A Study of JNJ-64281802 for the Prevention of Dengue Infection
NCT ID: NCT05201794
Last Updated: 2025-07-31
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
1595 participants
INTERVENTIONAL
2023-02-22
2024-06-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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High-dose JNJ-64281802 regimen (HDR)
Participants will receive JNJ-64281802 400 milligrams (mg) loading dose (LD) twice daily for 48 hours (2 days), followed by JNJ-64281802 150 mg maintenance dose (MD) once daily for 26 days in fed conditions.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Low-dose JNJ-64281802 regimen (LDR)
Participants will receive JNJ-64281802 150 mg LD twice daily for 48 hours (2 days), followed by JNJ-64281802 50 mg MD once daily for 26 days in fed conditions.
JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Placebo
Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.
Placebo
Matching placebo for each dose level as tablet will be administered orally.
Interventions
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JNJ-64281802
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Placebo
Matching placebo for each dose level as tablet will be administered orally.
Eligibility Criteria
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Inclusion Criteria
* Must have a body mass index (BMI, weight in kilogram \[kg\] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m\^2) inclusive, and a body weight of greater than or equal to (\>=) 40.0 kg at screening
* A woman must have a negative highly sensitive urine pregnancy test at screening
* A male participant must agree not to donate sperm for the purpose of reproduction during the study and for \>= 90 days after receiving the last dose of study intervention
* Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
Exclusion Criteria
* Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
* Any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
* Reduced immune function to be: (a) Known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy)
* Received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 \[COVID-19\] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study
16 Years
65 Years
ALL
Yes
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Las Pinas Doctors Hospital
Las Piñas, , Philippines
Tropical Disease Foundation
Makati, , Philippines
Ponce School of Medicine, Caimed Ctr
Ponce, , Puerto Rico
The Hospital for Tropical Diseases
Bangkok, , Thailand
Songklanagarind hospital
Hat Yai, , Thailand
Srinagarind Hospital
Muang, , Thailand
Research Institute for Health Science, Chiang Mai University
Muang, , Thailand
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, , Brazil
HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso
Cuiabá, , Brazil
Hospital e Maternidade Sao Joao de Deus
Laranjeiras do Sul, , Brazil
Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, , Brazil
Fundacao Universidade Federal de Mato Grosso do Sul
Mato Grosso Do Sul, , Brazil
Policlínica Regional Dr Sérgio Arouca
Niterói, , Brazil
UPA Unidade de Pronto Atendimento Mário Monteiro
Niterói, , Brazil
Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO
Porto Velho, , Brazil
Centro Bangu - Centro Municipal de Saude Waldyr Franco
Rio de Janeiro, , Brazil
Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas
Rio de Janeiro, , Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
São José do Rio Preto, , Brazil
CAIMED Acacias
Acacías, , Colombia
CAIMED Aguazul
Aguazul, , Colombia
Centro de Reumatologia y Ortopedia
Barranquilla, , Colombia
Hospital Universidad del Norte
Barranquilla, , Colombia
Centre of Care and Diagnosis of the Infectious Diseases (CDI)
Bucaramanga, , Colombia
Centro de Investigaciones Clinicas S A S
Cali, , Colombia
Programa de Estudio y Control de Enfermedades Tropicales
Medellín, , Colombia
Centro de Atencion e Investigacion Medica S.A. - CAIMED
Yopal - Casanare, , Colombia
Klinik Kesihatan Kuang
Kuang, , Malaysia
Klinik Kesihatan Pandamaran
Port Klang, , Malaysia
Centro Medico Jojutla
Jojutla, , Mexico
Medical Care & Research SA de CV
Mérida, , Mexico
Unidad de Proyectos Clínicos de Oriente UPCO
Valladolid, , Mexico
FAICIC S. de R.L. de C.V.
Veracruz, , Mexico
Cevaxin 24 de diciembre
Cuidad de Panama, , Panama
Centro de Vacunacion Internacional CEVAXIN Av Mexico
Panama City, , Panama
Cevaxin La Chorrera
Panama City, , Panama
INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá
Panama City, , Panama
Asociacion Civil Selva Amazonica (ACSA)
Iquitos, , Peru
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, , Philippines
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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64281802DNG2004
Identifier Type: OTHER
Identifier Source: secondary_id
CR109157
Identifier Type: -
Identifier Source: org_study_id
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