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

NCT05201794 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: CR10915764281802DNG2004
• Study Type: interventional
• Target: 1,595
• Locations: 9 countries
• Sites: 38

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.

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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)

  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

  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)

  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

  From start of drug administration (DB prophylactic Day 1) up to Day 50

• Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters

  Day 28

Study Arms (3)

High-dose JNJ-64281802 regimen (HDR)

EXPERIMENTAL

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

Low-dose JNJ-64281802 regimen (LDR)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.

Drug: Placebo

Interventions

JNJ-64281802 DRUG

JNJ-64281802 tablets will be administered orally as per the defined regimens.

High-dose JNJ-64281802 regimen (HDR); Low-dose JNJ-64281802 regimen (LDR)

Placebo DRUG

Matching placebo for each dose level as tablet will be administered orally.

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (38)

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, 31270901, Brazil

Location

HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso

Cuiabá, 78055-085, Brazil

Location

Hospital e Maternidade Sao Joao de Deus

Laranjeiras do Sul, 49170-000, Brazil

Location

Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado

Manaus, 69040-000, Brazil

Location

Fundacao Universidade Federal de Mato Grosso do Sul

Mato Grosso Do Sul, 79040-010, Brazil

Location

Policlínica Regional Dr Sérgio Arouca

Niterói, 24230-323, Brazil

Location

UPA Unidade de Pronto Atendimento Mário Monteiro

Niterói, 24230-323, Brazil

Location

Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO

Porto Velho, 76812-329, Brazil

Location

Centro Bangu - Centro Municipal de Saude Waldyr Franco

Rio de Janeiro, 21040-360, Brazil

Location

Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas

Rio de Janeiro, 21040-900, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base

São José do Rio Preto, 15090-000, Brazil

Location

CAIMED Acacias

Acacías, Colombia

Location

CAIMED Aguazul

Aguazul, 5FH5+44, Colombia

Location

Centro de Reumatologia y Ortopedia

Barranquilla, 080020, Colombia

Location

Hospital Universidad del Norte

Barranquilla, 80020, Colombia

Location

Centre of Care and Diagnosis of the Infectious Diseases (CDI)

Bucaramanga, Colombia

Location

Centro de Investigaciones Clinicas S A S

Cali, 760001, Colombia

Location

Programa de Estudio y Control de Enfermedades Tropicales

Medellín, 00000, Colombia

Location

Centro de Atencion e Investigacion Medica S.A. - CAIMED

Yopal - Casanare, 8500001, Colombia

Location

Klinik Kesihatan Kuang

Kuang, 48050, Malaysia

Location

Klinik Kesihatan Pandamaran

Port Klang, 42000, Malaysia

Location

Centro Medico Jojutla

Jojutla, 62900, Mexico

Location

Medical Care & Research SA de CV

Mérida, 97070, Mexico

Location

Unidad de Proyectos Clínicos de Oriente UPCO

Valladolid, CP97780, Mexico

Location

FAICIC S. de R.L. de C.V.

Veracruz, C.P. 91900, Mexico

Location

Cevaxin 24 de diciembre

Cuidad de Panama, Panama

Location

Centro de Vacunacion Internacional CEVAXIN Av Mexico

Panama City, Panama

Location

Cevaxin La Chorrera

Panama City, Panama

Location

INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá

Panama City, Panama

Location

Asociacion Civil Selva Amazonica (ACSA)

Iquitos, 16001, Peru

Location

De La Salle Health Sciences Institute- DLSUMC

Dasmariñas, 4114, Philippines

Location

Las Pinas Doctors Hospital

Las Piñas, 1700, Philippines

Location

Tropical Disease Foundation

Makati, 1230, Philippines

Location

Ponce School of Medicine, Caimed Ctr

Ponce, 00716, Puerto Rico

Location

The Hospital for Tropical Diseases

Bangkok, 10400, Thailand

Location

Songklanagarind hospital

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital

Muang, 40002, Thailand

Location

Research Institute for Health Science, Chiang Mai University

Muang, 50200, Thailand

Location

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Results Point of Contact

• Title: Senior Medical Leader
• Organization: Janssen Research & Development, LLC

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: February 22, 2023
• Primary Completion: June 26, 2024
• Study Completion: June 26, 2024
• Last Updated: July 31, 2025
• Results First Posted: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

BR (11); MY (2); PE (1); CO (8); PA (4); ME (4); PR (1); PH (3); TH (4)