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

Dengue Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for the Prevention of Dengue Infection

Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

• Verified date: June 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
• 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

Related Conditions & MeSH terms

• Dengue

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