Wuhan Recogen Biotechnology Co., Ltd.
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.
COVID-19 Pandemic
A Lyophilized COVID-19 mRNA Vaccine
Placebo
Phase 1
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)}}
Study Type : | Interventional |
Estimated Enrollment : | 0 participants |
Masking : | Quadruple |
Primary Purpose : | Prevention |
Official Title : | 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 |
Actual Study Start Date : | July 2022 |
Estimated Primary Completion Date : | September 2022 |
Estimated Study Completion Date : | January 2023 |
Arm | Intervention/treatment |
---|---|
Active Comparator: : A Lyophilized COVID-19 mRNA Vaccine(RH109) Participants received A Lyophilized COVID-19 mRNA Vaccine 0.5ml reconstituted by sterile water, 1 shots at Day0, intramuscular injection |
Biological: A Lyophilized COVID-19 mRNA Vaccine |
Placebo Comparator: Placebo control Participants received placebo of 0.5ml normal saline (0.9% sodium chloride solution), 1 shots at Day0, intramuscular injection |
Biological: Placebo |
Ages Eligible for Study: | 18 Years to 60 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Accepts Healthy Volunteers |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.