drugset / Trial / NCT05769049

The Safety and Immunogenicity Study of the Recombinant Zoster Vaccine (CHO Cell)

NCT05769049

Phase 1 Completed 48 enrolled Jiangsu Rec-Biotechnology Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a randomized, observer-blinded, active-controlled Phase I study to evaluate the safety, reactogenicity, and immunogenicity of REC610, when administered as 2 intramuscular (IM) injections in healthy adults aged 40 years and older, who do not have known HZ and history of varicella or HZ vaccination. The recombinant HZ vaccine, Shingrix® (GlaxoSmithKline), will be used as the active control.

Timeline

Start
2023-02-09
Primary completion
2023-12-06
Completion
2023-12-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Recombinant Zoster Vaccine (CHO Cell) Vaccine 50 ug Intramuscular
Comparator VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E Vaccine 50 ug Intramuscular

Indications