NCT05366296

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

Withdrawn Phase 1 Last updated 25 April 2023

What this trial tests

Phase 1 trial testing A Lyophilized COVID-19 mRNA Vaccine in COVID-19 Pandemic. Withdrawn.

Timeline

1 July 2022

Primary endpoint
1 September 2022

1 January 2023

Quick facts

Lead sponsor	Wuhan Recogen Biotechnology Co., Ltd.
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	prevention
Start date	1 July 2022
Primary completion	1 September 2022
Estimated completion	1 January 2023

Drugs / interventions tested

• A Lyophilized COVID-19 mRNA Vaccine — full drug profile →
• Placebo

Conditions studied

• COVID-19 Pandemic — all drugs for COVID-19 Pandemic →

Sponsor

Wuhan Recogen Biotechnology Co., Ltd. — full company profile →

Who can join

Adults 18 to 60, any sex, with COVID-19 Pandemic. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The occurrence of solicited local and systemic adverse events (AEs) within 7 days after the booster vaccination
  Time frame: Within 7days after each does
• The occurrence of unsolicited AEs within 28 days after the booster vaccination.
  Time frame: Time Frame: within 28 days after the booster vaccination
• The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) until 6 months after the booster vaccination
  Time frame: Until 6 months after the booster vaccination

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent Advances in Lipid Nanoparticles for Delivery of mRNA.
   Yang L, Gong L, Wang P, Zhao X, et al · · 2022 · cited 105× · PMID 36559175 · DOI 10.3390/pharmaceutics14122682
2. Recent progress in drying technologies for improving the stability and delivery efficiency of biopharmaceuticals.
   Emami F, Keihan Shokooh M, Mostafavi Yazdi SJ. · · 2023 · cited 31× · PMID 36568503 · DOI 10.1007/s40005-022-00610-x
3. The race for clinical trials on Omicron-based COVID-19 vaccine candidates: Updates from global databases.
   Viveiros-Rosa SG, Mendes CD, Farfán-Cano GG, El-Shazly M. · · 2022 · cited 27× · PMID 38449904 · DOI 10.52225/narra.v2i3.88
4. mRNA vaccines: A novel weapon to control infectious diseases.
   Tian Y, Deng Z, Yang P. · · 2022 · cited 14× · PMID 36267192 · DOI 10.3389/fmicb.2022.1008684
5. Race with virus evolution: The development and application of mRNA vaccines against SARS-CoV-2.
   Lee KM, Lin SJ, Wu CJ, Kuo RL. · · 2023 · cited 9× · PMID 36642222 · DOI 10.1016/j.bj.2023.01.002
6. Design, optimization, and evaluation of lyophilized lipid nanoparticles for mRNA-based pulmonary mucosal vaccination.
   Lu Y, Yang Y, Yi J, Hong X, et al · · 2025 · cited 7× · PMID 40475859 · DOI 10.1016/j.mtbio.2025.101813
7. Research progress of mRNA vaccines for infectious diseases.
   Zhang Z, Du J, Zhang D, Han R, et al · · 2025 · cited 5× · PMID 40847375 · DOI 10.1186/s40001-025-03060-x
8. Comparative analysis of the effectiveness difference of SARS-COV-2 mRNA vaccine in different populations in the real world: A review.
   Cai S, Chang C, Zhang X, Qiao W. · · 2023 · cited 4× · PMID 37653835 · DOI 10.1097/md.0000000000034805