Exploratory Clinical Study to Evaluation of the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 (COVID-19)

A Single Center, Randomized, Open-labeled, Blind Endpoint Evaluation, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01D-351 as a Booster Dose in Participants Aged 18 Years and Older Vaccinated 2-dose or 3-dose Inactivated COVID-19 Vaccine

It is a single center, randomized, open-labeled, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.

Study Overview

• Status: Active, not recruiting
• Conditions: COVID-19 Pandemic
• Intervention / Treatment: Biological: V-01D-351; Biological: V-01D-351; Biological: CoronaVac; Biological: CoronaVac

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Shaoguan, Guangdong, China, 512000
      • Shaoguan Hospital of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults aged 18 years and older at time of consent, male or female;
• Normal body temperature;

• Meet either of the following conditions:

  1. Received completed primary immunization of 2 doses of CoronaVac 6-15 months ago;
  2. Received completed 3 doses of CoronaVac 5-9 months ago;
• Female participants who are not pregnant at the time of enrollment (urine pregnancy test is negative), nor during lactating; and has no birth plan and agree to take effective contraception in 7 months after enrollment; and took effective and acceptable contraceptive methods in the previous 2 weeks before the enrollment;
• Be able and willing to complete the study during the entire study and follow-up period;
• Participants who have the ability to understand the study process, sign the informed consent form voluntarily , and be able to comply with the requirements of the clinical study protocol.

Exclusion Criteria:

• Serious chronic diseases or uncontrolled diseases;
• Uncontrolled neurological disorders, epilepsy;
• Received any inactivated vaccine within 1 week or received any attenuated vaccines within 4 weeks;
• Patients with congenital or acquired immunodeficiency;
• History of severe allergy or be allergic to any components of the test vaccines;
• History of hereditary hemorrhagic tendency or coagulation dysfunction;
• Patients with malignant tumors and other patients have a life expectancy less than 1 year;
• Refuse to sign the informed consent form or inability to complete follow-ups as required by the protocol;
• History of previous COVID-19 infection;
• Pregnant or breastfeeding women, or females of childbearing potential who not agree to or able to take effective and acceptable contraceptive methods during the study;
• Participants who have participated in other clinical trials within 3 months or are participating in other clinical trials;
• Those considered by the investigator as inappropriate to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1	Biological: V-01D-351; One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago; Biological: V-01D-351; One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Experimental: Cohort 2	Biological: V-01D-351; One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago; Biological: V-01D-351; One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Active Comparator: Cohort 3	Biological: CoronaVac; One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago; Biological: CoronaVac; One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
Active Comparator: Cohort 4	Biological: CoronaVac; One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago; Biological: CoronaVac; One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing antibody GMT of Omicron BA.5	Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)	28 days after vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neutralizing antibody GMT of other SARS-CoV-2 variants	Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)	Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)	Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Total IgG antibody level	Total IgG antibody level of SARS-CoV-2	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Spike protein antibody level	Antibody level of anti-SARS-CoV-2 spike protein	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
RBD antibody level	Anti-SARS-CoV-2 RBD antibody level	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Specific cytokine secretion levels	Specific cytokine secretion levels such as IFN-γ	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
AEs	Observe the AEs occurs at different time point after vaccination	30 minutes, 0-7 days, 0-28 days after vaccination
SAE and AESI	Observe the SAE and AESI after vaccination	Within 12 months after vaccination

Collaborators and Investigators

• Sponsor: Livzon Pharmaceutical Group Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2022
• Primary Completion (Actual): September 13, 2022
• Study Completion (Anticipated): August 10, 2023

Study Registration Dates

• First Submitted: October 13, 2022
• First Submitted That Met QC Criteria: October 13, 2022
• First Posted (Actual): October 17, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: V-01D-351-Booster-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No