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

Janssen (J&J Innovative Medicine)

Status and phase: Enrolling; Phase 2

Conditions: Dengue

Treatments: Drug: Placebo; Drug: JNJ-64281802

Study type: Interventional

Funder types: Industry

Identifiers

NCT05201794

64281802DNG2004 (Other Identifier)

CR109157

Details and patient eligibility

About

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.

Enrollment: 1,850 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,850 participants in 3 patient groups, including a placebo group

High-dose JNJ-64281802 regimen (HDR)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64281802

Low-dose JNJ-64281802 regimen (LDR)

Experimental group

Description:

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.

Treatment:

Drug: JNJ-64281802

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo