A Preliminary Exploratory Study to Evaluate the Safety and Immunogenicity of Omicron Variant Bivalent Vaccine V-01-B5

COVID-19 Pandemic Clinical Trial

— COVID-19  

Official title:

A Single Center, Randomized, Open-labeled, Exploratory Clinical Study to Evaluate the Safety and Immunogenicity of Bivalent Vaccine V-01-B5 as a Booster Dose in Participants Aged 18-59 Years Vaccinated 3-dose Inactivated COVID-19 Vaccine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05585567
• Other study ID #: V-01-B5- Booster-01
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 16, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: October 2022
• Source: Livzon Pharmaceutical Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is a single center, randomized, open-labeled, exploratory clinical study to evaluate the safety and immunogenicity of Recombinant SARS-CoV-2 Fusion Protein bivalent Vaccine V-01-B5 as a second booster in adults aged 18-59 years after vaccinated with 3-dose of inactivated vaccines.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: September 11, 2023
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

Inclusion Criteria:

• Adults aged 18 -59 years old at time of consent, male or female;
• Normal body temperature;
• Participants who have completed 3-dose regimen of inactive vaccination (CoronaVac) against SARS-CoV-2 wild type in the past 5-9 months;
• 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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Biological:
• V-01/V-01-B5
Contains 10µg of V-01 and 10µg of V-01-B5
• V-01-351/V-01-B5
Contains 10µg of V-01-351 and 10µg of V-01-B5
• V-01
Contains 10µg of V-01

Locations

Country	Name	City	State
China	Shaoguan Hospital of Chinese Medicine	Shaoguan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Livzon Pharmaceutical Group Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse Event (AE)	Observe the AEs occurs at different time point after vaccination	30 minutes after vaccination
Primary	AEs	Observe the AEs occurs at different time point after vaccination	0-7 days after vaccination
Primary	AEs	Observe the AEs occurs at different time point after vaccination	0-28 days after vaccination
Primary	Serious adverse event (SAE) and adverse event of special interest (AESI)	Observe the SAE and AESI after vaccination	Within 12 months after vaccination
Primary	Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5	Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)	28 days after vaccination
Secondary	Neutralizing antibody GMT of other SARS-CoV-2 variants	Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)	Until 12 months after vaccination
Secondary	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	Until 12 months after vaccination
Secondary	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	Until 12 months after vaccination
Secondary	Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level	Anti-SARS-CoV-2 RBD antibody level after vaccination	Until 12 months after vaccination