by Butantan Institute at 14 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Dengue
What is being tested?: V181 and Butantan - DV
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,364 participants
Where: 14 sitesBrazil
Study dates: 15 Feb 2023to 12 Dec 2024
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Male participants were eligible to participate if they agreed to the following for at least 90 days after administration of study intervention:
Abstained from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agreed to remain abstinent; or agreed to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
A female participant was eligible to participate if she was not pregnant or breastfeeding, and at least one of the following conditions applies:
was NOT a woman of child-bearing potential (WOCBP); or
was a WOCBP and using a contraceptive a highly effective method (with a failure rate of <1% per year), or
was abstinent from heterosexual intercourse as her preferred and usual lifestyle (abstinent on a long term and persistent basis), for at least 90 days after administration of study intervention.
Had a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) before administration of study intervention
Were dengue seronegative based on a pre-vaccination point of care (POC) dengue test.

Who cannot join

Had a known history of dengue or Zika natural infection.
Had an acute febrile illness (axillary temperature ≥37.8°C) occurring within 72 hours prior to receipt of study vaccine.
Had a known hypersensitivity or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) to any component of the dengue vaccine, that required medical intervention.
Had a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, systemic autoimmune or neurologic disorder.
Had known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, hematologic malignancy, or treatment for autoimmune diseases.
Had a condition in which repeated venipuncture or injections pose more than minimal risk, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access

Show all 14Show fewer

Had received a dose of any dengue vaccine (investigational or approved) prior to study entry or plans to receive any dengue vaccine (investigational or approved) for trial duration.
Had received a licensed non-live vaccine within 14 days before receipt of study vaccine or was scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine. Exception: Inactivated influenza vaccine might be administered, but given at least 7 days before receipt of study vaccine or at least 28 days after receipt of study vaccine.
Had received a licensed live vaccine within 28 days prior to receipt of study vaccine or was scheduled to receive any live vaccine within 28 days following receipt of study vaccine.
Had received systemic corticosteroids (equivalent of ≥2 mg/kg/day of prednisone or ≥20 mg/day for persons weighing >10 kg) for ≥14 consecutive days and had not completed treatment at least 30 days before study entry or was expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine. (Note: topical and inhaled/nebulized steroids were permitted.)
Had received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
Had received immunosuppressive therapies, including chemotherapeutic agents used to treat cancer or other conditions, treatments associated with organ or bone marrow transplantation, or autoimmune disease, within 6 months prior to receipt of study vaccine, or plans to receive immunosuppressive therapies within 28 days following receipt of study vaccine.
Had received a blood transfusion or blood products (including immunoglobulins) within 6 months prior to receipt of study vaccine or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days following receipt of study vaccine.
Had planned donation of blood, eggs, or sperm at any time from signing the informed consent through 90 days post-vaccination.

Trial locations and contacts

14 sites in 1 country.

City, postcode or hospital

14 sites in 1 country

Brazil14 sites

Hospital Tacchini (Site 0006)
Bento Gonçalves, Rio Grande do Sul, 95700084
Fundação Universidade de Caxias do Sul (FUCS) - Instituto de Pesquisas em Saúde (IPS) (Site 0017)
Caxias do Sul, Rio Grande do Sul, 95070560
Clínica Supera (Site 0019)
Chapecó, Santa Catarina, 89812-211
ONCOSITE - Centro de Pesquisa Clinica em Oncologia (Site 0005)
Ijuí, Rio Grande do Sul, 98700-000
Hospital São Vicente de Paulo-Education and Research Management (Site 0007)
Passo Fundo, Rio Grande do Sul, 99010-080
Instituto Méderi de Pesquisa e Saúde (0020)
Passo Fundo, Rio Grande do Sul, 99010-120
Criciuma (Site 0008)
Passo Fundo, Santa Catarina, 88811508
Hospital Escola da Universidade Federal de Pelotas (Site 0009)
Pelotas, Rio Grande do Sul, 96020-360
Irmandade da Santa Casa de Misericórdia de Porto Alegre-Centro de Pesquisa em Infectologia (Site # 003)
Porto Alegre, Rio Grande do Sul, 90020-090
Núcleo de Pesquisa Clínica do Rio Grande do Sul (Site 0011)
Porto Alegre, Rio Grande do Sul, 90430-001
LMK Serviços Médicos S/S-Reumacenter (Site 0004)
Porto Alegre, Rio Grande do Sul, 90480-000
Hospital Moinhos de Vento - Centro de Pesquisa Clínica (Site0021)
Porto Alegre, Rio Grande do Sul, 90560-030
Hospital São Lucas da PUCRS-Centro de Pesquisa Clínica HSL-PUCRS (Site 0015)
Porto Alegre, Rio Grande do Sul, 90610-000
Universidade Federal de Santa Maria (UFSM) - Hospital Univer-Unidade de Pesquisa Clínica-UPC (Site 0001)
Santa Maria, Rio Grande do Sul, 97105-900

Other trials in Brazil

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil

The purpose of this study was to demonstrate that V181 is safe and well tolerated and elicits an immune response that is non-inferior to that of Butantan - DV at Day 28 post-vaccination in adults 18 to 50 years of age in Brazil. The primary hypothesis was that V181 is non-inferior to Butantan - DV for each of the 4 dengue serotypes based on geometric mean titers (GMTs) and seroconversion rates at Day 28 post-vaccination.

Conditions: Dengue
Being tested: V181, Butantan - DV
Medical subject headings: Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

V181Biological
0.5 mL SC dose of V181
Butantan - DVBiological
0.5 mL SC dose of Butantan - DV

Study groups in NCT05710224
Study group	Role	What they receive
V181	Experimental	Participants received a single 0.5 mL subcutaneous (SC) injection of V181. Receives: Biological: V181
Butantan - DV	Experimental	Participants received a single 0.5 mL SC injection of Butantan - DV. Receives: Biological: Butantan - DV

What is being measured

The primary outcome is the main question the study is designed to answer.

Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT)
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
Measured: Day 28 post-vaccination
Percentage of Participants Who Seroconverted, as Measured by VRNT
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.
Measured: Day 28 post-vaccination
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
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.
Measured: Up to 28 days post-vaccination

Secondary outcomes (2)

Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs)
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.
Measured: Up to 5 days post-vaccination
Percentage of Participants Who Experience Solicited Systemic AEs
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.
Measured: Up to 28 days post-vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202312 Dec 2024

First posted2 Feb 2023
Study start15 Feb 2023
Primary completion22 Jan 2024
Study completion12 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 1,364 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05710224
Sponsor's protocol ID: V181- 002
Other IDs: 25351.019896/2021- 84
Status last verified: Nov 2025
First submitted: 24 Jan 2023
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

Alexanderian D, Ramos F, Chatterjee S, Schwarzbold AV, Loch AP, Zanetti ACB, Chen Q, Martin J, Onorato MT, Anez G. Safety and Immunogenicity of the Live-Attenuated Quadrivalent Dengue Vaccine V181 Compared With Butantan-DV Among Healthy Adults in Brazil: A Randomized, Double-Blind, Phase 2 Trial. Clin Infect Dis. 2026 Jul 1:ciag349. doi: 10.1093/cid/ciag349. Online ahead of print.
PubMed 42383822
Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21.
PubMed 42253092

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs

All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Safety and Immunogenicity Clinical Bridging Study to Compare V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) to Butantan Dengue Vaccine (Butantan - DV) in Healthy Adults 18 to 50 Years of Age in Brazil
ClinicalTrials.gov ID: NCT05710224
Acronym / sponsor ID: V181- 002
Conditions: Dengue
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,364 participants (actual)
Lead sponsor: Butantan InstituteOther government
Collaborators: Merck Sharp & Dohme LLC
Study start: 15 Feb 2023 (actual)
Primary completion: 22 Jan 2024 (actual)
Study completion: 12 Dec 2024 (actual)
First posted: 2 Feb 2023 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
V181	Experimental	Biological: V181Participants received a single 0.5 mL subcutaneous (SC) injection of V181.
Butantan - DV	Experimental	Biological: Butantan - DVParticipants received a single 0.5 mL SC injection of Butantan - DV.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Male participants were eligible to participate if they agreed to the following for at least 90 days after administration of study intervention:
A female participant was eligible to participate if she was not pregnant or breastfeeding, and at least one of the following conditions applies:
Were dengue seronegative based on a pre-vaccination point of care (POC) dengue test.

Key exclusion criteria (14 listed)

Had a known history of dengue or Zika natural infection.
Had an acute febrile illness (axillary temperature ≥37.8°C) occurring within 72 hours prior to receipt of study vaccine.
Had a known hypersensitivity or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) to any component of the dengue vaccine, that required medical intervention.
Had a serious or progressive disease, including but not limited to cancer, uncontrolled diabetes, severe cardiac, renal or hepatic insufficiency, systemic autoimmune or neurologic disorder.
Had known or suspected impairment of immunological function, including but not limited to congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, hematologic malignancy, or treatment for autoimmune diseases.

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
V1810.5 mL SC dose of V181	Biological	V181
Butantan - DV0.5 mL SC dose of Butantan - DV	Biological	Butantan - DV

Primary outcome

Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT)
Time frame: 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
Percentage of Participants Who Seroconverted, as Measured by VRNT
Time frame: 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.
Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)
Time frame: 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.

2 secondary outcomes

Percentage of Participants Who Experience Solicited Injection-site Adverse Events (AEs)
Time frame: Up to 5 days post-vaccination
Percentage of Participants Who Experience Solicited Systemic AEs
Time frame: Up to 28 days post-vaccination

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
V181	682	660
Butantan-DV	682	665

Primary outcome: Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT)

Time frame: Day 28 post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titer

Measure	V181 n = 514	Butantan-DV n = 531
DENV-1 Serotype	608.55 (550.54 to 672.66)	703.19 (642.56 to 769.53)
DENV-2 Serotype	773.96 (711.16 to 842.30)	109.05 (94.98 to 125.20)
DENV-3 Serotype	179.97 (161.27 to 200.83)	396.76 (357.92 to 439.81)
DENV-4 Serotype	206.58 (180.71 to 236.16)	593.41 (520.27 to 676.83)

V181 vs Butantan-DV: GMT Ratio: 0.87 (95% CI 0.76 to 0.99), p <0.001, t-distribution
V181 vs Butantan-DV: GMT Ratio: 7.10 (95% CI 6.03 to 8.35), p <0.001, t-distribution
V181 vs Butantan-DV: GMT Ratio: 0.45 (95% CI 0.39 to 0.53), p = 1.000, t- distribution

Population analysed: 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.

Primary outcome: Percentage of Participants Who Seroconverted, as Measured by VRNT

Time frame: Day 28 post-vaccination. Number. Unit: percentage of participants

Measure	V181 n = 514	Butantan-DV n = 531
DENV-1 Serotype	98.6	98.9
DENV-2 Serotype	99.2	84.2
DENV-3 Serotype	95.3	98.9
DENV-4 Serotype	92.2	95.9

V181 vs Butantan-DV: Difference in Percentage: -0.2 (95% CI -1.8 to 1.3), p <0.001, Miettinen & Nurminen method
V181 vs Butantan-DV: Difference in Percentage: 15.0 (95% CI 12.0 to 18.5), p <0.001, Miettinen & Nurminen method
V181 vs Butantan-DV: Difference in percentage: -3.5 (95% CI -5.8 to -1.6), p <0.001, Miettinen & Nurminen method

Primary outcome: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

Time frame: Up to 28 days post-vaccination. Number. Unit: percentage of participants

Measure	V181 n = 680	Butantan-DV n = 678
Value	0.0	0.0

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to ~20 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
V181	12 of 680 (1.8%)	634 of 680 (93.2%)	1 of 682
Butantan - DV	9 of 678 (1.3%)	622 of 678 (91.7%)	0 of 682

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42383822Alexanderian D, Ramos F, Chatterjee S, Schwarzbold AV, Loch AP, Zanetti ACB, Chen Q, Martin J, Onorato MT, Anez G. Safety and Immunogenicity of the Live-Attenuated Quadrivalent Dengue Vaccine V181 Compared With Butantan-DV Among Healthy Adults in Brazil: A Randomized, Double-Blind, Phase 2 Trial. Clin Infect Dis. 2026 Jul 1:ciag349. doi: 10.1093/cid/ciag349. Online ahead of print.
Derived from this study: PubMed 42253092Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21.
Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Related trials for Dengue

Active, not recruitingPhase 3
A Study to Evaluate V181 Dengue Vaccine in Healthy Participants 2 to 17 Years of Age (V181-005/MOBILIZE-1)
Healthy
RecruitingPhase 1
Phase 1 Challenge Study Using rDEN2delta30-7169 to Evaluate Host-Pathogen Interactions in Primary, Homotypic, and Heterotypic Dengue Virus Infection
Healthy Volunteers, Dengue
Active, not recruiting
A Controlled Human Infection Model of Dengue
Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs

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.

The record lists no contact. Use the official record to reach the sponsor.

14 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V181 and Butantan - DV in people with Dengue, run by Butantan Institute at 14 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 8 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Dengue Virus (DENV)-Neutralizing Antibody Titers as Measured by Virus Reduction Neutralization Test (VRNT) (time frame: Day 28 post-vaccination). The study lists 3 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 NCT05710224, which also lists 2 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 18 Nov 2025.