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Safety, Reactogenicity and Immunogenicity Study of ReCOV

NCT04818801 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-09-27

No results posted yet for this study

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.

Conditions

  • Covid19

Interventions

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),

Sponsors & Collaborators

  • Iqvia Pty Ltd

    collaborator INDUSTRY

  • Jiangsu Rec-Biotechnology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-06-18
Primary Completion
2022-05-05
Completion
2022-05-05

Countries

  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04818801 on ClinicalTrials.gov