A Study of JNJ-64281802 for the Prevention of Dengue Infection

Last updated: January 31, 2025
Sponsor: Janssen Research & Development, LLC
Overall Status: Terminated

Phase

2

Condition

N/A

Treatment

Placebo

JNJ-64281802

Clinical Study ID

NCT05201794
CR109157
64281802DNG2004
  • Ages 16-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Healthy on the basis of physical examination, medical history, and vital signsperformed at screening. If there are abnormalities, the participant may be includedonly if the investigator judges the abnormalities to be not clinically relevant.This determination must be recorded in the participant's source documents

  • Must have a body mass index (BMI, weight in kilogram [kg] divided by the square ofheight 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 reproductionduring the study and for >= 90 days after receiving the last dose of studyintervention

  • Must sign an informed consent form (ICF) (or their legally acceptable representativemust sign) indicating that the participant understands the purpose of, andprocedures required for, the study and is willing to participate in the study

Exclusion

Exclusion Criteria:

  • Having any dengue virus (DENV)-associated clinical signs and symptoms

  • Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients

  • Any clinically relevant skin disease (as assessed by the investigator) in the past 3months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, foodallergy, and urticaria

  • Reduced immune function to be: (a) Known or suspected congenital or acquiredimmunodeficiency; or (b) receipt of immunomodulation therapy within the last 6months (such as anticancer chemotherapy or radiation therapy)

  • Received an investigational intervention (including investigational vaccines otherthan a corona virus disease 2019 [COVID-19] vaccine) or used an invasiveinvestigational medical device within 3 months before the planned first dose ofstudy intervention or received an investigational biologic product within 3 monthsprior to enrollment or 5 half-lives, whichever is longer, before the planned firstdose of study intervention, or is currently enrolled in an investigational study

Study Design

Total Participants: 1256
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
February 22, 2023
Estimated Completion Date:
June 26, 2024

Connect with a study center

  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 31270901
    Brazil

    Site Not Available

  • HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso

    Cuiaba, 78055-085
    Brazil

    Site Not Available

  • HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso

    Cuiabá, 78055-085
    Brazil

    Site Not Available

  • Hospital e Maternidade Sao Joao de Deus

    Laranjeiras do Sul, 49170-000
    Brazil

    Site Not Available

  • Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado

    Manaus, 69040-000
    Brazil

    Site Not Available

  • Fundacao Universidade Federal de Mato Grosso do Sul

    Mato Grosso Do Sul, 79040-010
    Brazil

    Site Not Available

  • Fundação Universidade Federal de Mato Grosso do Sul

    Mato Grosso Do Sul, 79040-010
    Brazil

    Active - Recruiting

  • Policlínica Regional Dr Sérgio Arouca

    Niterói, 24230-323
    Brazil

    Site Not Available

  • UPA Unidade de Pronto Atendimento Mário Monteiro

    Niterói, 24230-323
    Brazil

    Site Not Available

  • Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO

    Porto Velho, 76812-329
    Brazil

    Site Not Available

  • Instituto Nacional de Infectologia Evandro Chagas (INI) - FIOCRUZ

    Rio Janeiro, 21040-900
    Brazil

    Site Not Available

  • Centro Bangu - Centro Municipal de Saude Waldyr Franco

    Rio de Janeiro, 21040-360
    Brazil

    Site Not Available

  • Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas

    Rio de Janeiro, 21040-900
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    Sao Jose do Rio Preto, 15090-000
    Brazil

    Active - Recruiting

  • UFS - Universidade Federal de Sergipe

    Sergipe, 49060 100
    Brazil

    Site Not Available

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto - Hospital de Base

    São José do Rio Preto, 15090-000
    Brazil

    Site Not Available

  • CAIMED Acacias

    Acacías,
    Colombia

    Site Not Available

  • CAIMED Aguazul

    Aguazul, 5FH5+44
    Colombia

    Site Not Available

  • Centro de Reumatologia y Ortopedia

    Barranquilla, 080020
    Colombia

    Site Not Available

  • Hospital Universidad del Norte

    Barranquilla, 80020
    Colombia

    Site Not Available

  • Centre of Care and Diagnosis of the Infectious Diseases (CDI)

    Bucaramanga,
    Colombia

    Site Not Available

  • Centro de Investigaciones Clinicas S A S

    Cali, 760001
    Colombia

    Site Not Available

  • Centro de Investigaciones Clinicas S.A.S.

    Cali, 760001
    Colombia

    Active - Recruiting

  • Fundacion Oftalmologica de Santander - FOSCAL

    Floridablanca, 681002
    Colombia

    Site Not Available

  • Programa de Estudio y Control de Enfermedades Tropicales

    Medellin, 00000
    Colombia

    Site Not Available

  • Centro de Investigaciones Clinicas S.A.S.

    Santiago de Cali, 760043
    Colombia

    Site Not Available

  • Hospital Universidad del Norte

    Soledad, Atlantico,
    Colombia

    Site Not Available

  • Centro de Atencion e Investigacion Medica S.A. - CAIMED

    Yopal - Casanare, 8500001
    Colombia

    Site Not Available

  • Klinik Kesihatan Kajang

    Kajang, 62250
    Malaysia

    Site Not Available

  • University Malaya Medical Centre

    Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Klinik Kesihatan Kuang

    Kuang, 48050
    Malaysia

    Site Not Available

  • Klinik Kesihatan Pandamaran

    Pelabuhan Klang, 42000
    Malaysia

    Site Not Available

  • Hospital Taiping

    Taiping, 34000
    Malaysia

    Site Not Available

  • Antiguo Hospital Civil de Guadalajara Fray Antonio Alcalde

    Guadalajara, 44280
    Mexico

    Site Not Available

  • Centro Medico Jojutla

    Jojutla De Juárez, 62900
    Mexico

    Site Not Available

  • Medical Care & Research SA de CV

    Merida, 97070
    Mexico

    Site Not Available

  • Unidad de Proyectos Clínicos de Oriente UPCO

    Valladolid, CP97780
    Mexico

    Site Not Available

  • FAICIC S. de R.L. de C.V.

    Veracruz, C.P. 91900
    Mexico

    Site Not Available

  • Cevaxin 24 de diciembre

    Cuidad De Panama,
    Panama

    Site Not Available

  • Centro de Vacunacion Internacional CEVAXIN Av Mexico

    Panama,
    Panama

    Site Not Available

  • Cevaxin La Chorrera

    Panama,
    Panama

    Site Not Available

  • INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá

    Panama,
    Panama

    Site Not Available

  • Asociacion Civil Selva Amazonica (ACSA)

    Iquitos, 16001
    Peru

    Site Not Available

  • Philippines AFRIMS Virology Research Unit

    Cebu City, 6000
    Philippines

    Site Not Available

  • De La Salle Health Sciences Institute- DLSUMC

    Dasmarinas, 4114
    Philippines

    Site Not Available

  • Las Pinas Doctors Hospital

    Las Pinas, 1700
    Philippines

    Site Not Available

  • Tropical Disease Foundation

    Makati, 1230
    Philippines

    Site Not Available

  • Clinical Research Puerto Rico

    Guayama, 00784
    Puerto Rico

    Site Not Available

  • Ponce School of Medicine, Caimed Ctr

    Ponce, 00716
    Puerto Rico

    Site Not Available

  • Clinical Research Puerto Rico

    San Juan, 00909
    Puerto Rico

    Site Not Available

  • The Hospital for Tropical Diseases

    Bangkok, 10400
    Thailand

    Site Not Available

  • Chiang Mai University

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Songklanagarind hospital

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Research Institute for Health Science, Chiang Mai University

    Muang, 50200
    Thailand

    Site Not Available

  • Srinagarind Hospital

    Muang, 40002
    Thailand

    Site Not Available

  • Royal Thai Army, Afrims

    Ratchathewi, 10400
    Thailand

    Site Not Available

  • National Institute of Hygiene and Epidemiology

    Ha Noi, 100000
    Vietnam

    Site Not Available

  • HCMC Hospital for Tropical Disease

    Ho Chi Minh City, 70000
    Vietnam

    Site Not Available

  • Health Center of Ninh Hoa Town

    Khanh Hoa, 57000
    Vietnam

    Site Not Available

  • Pasteur Institute Nha Trang

    Nha Trang, 650000
    Vietnam

    Site Not Available

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