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

• Study Type: Interventional
• Enrollment (Actual): 1595
• Phase: Phase 2

Contacts and Locations

Study Locations

• Brazil
  • Belo Horizonte, Brazil, 31270901
    • Universidade Federal De Minas Gerais - Hospital das Clínicas
  • Cuiaba, Brazil, 78055-085
    • HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso
  • Laranjeiras do Sul, Brazil, 49170-000
    • Hospital e Maternidade Sao Joao de Deus
  • Manaus, Brazil, 69040-000
    • Fundação de Medicina Tropical Doutor Heitor Vieira Dourado
  • Mato Grosso Do Sul, Brazil, 79040-010
    • Fundacao Universidade Federal de Mato Grosso do Sul
  • Niterói, Brazil, 24230-323
    • Policlínica Regional Dr Sérgio Arouca
  • Niterói, Brazil, 24230-323
    • UPA Unidade de Pronto Atendimento Mário Monteiro
  • Porto Velho, Brazil, 76812-329
    • Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO
  • Rio de Janeiro, Brazil, 21040-360
    • Centro Bangu - Centro Municipal de Saude Waldyr Franco
  • Rio de Janeiro, Brazil, 21040-900
    • Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas
  • Sao Jose do Rio Preto, Brazil, 15090-000
    • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
• Colombia
  • Acacías, Colombia
    • CAIMED Acacias
  • Aguazul, Colombia, 5FH5+44
    • CAIMED Aguazul
  • Barranquilla, Colombia, 080020
    • Centro de Reumatologia y Ortopedia
  • Barranquilla, Colombia, 80020
    • Hospital Universidad del Norte
  • Bucaramanga, Colombia
    • Centre of Care and Diagnosis of the Infectious Diseases (CDI)
  • Cali, Colombia, 760001
    • Centro de Investigaciones Clinicas S A S
  • Medellin, Colombia, 00000
    • Programa de Estudio y Control de Enfermedades Tropicales
  • Yopal - Casanare, Colombia, 8500001
    • Centro de Atencion e Investigacion Medica S.A. - CAIMED
• Malaysia
  • Kuang, Malaysia, 48050
    • Klinik Kesihatan Kuang
  • Pelabuhan Klang, Malaysia, 42000
    • Klinik Kesihatan Pandamaran
• Mexico
  • Jojutla De Juárez, Mexico, 62900
    • Centro Medico Jojutla
  • Merida, Mexico, 97070
    • Medical Care & Research SA de CV
  • Valladolid, Mexico, CP97780
    • Unidad de Proyectos Clínicos de Oriente UPCO
  • Veracruz, Mexico, C.P. 91900
    • FAICIC S. de R.L. de C.V.
• Panama
  • Cuidad De Panama, Panama
    • CEVAXIN 24 de diciembre
  • 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
• Peru
  • Iquitos, Peru, 16001
    • Asociación Civil Selva Amazónica (ACSA)
• Philippines
  • Dasmarinas, Philippines, 4114
    • De La Salle Health Sciences Institute- DLSUMC
  • Las Pinas, Philippines, 1700
    • Las Piñas Doctors Hospital
  • Makati, Philippines, 1230
    • Tropical Disease Foundation
• Puerto Rico
  • Ponce, Puerto Rico, 00716
    • Ponce School of Medicine, Caimed Ctr
• Thailand
  • Bangkok, Thailand, 10400
    • The Hospital for Tropical Diseases
  • Hat Yai, Thailand, 90110
    • Songklanagarind Hospital
  • Muang, Thailand, 40002
    • Srinagarind Hospital
  • Muang, Thailand, 50200
    • 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 + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline	Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction [RT-PCR]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction [PCR] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to [>=] 11 relative units per milliliter [RU/mL]).	Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)

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 + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline)	Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for >=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL).	Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline	Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for >=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result >=11 RU/mL).	Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)	An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.	DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90
Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs	Vital signs: pulse and blood pressure (systolic blood pressure[SBP]/diastolic blood pressure[DBP]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury[mmHg]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (>)150-155, G3(severe):>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (<)85, G3(severe):<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):>95-100, G3(severe):>100; Pulse(beats per minutes[bpm]):Tachycardia: G1(mild):>100-115, G2(moderate):>115-130, G3(severe):>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):<50-45, G3(severe):<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.	From start of drug administration (DB prophylactic Day 1) up to Day 50
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters	ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: < 45, high: >=120; PR Interval (milliseconds [ms]): low: <110, high: >=220; QRS interval (ms): high: >=120; QTcB and QTcF (ms): Borderline prolonged QT: 450< QTc <=480, 480 <QTc <=500, QTc >500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.	Day 28
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters	Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.	From start of drug administration (DB prophylactic Day 1) up to Day 50
Number of Participants With Clinically Significant Abnormalities in Physical Examinations	Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion.	Day 50
Plasma Concentrations of JNJ-64281802	Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.	Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90

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 (Actual): June 26, 2024
• Study Completion (Actual): June 26, 2024

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): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vector Borne Diseases; Mosquito-Borne Diseases; Infections; RNA Virus Infections; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; 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