Clinical trial NCT05507450: Safety and Immunogenicity of Three V181 Dengue Vaccine Potencies in Adults (V181-003)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dengue Disease
Dengue Virus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-08-19
Enrollment: 1271
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Dengue Virus-Neutralizing Antibody Titers, as Measured by Virus Reduction Neutralization Test (VRNT)
timeFrame: Day 28 post-vaccination
measure: Percentage of Participants With Vaccine-Related Serious Adverse Events (SAEs)
timeFrame: Up to 28 days post-vaccination
Secondary outcomes:
measure: Percentage of Participants With Solicited Injection-Site Adverse Events (AEs)
timeFrame: Up to 5 days post-vaccination
measure: Percentage of Participants With Solicited Systemic AEs
timeFrame: Up to 28 days post-vaccination
Other outcomes:
Locations:
city: San Diego
country: United States
facility: California Research Foundation ( Site 0114)
state: California
city: Miami
country: United States
facility: Advanced Medical Research Institute ( Site 0115)
state: Florida
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc. ( Site 0122)
state: New York
city: Galveston
country: United States
facility: University of Texas Medical Branch ( Site 0113)
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio ( Site 0111)
state: Texas
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research LLC (AMR - Norfolk) ( Site 0123)
state: Virginia
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney ( Site 0007)
state: New South Wales
city: Botany
country: Australia
facility: Emeritus Research ( Site 0010)
state: New South Wales
city: Morayfield
country: Australia
facility: USC Clinical Trials Moreton Bay ( Site 0001)
state: Queensland
city: Sippy Downs
country: Australia
facility: USC Clinical Trials Sunshine Coast ( Site 0005)
state: Queensland
city: South Brisbane
country: Australia
facility: USC Clinical Trials Brisbane (South Bank) ( Site 0006)
state: Queensland
city: Camberwell
country: Australia
facility: Emeritus Research ( Site 0009)
state: Victoria
city: Saint-Charles-Borromée
country: Canada
facility: Diex Recherche Joliette ( Site 0023)
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke Inc. ( Site 0024)
state: Quebec
city: Victoriaville
country: Canada
facility: Diex Recherche Victoriavile Inc. ( Site 0021)
state: Quebec
city: Quebec
country: Canada
facility: Diex Recherche Quebec Inc. ( Site 0022)
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 0037)
state: Mellersta Osterbotten
city: Tampere
country: Finland
facility: FVR, Tampereen rokotetutkimusklinikka ( Site 0039)
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka ( Site 0032)
state: Pohjois-Pohjanmaa
city: Pori
country: Finland
facility: FVR, Porin rokotetutkimusklinikka ( Site 0033)
state: Satakunta
city: Seinajoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0040)
state: Sodra Osterbotten
city: Espoo
country: Finland
facility: FVR, Espoon rokotetutkimusklinikka ( Site 0036)
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0038)
state: Uusimaa
city: Helsinki
country: Finland
facility: FVR, Itä-Helsingin rokotetutkimusklinikka ( Site 0035)
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka ( Site 0031)
state: Varsinais-Suomi
city: München
country: Germany
facility: Klinikum der Ludwig-Maximilians-Universitaet Muenchen-Division of Infectious Diseases and Tropical (
state: Bayern
city: Berlin
country: Germany
facility: Berliner Centrum für Reise- und Tropenmedizin ( Site 0043)
city: Hamburg
country: Germany
facility: Bernhard Nocht Institute for Tropical Medicine ( Site 0041)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 0053)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Clinical Reaserch Unit ( Site 0052)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0051)
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital-Infectious diseases Division, Department of Internal Medicine
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: