Clinical trial NCT05201794: A Study of JNJ-64281802 for the Prevention of Dengue Infection
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Dengue
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2022-01-21
Enrollment: 1256
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Baseline up to Day 28
Secondary outcomes:
measure: Number of Participants with Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing Among All Participants
timeFrame: Baseline up to Day 28
measure: 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
timeFrame: Baseline up to Day 28
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 7 weeks
measure: Number of Participants with Serious Adverse Events (SAEs)
timeFrame: Up to 7 weeks
measure: Number of Participants with Abnormalities in Physical Examinations
timeFrame: Up to 7 weeks
measure: Number of Participants with Abnormalities in Vital Signs
timeFrame: Up to 7 weeks
measure: Number of Participants with Abnormalities in Electrocardiograms (ECGs)
timeFrame: Up to 7 weeks
measure: Number of Participants with Abnormalities in Clinical Laboratory Assessments
timeFrame: Up to 7 weeks
measure: Area Under the Concentration Curve of JNJ-64281802 During One Dosing Interval (AUCtau)
timeFrame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
measure: Observed JNJ-64281802 Concentration Just Prior to the Beginning or at the End of a Dosing Interval (Ctrough)
timeFrame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
measure: Maximum Plasma Concentration (Cmax) of JNJ-64281802
timeFrame: Day 1 (Pre-dose), Days 3, 5, 9, 13, 21, 28, 40, 50 and 90 Post-dose
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Cuiaba
country: Brazil
facility: HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso
city: Laranjeiras do Sul
country: Brazil
facility: Hospital e Maternidade Sao Joao de Deus
city: Manaus
country: Brazil
facility: Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
city: Mato Grosso Do Sul
country: Brazil
facility: Fundacao Universidade Federal de Mato Grosso do Sul
city: Niterói
country: Brazil
facility: Policlínica Regional Dr Sérgio Arouca
city: Niterói
country: Brazil
facility: UPA Unidade de Pronto Atendimento Mário Monteiro
city: Porto Velho
country: Brazil
facility: Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATRO
city: Rio de Janeiro
country: Brazil
facility: Centro Bangu - Centro Municipal de Saude Waldyr Franco
city: Rio de Janeiro
country: Brazil
facility: Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro Chagas
city: Sao Jose do Rio Preto
country: Brazil
facility: Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de Base
city: Acacías
country: Colombia
facility: CAIMED Acacias
city: Aguazul
country: Colombia
facility: CAIMED Aguazul
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y Ortopedia
city: Barranquilla
country: Colombia
facility: Hospital Universidad del Norte
city: Bucaramanga
country: Colombia
facility: Centre of Care and Diagnosis of the Infectious Diseases (CDI)
city: Cali
country: Colombia
facility: Centro de Investigaciones Clinicas S A S
city: Medellin
country: Colombia
facility: Programa de Estudio y Control de Enfermedades Tropicales
city: Yopal - Casanare
country: Colombia
facility: Centro de Atencion e Investigacion Medica S.A. - CAIMED
city: Kuang
country: Malaysia
facility: Klinik Kesihatan Kuang
city: Pelabuhan Klang
country: Malaysia
facility: Klinik Kesihatan Pandamaran
city: Jojutla De Juárez
country: Mexico
facility: Centro Medico Jojutla
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Valladolid
country: Mexico
facility: Unidad de Proyectos Clínicos de Oriente UPCO
city: Veracruz
country: Mexico
facility: FAICIC S. de R.L. de C.V.
city: Cuidad De Panama
country: Panama
facility: Cevaxin 24 de diciembre
city: Panama
country: Panama
facility: Centro de Vacunacion Internacional CEVAXIN Av Mexico
city: Panama
country: Panama
facility: Cevaxin La Chorrera
city: Panama
country: Panama
facility: INDICASAT Instituto de Investigaciones Científicas y Servicios de Alta Tecnología de Panamá
city: Iquitos
country: Peru
facility: Asociacion Civil Selva Amazonica (ACSA)
city: Dasmarinas
country: Philippines
facility: De La Salle Health Sciences Institute- DLSUMC
city: Las Pinas
country: Philippines
facility: Las Pinas Doctors Hospital
city: Makati
country: Philippines
facility: Tropical Disease Foundation
city: Ponce
country: Puerto Rico
facility: Ponce School of Medicine, Caimed Ctr
city: Bangkok
country: Thailand
facility: The Hospital for Tropical Diseases
city: Hat Yai
country: Thailand
facility: Songklanagarind hospital
city: Muang
country: Thailand
facility: Srinagarind Hospital
city: Muang
country: Thailand
facility: Research Institute for Health Science, Chiang Mai University
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: