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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05201794
Other study ID # CR109157
Secondary ID 64281802DNG2004
Status Recruiting
Phase Phase 2
First received
Last updated
Start date February 22, 2023
Est. completion date May 22, 2025

Study information

Verified date February 2024
Source Janssen Research & Development, LLC
Contact Study Contact
Phone 844-434-4210
Email Participate-In-This-Study@its.jnj.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1850
Est. completion date May 22, 2025
Est. primary completion date May 22, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 65 Years
Eligibility Inclusion Criteria: - Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only 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 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: - 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 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Brazil Universidade Federal De Minas Gerais - Hospital das Clínicas Belo Horizonte
Brazil HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso Cuiaba
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 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 Sao Jose do Rio Preto
Colombia 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 Medellin
Colombia Centro de Atencion e Investigacion Medica S.A. - CAIMED Yopal - Casanare
Malaysia Klinik Kesihatan Kuang Kuang
Malaysia Klinik Kesihatan Pandamaran Pelabuhan Klang
Mexico Centro Medico Jojutla Jojutla De Juárez
Mexico Medical Care & Research SA de CV Merida
Mexico Unidad de Proyectos Clínicos de Oriente UPCO Valladolid
Mexico FAICIC S. de R.L. de C.V. Veracruz
Panama Cevaxin 24 de diciembre Cuidad De Panama
Panama Centro de Vacunacion Internacional CEVAXIN Av Mexico Panama
Panama Cevaxin La Chorrera Panama
Panama INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá Panama
Peru Asociacion Civil Selva Amazonica (ACSA) Iquitos
Philippines De La Salle Health Sciences Institute- DLSUMC Dasmarinas
Philippines Las Pinas Doctors Hospital Las Pinas
Philippines Tropical Disease Foundation Makati
Puerto Rico Ponce School of Medicine, Caimed Ctr Ponce
Thailand The Hospital for Tropical Diseases Bangkok
Thailand Songklanagarind hospital Hat Yai
Thailand Research Institute for Health Science, Chiang Mai University Muang
Thailand Srinagarind Hospital Muang

Sponsors (1)

Lead Sponsor Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Brazil,  Colombia,  Malaysia,  Mexico,  Panama,  Peru,  Philippines,  Puerto Rico,  Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing Among Participants Who Have No Evidence of Current DENV Infection at Baseline Number of participants with laboratory-confirmed DENV infection between baseline and the last day of dosing among participants who have no evidence of current DENV infection at baseline will be reported. Presence of a laboratory-confirmed DENV infection is defined as a positive DENV ribonucleic acid (RNA) or DENV nonstructural (NS)1 protein test result. Baseline up to Day 28
Secondary Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among All Participants Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and the last day of dosing among all participants will be reported. Laboratory-confirmed symptomatic DENV infection is defined as having at least 2 solicited systemic adverse events (AEs), of which at least one is a most common dengue symptom (that is, fever, headache/retro-orbital pain, myalgia, arthralgia, rash), lasting for greater than or equal to (>=) 1 day and occurring within a plus/minus (+/-) 2 days time window around the positive polymerase chain reaction (PCR) or NS1 test, between baseline and the last day of dosing. Baseline up to Day 28
Secondary Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among Participants With No Evidence of Current DENV Infection at Baseline Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and the last day of dosing among participants who have no evidence of current DENV infection at baseline will be reported. Baseline up to Day 28
Secondary Number of Participants with Adverse Events (AEs) An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. Up to 7 weeks
Secondary Number of Participants with Serious Adverse Events (SAEs) SAE is any untoward medical occurrence that at any dose results in any of the following outcomes: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect; suspected transmission of any infectious agent via a medicinal product or medically important. Up to 7 weeks
Secondary Number of Participants with Abnormalities in Physical Examinations Number of participants with abnormalities in physical examinations (including examination of head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological body systems) will be reported. Up to 7 weeks
Secondary Number of Participants with Abnormalities in Vital Signs Number of participants with abnormalities in vital signs (including temperature, pulse or heart rate, blood pressure [systolic and diastolic]) will be reported. Up to 7 weeks
Secondary Number of Participants with Abnormalities in Electrocardiograms (ECGs) Number of participants with abnormalities in ECGs will be reported. Up to 7 weeks
Secondary Number of Participants with Abnormalities in Clinical Laboratory Assessments Number of participants with abnormalities in clinical laboratory assessments (serum chemistry, hematology and coagulation, and urinalysis) will be reported. Up to 7 weeks
Secondary Area Under the Concentration Curve of JNJ-64281802 During One Dosing Interval (AUCtau) AUCtau is defined as area under the concentration curve of JNJ-64281802 during one dosing interval. Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
Secondary Observed JNJ-64281802 Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning or at the end of a dosing interval. Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
Secondary Maximum Plasma Concentration (Cmax) of JNJ-64281802 Cmax is defined as the maximum plasma concentration of JNJ-64281802. Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
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