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

• Status: Not yet recruiting
• Trial end date: 2025-05-22
• Target enrollment: 0
• Participant gender: All

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 last day of dosing among participants who have no evidence of current DENV infection at baseline.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Janssen Research & Development, LLC

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 33.0 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 5 years such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria

• Known or suspected congenital or acquired immunodeficiency; or receipt of immunomodulation therapy such as anticancer chemotherapy or radiation therapy

• Received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 6 months before the planned first dose of study intervention, or received an investigational biologic product within 3 months or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study