Status:
TERMINATED
A Study of JNJ-64281802 for the Prevention of Dengue Infection
Lead Sponsor:
Janssen Research & Development, LLC
Conditions:
Dengue
Eligibility:
All Genders
16-65 years
Phase:
PHASE2
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2024
Estimated Enrollment :
1595 Patients enrolled
Trial Details
Trial ID
NCT05201794
Start Date
February 22 2023
End Date
June 26 2024
Last Update
July 31 2025
Active Locations (38)
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1
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, Brazil, 31270901
2
HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato Grosso
Cuiabá, Brazil, 78055-085
3
Hospital e Maternidade Sao Joao de Deus
Laranjeiras do Sul, Brazil, 49170-000
4
Fundacao De Medicina Tropical Doutor Heitor Vieira Dourado
Manaus, Brazil, 69040-000