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

NCT05050474 | Completed Phase 1 DMC

• 1 other identifier: V-01-I-Booster
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Immunogenicity Endpoints

  1. The seroconvension, GMT, and GMI of SARS-CoV-2 neutralizing antibodies (live virus, pseudovirus neutralizing test method) 2. The seroconvension, GMT, and GMI of SARS-CoV-2 RBD antibodies (Enzyme-linked Immuno Sorbent Assay，ELISA)

  14 days after booster immunization

Secondary Outcomes (1)

• Safety Endpoints

  Day 0-7 after booster immunization, 6 months after booster immunization

Study Arms (1)

V-01 COVID-19 Vaccine

EXPERIMENTAL

One dose administrated by intramuscular injection

Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine

Interventions

Recombinant SARS-CoV-2 Fusion Protein Vaccine BIOLOGICAL

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

Also known as: V-01

V-01 COVID-19 Vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntarily participate in the study and sign the informed consent form
• The participants who were enrolled in the 10 μg test group in the previous study titled "A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Participants", and went through the full course immunization without meeting the exclusive criteria.
• No history of contact with confirmed, asymptomatic or suspected COVID-19 cases.
• Males of reproductive potential and females of childbearing potential voluntarily agree to take effective and acceptable contraceptive methods from the signing of informed consent form to 6 months after vaccination; females of childbearing age refer to premenopausal women and women within 2 years after menopause.

You may not qualify if:

• Innoculated with COVID-19 vaccines other than V-01;
• History of high fever (axillary temperature ≥ 39℃) and last for more than 3 days, or serious allergic reactions during the last immunization with V-01;
• History of obvious allergic reactions or allergic reactions that needed to be medical intervention during the last immunization with V-01;
• After two doses of V-01 inoculation, a newly diagnosed severe chronic disease or the original chronic disease is poorly controlled by drugs (applicable to ≥60 years old): history of chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis) , Hypertension which can not be controlled by drugs (systolic blood pressure ≥140mmHg and/or diastolic blood pressure ≥90mmHg), history of severe cardiovascular disease (including heart failure, coronary artery disease, cardiomyopathy), history of chronic kidney disease, history of cancer, diabetes (blood sugar) Unsatisfactory control or serious complications related to diabetes);
• Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (\<14 days);
• Having received immunoglobulin and/or any blood products 3 months prior to the investigational vaccine dose;
• Other scenarios that may be medically, psychologically or socially contradicted with the trial protocol at the investigator's discretion or preclude informed consents of the participants.

Sponsors & Collaborators

• Livzon Pharmaceutical Group Inc.: lead
• Guangdong Center for Disease Prevention and Control: collaborator
• Simoon Record Pharma Information Consulting Co., Ltd.: collaborator

Study Sites (1)

Guangdong Provincial Center for Disease Control and Prevention

Guangzhou, Guangdong, 511430, China

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Zhang Jikai

  Guangdong Center for Disease Prevention and Control

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: September 20, 2021
• Study Start: August 7, 2021
• Primary Completion: February 18, 2022
• Study Completion: February 18, 2022
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

CN (1)