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

NCT ID: NCT05507450

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1271 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-07
• Study Completion Date: 2024-05-07

Brief 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 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.

Conditions

Dengue Disease; Dengue Virus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

V181 High-Potency Level Group

Participants will receive a single 0.5mL subcutaneous (SC) dose of V181 High-Potency vaccine.

Group Type: EXPERIMENTAL

V181 High-Potency Level

Intervention Type: BIOLOGICAL

0.5 mL SC dose of V181 High-Potency vaccine

V181 Mid-Potency Level Group

Participants will receive a single 0.5mL SC dose of V181 Mid-Potency vaccine.

Group Type: EXPERIMENTAL

V181 Mid-Potency Level

Intervention Type: BIOLOGICAL

0.5 mL SC dose of V181 Mid-Potency vaccine

V181 Low-Potency Level Group

Participants will receive a single 0.5mL SC dose of V181 Low-Potency vaccine.

Group Type: EXPERIMENTAL

V181 Low-Potency Level

Intervention Type: BIOLOGICAL

0.5 mL SC dose of V181 Low-Potency vaccine

Placebo

Participants will receive a single SC 0.5 mL dose of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: BIOLOGICAL

0.5 mL SC dose of placebo

Interventions

V181 High-Potency Level

0.5 mL SC dose of V181 High-Potency vaccine

Intervention Type: BIOLOGICAL

V181 Mid-Potency Level

0.5 mL SC dose of V181 Mid-Potency vaccine

Intervention Type: BIOLOGICAL

V181 Low-Potency Level

0.5 mL SC dose of V181 Low-Potency vaccine

Intervention Type: BIOLOGICAL

Placebo

0.5 mL SC dose of placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.)

Exclusion Criteria

• 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

California Research Foundation ( Site 0114)

San Diego, California, United States

Advanced Medical Research Institute ( Site 0115)

Miami, Florida, United States

Rochester Clinical Research, Inc. ( Site 0122)

Rochester, New York, United States

University of Texas Medical Branch ( Site 0113)

Galveston, Texas, United States

IMA Clinical Research San Antonio ( Site 0111)

San Antonio, Texas, United States

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

Norfolk, Virginia, United States

Paratus Clinical Research Western Sydney ( Site 0007)

Blacktown, New South Wales, Australia

Emeritus Research ( Site 0010)

Botany, New South Wales, Australia

USC Clinical Trials Moreton Bay ( Site 0001)

Morayfield, Queensland, Australia

USC Clinical Trials Sunshine Coast ( Site 0005)

Sippy Downs, Queensland, Australia

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

South Brisbane, Queensland, Australia

Emeritus Research ( Site 0009)

Camberwell, Victoria, Australia

Diex Recherche Quebec Inc. ( Site 0022)

Québec, Quebec, Canada

Diex Recherche Joliette ( Site 0023)

Saint-Charles-Borromée, Quebec, Canada

Diex Recherche Sherbrooke Inc. ( Site 0024)

Sherbrooke, Quebec, Canada

Diex Recherche Victoriavile Inc. ( Site 0021)

Victoriaville, Quebec, Canada

FVR, Kokkolan rokotetutkimusklinikka ( Site 0037)

Kokkola, Keski-Pohjanmaa, Finland

FVR, Oulun rokotetutkimusklinikka ( Site 0032)

Oulu, North Ostrobothnia, Finland

FVR, Tampereen rokotetutkimusklinikka ( Site 0039)

Tampere, Pirkanmaa, Finland

FVR, Porin rokotetutkimusklinikka ( Site 0033)

Pori, Satakunta, Finland

FVR, Seinäjoen rokotetutkimusklinikka ( Site 0040)

Seinäjoki, South Ostrobothnia, Finland

FVR, Turun rokotetutkimusklinikka ( Site 0031)

Turku, Southwest Finland, Finland

FVR, Espoon rokotetutkimusklinikka ( Site 0036)

Espoo, Uusimaa, Finland

FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0038)

Helsinki, Uusimaa, Finland

FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 0035)

Helsinki, Uusimaa, Finland

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

München, Bavaria, Germany

Berliner Centrum für Reise- und Tropenmedizin ( Site 0043)

Berlin, , Germany

Bernhard Nocht Institute for Tropical Medicine ( Site 0041)

Hamburg, , Germany

Rambam Health Care Campus-Oncology ( Site 0053)

Haifa, , Israel

Hadassah Medical Center-Clinical Reaserch Unit ( Site 0052)

Jerusalem, , Israel

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

Ramat Gan, , Israel

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

Kaohsiung City, , Taiwan

Countries

United States; Australia; Canada; Finland; Germany; Israel; Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

V181-003

Identifier Type: OTHER

Identifier Source: secondary_id

2020-004501-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V181-003

Identifier Type: -

Identifier Source: org_study_id