Clinical Trials Logo
  1. Home
  2. Other
  3. NCT05366296

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

COVID-19 Pandemic Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05366296
Study type Interventional
Source Wuhan Recogen Biotechnology Co., Ltd.
Contact
Status Withdrawn
Phase Phase 1
Start date July 2022
Completion date January 2023
View Details
See also
  Status Clinical Trial Phase
Completed NCT05197634 - The Impact of Covid-19 Pandemic On The Children With Autism Spectrum Disorder
Recruiting NCT05918939 - UNAIR Inactivated COVID-19 Vaccine as Heterologue Booster (Immunobridging Study) Early Phase 1
Completed NCT05383560 - Safety and Immunogenicity of Omicron Variant-Matched Vaccine Booster in Adults Phase 2
Active, not recruiting NCT05125874 - Clinical Study for Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Immunization N/A
Completed NCT05517148 - Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Stress Reduction N/A
Completed NCT05552989 - Towards Better Preparedness for Future Catastrophes - Local Lessons-learned From COVID-19
Completed NCT05543551 - Effects of Diagrammatic Breathing With and Without Resistance in Post Covid Patients on ADLs N/A
Active, not recruiting NCT06272253 - UNAIR Inactivated COVID-19 Vaccine INAVAC as Heterologue Booster (Immunobridging Study) in Adolescent Subjects Early Phase 1
Active, not recruiting NCT05585567 - A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5 Early Phase 1
Not yet recruiting NCT05381883 - Mental Health of Professionals of the Silver Economy of New Aquitaine : Online Survey of Accommodation Establishments for Old People and Home Assistance Establishments N/A
Active, not recruiting NCT05582746 - COVID-19 Testing and Vaccine Literacy for Women With Criminal Legal System Involvement N/A
Recruiting NCT05062681 - RCT on the Efficacy of Dexamethasone Versus Methyl Prednisolone in Covid-19 Infected Patients With High Oxygen Flow Phase 4
Completed NCT04697030 - Burnout Among Adolescent Population During Covid-19 Lockdown in Pakistan
Active, not recruiting NCT05419167 - STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic Phase 1
Completed NCT06435390 - Coronavirus Disease 2019 (COVID-19) Pandemic on the Oral Hygiene Status of Children
Terminated NCT05553964 - SARS-CoV-2 OTC At Home Test N/A
Completed NCT05596032 - Prospective Study to Validate the Diagnostic Performance of IVD CAPSULE COVID-19-NP Test for the Detection of SARS-CoV-2
Completed NCT05583812 - A Study of FB2001 for Inhalation in Healthy Chinese Adults Phase 1
Completed NCT05844410 - Evaluation of Corticosteroids Use and Clinical Outcomes in Hospitalized COVID-19 Patients: A Retrospective Study
Completed NCT05123573 - Self-Perceived in Medical Students Undergoing Distance Learning