A Phase 1 Safety Study of Dengusiil in Healthy Adults

Phase 1 Completed 60 enrolled Serum Institute of India Pvt. Ltd. PPD Australia Pty Ltd · collab

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a Phase 1 study to assess safety and tolerability of a single subcutaneous dose of Dengusiil in healthy adults of 18 to 45 years of age. In this study, immune response to Dengusiil will also be assessed over a period of 6 months and vaccine viremia will also be assessed over a period of 12 days after administration of vaccine.

Timeline

Start: 2019-12-17
Primary completion: 2021-06-11
Completion: 2021-06-11

Publications

Results Gunale B, Farinola N, Yeolekar L, Shrivastava S, Girgis H, Poonawalla CS, Dhere RM, Arankalle V, Chandra Mishra A, Mehla R, Kulkarni PS. A Phase 1, double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a tetravalent live attenuated dengue vaccine in adults. Vaccine. 2023 Aug 31;41(38):5614-5621. doi: 10.1016/j.vaccine.2023.07.045. Epub 2023 Jul 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dengusiil	Unknown	0.5 ml	Subcutaneous

Indications

No indication recorded.