NCT05366296

Safety, Reactogenicity, and Immunogenicity Study of a Lyophilized COVID-19 mRNA Vaccine

A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Wuhan Recogen Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. In this phase I first-in-human clinical trial, healthy volunteers in two dose cohorts will be vaccinated Lyophilized COVID-19 mRNA Vaccine (RH109) The aim of the study is to assess the safety, reactogenicity and Immunogenicity of the candidate vaccine and to characterize its immunogenicity.

Detailed description

Participants will be enrolled into 2 ascending dose (RH109 low-dose 25 μg, high-dose 50 μg) cohorts randomly. Approximately 24 eligible participants, 12 for each cohort, will be randomized with a 3:1 ratio (RH109 : Placebo). The study will progress in a sequential manner, with the low-dose cohort being enrolled and dosed first. Dose escalation from low-dose to high-dose cohort is contingent on a review of safety data of the low-dose cohort through to 7 days following the vaccination by a Safety Monitoring Committee (SMC)

Conditions

• COVID-19 Pandemic

Interventions

Type	Name	Description
BIOLOGICAL	A Lyophilized COVID-19 mRNA Vaccine	Active substance: NTD-RBD derived from S protein of Omicron variant Excipient: ALC-0315 (4- hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2- hexyldecanoate), ALC-0159 (2-\[(polyethylene glycol)-2000\]-N, N-ditetradecylacetamide), DSPC \[1,2- distearoyl-sn-glycero-3-phosphocholine\], Cholesterol, Trometamol and Sucrose
BIOLOGICAL	Placebo	Normal saline (0.9% sodium chloride solution

Timeline

• Start date: 2022-07-01
• Primary completion: 2022-09-01
• Completion: 2023-01-01
• First posted: 2022-05-09
• Last updated: 2023-04-27