A Study of JNJ-64281802 for the Prevention of Dengue Infection
- Registration Number
- NCT05201794
- Lead Sponsor
- Janssen Research & Development, LLC
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1256
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose JNJ-64281802 regimen (HDR) JNJ-64281802 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. Low-dose JNJ-64281802 regimen (LDR) JNJ-64281802 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. Placebo Placebo Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.
- Primary Outcome Measures
Name Time Method 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 Baseline up to Day 28 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.
- Secondary Outcome Measures
Name Time Method Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among All Participants Baseline up to Day 28 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.
Number of Participants with Abnormalities in Physical Examinations Up to 7 weeks 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.
Area Under the Concentration Curve of JNJ-64281802 During One Dosing Interval (AUCtau) Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose AUCtau is defined as area under the concentration curve of JNJ-64281802 during one dosing interval.
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 Baseline up to Day 28 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.
Number of Participants with Adverse Events (AEs) Up to 7 weeks 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.
Number of Participants with Serious Adverse Events (SAEs) Up to 7 weeks 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.
Number of Participants with Abnormalities in Vital Signs Up to 7 weeks Number of participants with abnormalities in vital signs (including temperature, pulse or heart rate, blood pressure \[systolic and diastolic\]) will be reported.
Number of Participants with Abnormalities in Clinical Laboratory Assessments Up to 7 weeks Number of participants with abnormalities in clinical laboratory assessments (serum chemistry, hematology and coagulation, and urinalysis) will be reported.
Observed JNJ-64281802 Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough) Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose Ctrough is defined as observed plasma concentration of JNJ-64281802 just prior to the beginning or at the end of a dosing interval.
Maximum Plasma Concentration (Cmax) of JNJ-64281802 Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose Cmax is defined as the maximum plasma concentration of JNJ-64281802.
Number of Participants with Abnormalities in Electrocardiograms (ECGs) Up to 7 weeks Number of participants with abnormalities in ECGs will be reported.
Trial Locations
- Locations (38)
Centro Bangu - Centro Municipal de Saude Waldyr Franco
🇧🇷Rio de Janeiro, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
🇧🇷Sao Jose do Rio Preto, Brazil
Universidade Federal De Minas Gerais - Hospital das ClÃnicas
🇧🇷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
PoliclÃnica 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
CAIMED Acacias
🇨🇴AcacÃas, 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, Colombia
Klinik Kesihatan Kuang
🇲🇾Kuang, Malaysia
Klinik Kesihatan Pandamaran
🇲🇾Pelabuhan Klang, Malaysia
Centro Medico Jojutla
🇲🇽Jojutla De Juárez, Mexico
Medical Care & Research SA de CV
🇲🇽Merida, Mexico
Unidad de Proyectos ClÃnicos 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, Panama
Cevaxin La Chorrera
🇵🇦Panama, Panama
INDICASAT Instituto de Investigaciones CientÃficas y Servicios de Alta TecnologÃa de Panamá
🇵🇦Panama, Panama
Asociacion Civil Selva Amazonica (ACSA)
🇵🇪Iquitos, Peru
De La Salle Health Sciences Institute- DLSUMC
🇵ðŸ‡Dasmarinas, Philippines
Las Pinas Doctors Hospital
🇵ðŸ‡Las Pinas, Philippines
Tropical Disease Foundation
🇵ðŸ‡Makati, Philippines
Ponce School of Medicine, Caimed Ctr
🇵🇷Ponce, Puerto Rico
The Hospital for Tropical Diseases
🇹ðŸ‡Bangkok, Thailand
Songklanagarind hospital
🇹ðŸ‡Hat Yai, Thailand
Srinagarind Hospital
🇹ðŸ‡Muang, Thailand
Research Institute for Health Science, Chiang Mai University
🇹ðŸ‡Muang, Thailand