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Dengue DiseasePhase 2NCT05507450

Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)

A Phase 2 study testing V181 High-Potency Level, V181 Mid-Potency Level and V181 Low-Potency Level in people with Dengue Disease and Dengue Virus, run by Merck Sharp & Dohme LLC at 32 sites in 7 countries.

Completed

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

Official record
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Trial summary

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Dengue Disease, Dengue Virus
What is being tested?
V181 High-Potency Level, V181 Mid-Potency Level and V181 Low-Potency Level
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,271 participants
Where
32 sitesin 7 countries
Study dates
7 Sep 2022to 7 May 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 are eligible to participate if they agree to the following for at least 90 days after administration of study intervention: Abstain from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause).
  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is NOT women of child-bearing potential; or is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or is 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. (Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.)

Who cannot join

  • Has known history of dengue or zika natural infection.
  • Has an acute febrile illness (temperature ≥38.0°C [≥100.4°F] oral or equivalent) occurring within 72 hours before receipt of study vaccine or placebo.
  • Has a serious or progressive disease, including but not limited to cancer; uncontrolled diabetes; severe cardiac, renal, or hepatic insufficiency; or systemic autoimmune or neurologic disorder.
  • Has 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.
  • Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant, such as hemophilia, thrombocytopenia, other severe coagulation disorders, or significantly impaired venous access.
  • Has a known hypersensitivity to any component of the study vaccine or placebo, or history of severe allergic reaction (eg, swelling of the mouth and throat, difficulty breathing, hypotension or shock) that required medical intervention.
Show all 15Show fewer
  • Has received a dose of any dengue vaccine (investigational or approved) before study entry, or plans to receive any dengue vaccine (investigational or approved) for the duration of the trial.
  • Has received other licensed non-live vaccines within 14 days before receipt of study vaccine or placebo, or is scheduled to receive any licensed non-live vaccine within 28 days following receipt of study vaccine or placebo. Exception: Inactivated influenza vaccine may be administered but must be given at least 7 days before receipt of study vaccine or placebo, or at least 28 days after receipt of study vaccine or placebo.
  • Has received a licensed live vaccine within 28 days before receipt of study vaccine or placebo, or is scheduled to receive any live vaccine within 28 days following receipt of study vaccine or placebo.
  • Has received systemic corticosteroids (equivalent of ≥2 mg/kg/day of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry or is expected to receive systemic corticosteroids at aforementioned dose and duration within 28 days following receipt of study vaccine or placebo. (Note: Topical and inhaled/nebulized steroids are permitted.)
  • Has received systemic corticosteroids exceeding physiologic replacement doses (approximately 5 mg/day prednisone equivalent) within 14 days before vaccination.
  • Has 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 before receipt of study vaccine or placebo, or plans to receive immunosuppressive therapies within 28 days following receipt of study vaccine or placebo.
  • Has received a blood transfusion or blood products (including immunoglobulins) within 6 months before receipt of a study vaccine or placebo, or plans to receive a blood transfusion or blood products (including immunoglobulins) within 28 days following receipt of study vaccine or placebo.
  • Has participated in another clinical study of an investigational product within 6 months before signing the informed consent, or plans to participate in another interventional clinical study at any time during the duration of the current clinical study. Participants enrolled in observational studies may be included; these will be reviewed on a case-by-case basis for approval by the Sponsor.
  • Has planned donation of blood, eggs, or sperm at any time from signing the informed consent through 90 days post-vaccination.

Trial locations and contacts

32 sites in 7 countries.

32 sites in 7 countries

Finland9 sites

  • FVR, Espoon rokotetutkimusklinikka ( Site 0036)

    Espoo, Uusimaa, 02230

  • FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0038)

    Helsinki, Uusimaa, 00100

  • FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 0035)

    Helsinki, Uusimaa, 00930

  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0037)

    Kokkola, Keski-Pohjanmaa, 67100

  • FVR, Oulun rokotetutkimusklinikka ( Site 0032)

    Oulu, North Ostrobothnia, 90220

  • FVR, Porin rokotetutkimusklinikka ( Site 0033)

    Pori, Satakunta, 28100

  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0040)

    Seinäjoki, South Ostrobothnia, 60100

  • FVR, Tampereen rokotetutkimusklinikka ( Site 0039)

    Tampere, Pirkanmaa, 33100

  • FVR, Turun rokotetutkimusklinikka ( Site 0031)

    Turku, Southwest Finland, 20520

Other trials in Finland

United States6 sites

  • University of Texas Medical Branch ( Site 0113)

    Galveston, Texas, 77555

  • Advanced Medical Research Institute ( Site 0115)

    Miami, Florida, 33174

  • Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0123)

    Norfolk, Virginia, 23502

  • Rochester Clinical Research, Inc. ( Site 0122)

    Rochester, New York, 14609

  • IMA Clinical Research San Antonio ( Site 0111)

    San Antonio, Texas, 78229

  • California Research Foundation ( Site 0114)

    San Diego, California, 92123

Other trials in United States

Australia6 sites

  • Paratus Clinical Research Western Sydney ( Site 0007)

    Blacktown, New South Wales, 2148

  • Emeritus Research ( Site 0010)

    Botany, New South Wales, 2019

  • Emeritus Research ( Site 0009)

    Camberwell, Victoria, 3124

  • USC Clinical Trials Moreton Bay ( Site 0001)

    Morayfield, Queensland, 4506

  • USC Clinical Trials Sunshine Coast ( Site 0005)

    Sippy Downs, Queensland, 4556

  • USC Clinical Trials Brisbane (South Bank) ( Site 0006)

    South Brisbane, Queensland, 4101

Other trials in Australia

Canada4 sites

  • Diex Recherche Quebec Inc. ( Site 0022)

    Québec, Quebec, G1V 4T3

  • Diex Recherche Joliette ( Site 0023)

    Saint-Charles-Borromée, Quebec, J6E 2B4

  • Diex Recherche Sherbrooke Inc. ( Site 0024)

    Sherbrooke, Quebec, J1L 0H8

  • Diex Recherche Victoriavile Inc. ( Site 0021)

    Victoriaville, Quebec, G6P 6P6

Other trials in Canada

Germany3 sites

  • Berliner Centrum für Reise- und Tropenmedizin ( Site 0043)

    Berlin, 10117

  • Bernhard Nocht Institute for Tropical Medicine ( Site 0041)

    Hamburg, 20359

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Division of Infectious Diseases and Tropical (

    München, Bavaria, 80802

Other trials in Germany

Israel3 sites

  • Rambam Health Care Campus-Oncology ( Site 0053)

    Haifa, 3109601

  • Hadassah Medical Center-Clinical Reaserch Unit ( Site 0052)

    Jerusalem, 9112001

  • Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0051)

    Ramat Gan, 5265601

Other trials in Israel

Taiwan1 site

  • Kaohsiung Medical University Hospital-Infectious diseases Division, Department of Internal Medicine

    Kaohsiung City, 807

Other trials in Taiwan

About this study

Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Three Different Potency Levels of V181 (Dengue Quadrivalent Vaccine rDENVΔ30 [Live, Attenuated]) in Healthy Adults

The primary objective of this study is to compare the dengue virus-neutralizing antibody geometric mean titers (GMTs) for each of the 4 dengue serotypes (DENV1, DENV2, DENV3, and DENV4) at Day 28 post-vaccination for participants administered the V181 Low-Potency Level vaccine versus the V181 Mid-Potency Level vaccine. This study will also evaluate the safety and tolerability of 3 different V181 potency level vaccines. The primary hypothesis of the study is that the V181 Low-Potency Level vaccine is non-inferior to the V181 Mid-Potency Level vaccine for each of the 4 dengue serotypes based on GMTs at Day 28 post-vaccination.

Being tested
V181 High-Potency Level, V181 Mid-Potency Level, V181 Low-Potency Level, Placebo

What participants receive

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

  • V181 High-Potency LevelBiological

    0.5 mL SC dose of V181 High-Potency vaccine

  • V181 Mid-Potency LevelBiological

    0.5 mL SC dose of V181 Mid-Potency vaccine

  • V181 Low-Potency LevelBiological

    0.5 mL SC dose of V181 Low-Potency vaccine

  • PlaceboBiological

    0.5 mL SC dose of placebo

Study groups in NCT05507450
Study groupRoleWhat they receive
V181 High-Potency Level GroupExperimentalParticipants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine.
Receives: Biological: V181 High-Potency Level
V181 Mid-Potency Level GroupExperimentalParticipants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine.
Receives: Biological: V181 Mid-Potency Level
V181 Low-Potency Level GroupExperimentalParticipants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine.
Receives: Biological: V181 Low-Potency Level
PlaceboPlacebo comparatorParticipants will receive a single SC 0.5 mL dose of placebo.
Receives: Biological: Placebo

What is being measured

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

  1. Dengue Virus-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 vaccine serotypes (DENV1, DENV2, DENV3, and DENV4) in specimens collected from participants on Day 28 post-vaccination.

    Measured: Day 28 post-vaccination

  2. 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 will be determined by the investigator.

    Measured: Up to 28 days post-vaccination

Secondary outcomes (2)

  1. Percentage of Participants With Solicited Injection-Site Adverse Events (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 injection-site AEs include pain, erythema (redness), and swelling.

    Measured: Up to 5 days post-vaccination

  2. Percentage of Participants With 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 rash, headache, fatigue (tiredness), pyrexia (oral temperature ≥100.4 °F or 38.0 °C), myalgia (muscle pain), and arthralgia (joint pain).

    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.

  1. First posted19 Aug 2022
  2. Study start7 Sep 2022
  3. Primary completion5 Jun 2023
  4. Study completion7 May 2024

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
1,271 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05507450
Sponsor's protocol ID
V181-003
Other IDs
V181-003, 2020-004501-30
Status last verified
Apr 2025
First submitted
17 Aug 2022
Last updated
9 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing V181 High-Potency Level, V181 Mid-Potency Level and V181 Low-Potency Level in people with Dengue Disease and Dengue Virus, run by Merck Sharp & Dohme LLC at 32 sites in 7 countries.

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 2 inclusion and 15 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 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in Finland, United States, Australia, Canada, Germany and 2 more countries. 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. Some participants in this study may receive a placebo. 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 9 May 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-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT) (time frame: Day 28 post-vaccination). The study lists 2 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 NCT05507450.

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 9 May 2025.

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