drugset / Trial / NCT04295070

Safety and Immunogenicity of a Live-attenuated Vaccine Against Respiratory Syncytial Virus in Elderly Volunteers

NCT04295070 ↗

Phase 1 Completed 36 enrolled Codagenix, Inc
RandomizedParallel-groupDouble-blindPrevention

Summary

This Phase I trial will enroll 36 healthy adult volunteers. The study will enroll a sentinel group of 6 younger adults aged 18 to 49 years followed by approximately 30 healthy older adults aged 50 to 75 years. All participants will receive two doses, 28 days apart. The vaccine will be administered as nose drops to both the low and high dose cohorts.

Timeline

Start
2020-07-10
Primary completion
2021-03-06
Completion
2021-05-26

Outcome

Met primary endpoint

release “Phase 1 study of CodaVax-RSV in adults 55-75 years old, which achieved its primary safety endpoint” codagenix.com ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject CodaVax-RSV Vaccine — Intranasal