NCT04818801

Safety, Reactogenicity and Immunogenicity Study of ReCOV

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of ReCOV, a Vaccine for COVID-19, in Healthy Adult Subjects

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Jiangsu Rec-Biotechnology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 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 different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV. The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.

Detailed description

A total of 100 participants will receive the following vaccine regime: First, 20 young adult participants (18 to 55 years old) will receive 20μg of ReCOV vaccine on days 0 and 21. Then, 20 young adult participants (18 to 55 years old) will receive 40μg of ReCOV vaccine on days 0 and 21, and 20 old adult participants (56 to 80 years old) will receive 20μg of ReCOV vaccine on days 0 and 21. Finally, 20 old adult participants (56 to 80 years old) will receive 40μg of ReCOV vaccine on days 0 and 21. In the same time, 8 participants for each cohort, total 32 participants will receive 0.5ml of normal saline on days 0 and 21. Safety and immunogenicity data will be collected throughout the study, which concludes at 12 month after the second dose.

Conditions

• Covid19

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant two-component COVID-19 vaccine (CHO cell)	The spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies.
OTHER	Placebo	Normal saline (0.9% sodium chloride solution),

Timeline

• Start date: 2021-06-18
• Primary completion: 2022-05-05
• Completion: 2022-05-05
• First posted: 2021-03-26
• Last updated: 2022-09-27

Locations

2 sites across 1 country: New Zealand