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

NCT05201794 ↗

Phase 2 Terminated 1595 enrolled Janssen Research & Development, LLC

RandomizedParallel-groupDouble-blindPrevention

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.

Timeline

Start: 2023-02-22
Primary completion: 2024-06-26
Completion: 2024-06-26

Outcome

Missed primary endpoint

Stopped (Business): “The study was stopped due to portfolio reprioritization. This decision is not based on any safety concerns.”

registry analysis (superiority test); JNJ-64281802: High Dose Regimen vs Placebo; p =0.1409; Odds Ratio (OR) 67.3 NCT05201794 ↗

registry analysis (superiority test); JNJ-64281802: Low Dose Regimen vs Placebo; p =0.1418; Odds Ratio (OR) 67.2 NCT05201794 ↗

Publications

Bouzidi HS, De Lamballerie X, Touret F. Therapeutic approaches against dengue virus: current status of vaccines, antivirals, and monoclonal antibodies. Emerg Microbes Infect. 2026 Dec;15(1):2686471. doi: 10.1080/22221751.2026.2686471. Epub 2026 Jun 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	mosnodenvir	Small molecule	50 mg	Oral
Subject	mosnodenvir	Small molecule	150 mg	Oral