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

Early Phase 1

Active, not recruiting

• Conditions: COVID-19 Pandemic
• Interventions: Biological: V-01; Biological: V-01-351/V-01-B5; Biological: V-01/V-01-B5

• Registration Number: NCT05585567
• Lead Sponsor: Livzon Pharmaceutical Group Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Status Verified: 2022-10
• Study First Submitted: 2022-10-13
• Primary Completion: 2022-10-14
• Study First Submitted QC: 2022-10-16
• Study First Posted: 2022-10-19
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Study Completion: 2023-09-11

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
V-01 group	V-01	One dose of V-01
V-01-351/V-01-B5 group	V-01-351/V-01-B5	One dose of V-01-351/V-01-B5
V-01/V-01-B5 group	V-01/V-01-B5	One dose of V-01/V-01-B5

Primary Outcome Measures

Name	Time	Method
Adverse Event (AE)	30 minutes after vaccination	Observe the AEs occurs at different time point after vaccination
Serious adverse event (SAE) and adverse event of special interest (AESI)	Within 12 months after vaccination	Observe the SAE and AESI after vaccination
AEs	0-28 days after vaccination	Observe the AEs occurs at different time point after vaccination
Neutralizing antibody geometric mean titer (GMT) of Omicron BA.5	28 days after vaccination	Neutralizing antibody GMT of the most prevalent SARS-CoV-2 variant (Omicron BA.5)

Secondary Outcome Measures

Name	Time	Method
Neutralizing antibody GMT of other SARS-CoV-2 variants	Until 12 months after vaccination	Neutralizing antibody GMT of Delta variant and Omicron variants (BA.2, BA.4, BA.5)
Neutralizing antibody titer of other SARS-CoV-2 variants (SVNT)	Until 12 months after vaccination	Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by SVNT
Anti-SARS-CoV-2 receptor-binding domain (RBD) antibody level	Until 12 months after vaccination	Anti-SARS-CoV-2 RBD antibody level after vaccination
Neutralizing antibody titer of other SARS-CoV-2 variants (MRNT)	Until 12 months after vaccination	Neutralizing antibody titer of Delta variant and Omicron variants (BA.2, BA.4, BA.5) by MRNT

Trial Locations

Locations (1)

Shaoguan Hospital of Chinese Medicine; 🇨🇳 Shaoguan, Guangdong, China