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

COVID-19 Pandemic Clinical Trial

— COVID-19  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05583357
• Other study ID #: V-01D-351-Booster-03
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: August 15, 2022
• Est. completion date: August 10, 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, blind endpoint evaluation, exploratory clinical study to evaluate the safety and immunogenicity of bivalent vaccine V-01D-351 as a booster.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: August 10, 2023
• Est. primary completion date: September 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Biological:
• V-01D-351
One dose of V-01D-351 on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
• V-01D-351
One dose of V-01D-351 on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago
• CoronaVac
One dose of CoronaVac on participants received 2 doses of inactivated vaccine (CoronaVac) 6-15 months ago
• CoronaVac
One dose of CoronaVac on participants received 3 doses of inactivated vaccine (CoronaVac) 5-9 months ago

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	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	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
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	7 days, 14 days, 28 days, 3 months, 6 months and 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	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Secondary	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
Secondary	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
Secondary	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
Secondary	Specific cytokine secretion levels	Specific cytokine secretion levels such as IFN-?	7 days, 14 days, 28 days, 3 months, 6 months and 12 months after vaccination
Secondary	AEs	Observe the AEs occurs at different time point after vaccination	30 minutes, 0-7 days, 0-28 days after vaccination
Secondary	SAE and AESI	Observe the SAE and AESI after vaccination	Within 12 months after vaccination