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Booster Immunization Study of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01)

NCT05050474 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-04-25

No results posted yet for this study

Summary

This study is a continuation study of the original V-01-I phase trial, using a single-center, single-arm, open design to evaluate the immunogenicity and safety of the third dose booster immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in healthy participants immunized with two doses schedule of V-01.

The primary objective is to evaluate the Immunogenicity of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

The secondary objective is to evaluate the safety of the third dose booster immunization of V-01 in healthy participants immunized with two doses schedule of V-01.

Conditions

  • COVID19

Interventions

BIOLOGICAL

Recombinant SARS-CoV-2 Fusion Protein Vaccine

The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.

Sponsors & Collaborators

  • Guangdong Center for Disease Prevention and Control

    collaborator OTHER_GOV

  • Simoon Record Pharma Information Consulting Co., Ltd.

    collaborator INDUSTRY

  • Livzon Pharmaceutical Group Inc.

    lead INDUSTRY

Principal Investigators

  • Zhang Jikai · Guangdong Center for Disease Prevention and Control

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-07
Primary Completion
2022-02-18
Completion
2022-02-18

Countries

  • China

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 NCT05050474 on ClinicalTrials.gov