Immunogenicity and Safety Study of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

NCT ID: NCT05411471

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-08
• Study Completion Date: 2023-06-25

Brief Summary

This is a randomized, open-labeled, Phase IIb clinical trial.The purpose of this study is to evaluate the immunogenicity and safety of the booster vaccine of using one or two doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults above 18 Years Old Who Have Completed Two or Three Doses of mRNA Vaccine or CoronaVac®.

Detailed Description

This is a randomized, open-labeled, Phase IIb clinical trial of 300 participants aged 18 years and above, who have completed two or three doses of mRNA vaccine or CoronaVac® in Hong Kong for at least 90 days after the last dose. After enrollment, the participants will be assigned to 2 groups according to their previous vaccination (mRNA vaccine group and CoronaVac® group) and then each group will be randomly assigned to two study arms at a ratio of 1:1 to receive one or two booster doses of COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Arm 1 (1 dose Omicron Vaccine arm, mRNA vaccine group)

75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain(1200 SOU).

Group Type: EXPERIMENTAL

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Intervention Type: BIOLOGICAL

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Arm 2 (2 doses Omicron Vaccine arm, mRNA vaccine group)

75 participants who have completed two/three doses of mRNA vaccine (prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU).

Group Type: EXPERIMENTAL

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Intervention Type: BIOLOGICAL

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Arm 3 (1 dose Omicron Vaccine arm, CoronaVac® group)

75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive one dose COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (1200 SOU).

Group Type: EXPERIMENTAL

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Intervention Type: BIOLOGICAL

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Arm 4 (2 doses Omicron Vaccine arm, CoronaVac® group)

75 participants who have completed two/three doses of CoronaVac®(prior to this study) will receive two doses COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain (0,28 days)(1200 SOU).

Group Type: EXPERIMENTAL

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

Intervention Type: BIOLOGICAL

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Interventions

COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

The COVID-19 vaccine (Vero cell), Inactivated, Omicron Strain was developed by Sinovac Life Science Ltd.The product is a pre-filled syringe or a vial with an extractable volume of 0.5 mL. The antigen content is 1200 SOU/0.5 mL (6 µg/0.5 mL).

Intervention Type: BIOLOGICAL

Other Intervention Names

COVID-19 Omicron Vaccine

Eligibility Criteria

Inclusion Criteria

• Healthy adults aged 18 years and above, who have received two or three prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) or CoronaVac®, with the last dose given at least 90 days prior to the day of booster vaccination in the present study;
• Evidence of a deep throat saliva (DTS) PCR negative for SARS-COV-2 within 24 hours before enrollment;
• Female participants who have a negative pregnancy test on the day of the first dose of the booster vaccine in the present study, and are not currently breastfeeding;
• The participants are able to understand and sign the informed consent voluntarily before the first dose of booster vaccine in the present study;
• The participants are willing and able to comply with all schedule visits, sample collection, vaccine plan, and other study procedures;
• The participants must be willing to provide verifiable identification (in accordance with the local regulations), has means to be contacted and to contact the investigator during the study.

Exclusion Criteria

• History of confirmed or having evidence showing a current infection of SARS-CoV-2 prior to randomization or vaccination;
• Any prior administration of another investigational coronavirus vaccine or current/planned simultaneous participation in another interventional study to prevent or treat COVID-19;
• Known allergy to vaccines or vaccine ingredients, and serious adverse reactions to vaccines, such as urticaria, dyspnea, angioneurotic edema;
• Serious chronic disease, serious cardiovascular disease, hypertension and diabetes that cannot be controlled by drugs, hepatorenal disease, malignant tumor, etc.;
• Acute central nervous system diseases such as encephalitis/myelitis, acute disseminating encephalomyelitis, and related disorders;
• Receipt of blood/plasma products or immunoglobulins in the past three months before first vaccination in this study;
• Participation in other studies involving study intervention within 30 days prior to first vaccination in this study;
• Receipt of attenuated live vaccines in the past fourteen days prior to each vaccination in this study;
• Receipt of inactivated or subunit vaccines in the past seven days prior to each vaccination in this study;
• Acute exacerbation or presentation of stable chronic diseases (including but not limited to asthma, migraine, gastrointestinal disorder, etc.);
• Acute febrile illness with oral temperature >37.5°C on the day of each vaccination;
• According to the investigator's judgment, the participant has any other factors that might interfere with the results of the clinical trial or pose additional risk to the participant due to participation in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinovac Biotech (Hong Kong) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ivan HUNG Fan Ngai, Doctor

Role: PRINCIPAL_INVESTIGATOR

Gleneagles Hospital HongKong

Locations

Gleneagles Hospital HongKong

Hong Kong, , China

Countries

China

Other Identifiers

PRO-nCOV-2009

Identifier Type: -

Identifier Source: org_study_id