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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dengue
• Intervention / Treatment: Drug: JNJ-64281802; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 1850
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 844-434-4210; Email: Participate-In-This-Study@its.jnj.com

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 31270901
    • Recruiting
    • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Cuiaba, Brazil, 78055-085
    • Recruiting
    • HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso
  • Laranjeiras do Sul, Brazil, 49170-000
    • Recruiting
    • Hospital e Maternidade Sao Joao de Deus
  • Manaus, Brazil, 69040-000
    • Recruiting
    • Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
  • Mato Grosso Do Sul, Brazil, 79040-010
    • Recruiting
    • Fundacao Universidade Federal de Mato Grosso do Sul
  • Niterói, Brazil, 24230-323
    • Recruiting
    • Policlínica Regional Dr Sérgio Arouca
  • Niterói, Brazil, 24230-323
    • Recruiting
    • UPA Unidade de Pronto Atendimento Mário Monteiro
  • Porto Velho, Brazil, 76812-329
    • Recruiting
    • Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO
  • Rio de Janeiro, Brazil, 21040-900
    • Recruiting
    • Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Recruiting
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
• Colombia
  • Acacías, Colombia
    • Recruiting
    • CAIMED Acacias
  • Aguazul, Colombia, 5FH5+44
    • Recruiting
    • CAIMED Aguazul
  • Barranquilla, Colombia, 080020
    • Recruiting
    • Centro de Reumatologia y Ortopedia
  • Barranquilla, Colombia, 80020
    • Recruiting
    • Hospital Universidad del Norte
  • Bucaramanga, Colombia
    • Suspended
    • Centre of Care and Diagnosis of the Infectious Diseases (CDI)
  • Cali, Colombia, 760001
    • Recruiting
    • Centro de Investigaciones Clinicas S A S
  • Medellin, Colombia, 00000
    • Recruiting
    • Programa de Estudio y Control de Enfermedades Tropicales
  • Yopal - Casanare, Colombia, 8500001
    • Recruiting
    • Centro de Atencion e Investigacion Medica S.A. - CAIMED
• Malaysia
  • Kuang, Malaysia, 48050
    • Recruiting
    • Klinik Kesihatan Kuang
  • Pelabuhan Klang, Malaysia, 42000
    • Recruiting
    • Klinik Kesihatan Pandamaran
• Mexico
  • Jojutla De Juárez, Mexico, 62900
    • Recruiting
    • Centro Medico Jojutla
  • Merida, Mexico, 97070
    • Recruiting
    • Medical Care & Research SA de CV
  • Valladolid, Mexico, CP97780
    • Recruiting
    • Unidad de Proyectos Clínicos de Oriente UPCO
  • Veracruz, Mexico, C.P. 91900
    • Recruiting
    • FAICIC S. de R.L. de C.V.
• Panama
  • Cuidad De Panama, Panama
    • Recruiting
    • Cevaxin 24 de diciembre
  • Panama, Panama
    • Recruiting
    • Centro de Vacunacion Internacional CEVAXIN Av Mexico
  • Panama, Panama
    • Recruiting
    • Cevaxin La Chorrera
  • Panama, Panama
    • Recruiting
    • INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá
• Peru
  • Iquitos, Peru, 16001
    • Suspended
    • Asociacion Civil Selva Amazonica (ACSA)
• Philippines
  • Dasmarinas, Philippines, 4114
    • Recruiting
    • De La Salle Health Sciences Institute- DLSUMC
  • Las Pinas, Philippines, 1700
    • Recruiting
    • Las Pinas Doctors Hospital
  • Makati, Philippines, 1230
    • Recruiting
    • Tropical Disease Foundation
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Recruiting
    • Ponce School of Medicine, Caimed Ctr
• Thailand
  • Bangkok, Thailand, 10400
    • Recruiting
    • The Hospital for Tropical Diseases
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Songklanagarind Hospital
  • Muang, Thailand, 40002
    • Recruiting
    • Srinagarind Hospital
  • Muang, Thailand, 50200
    • Recruiting
    • Research Institute for Health Science, Chiang Mai University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Experimental: 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.	Drug: JNJ-64281802; JNJ-64281802 tablets will be administered orally as per the defined regimens.
Placebo Comparator: Placebo; Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.	Drug: Placebo; Matching placebo for each dose level as tablet will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Number of Participants with Abnormalities in Electrocardiograms (ECGs)	Number of participants with abnormalities in ECGs will be reported.	Up to 7 weeks
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC
• Investigators: Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Estimated): May 22, 2025
• Study Completion (Estimated): May 22, 2025

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Mosquito-Borne Diseases; Dengue
• Other Study ID Numbers: CR109157; 64281802DNG2004 (Other Identifier: Janssen Research & Development, LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency.

As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No