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

A Phase IIb, Randomized, Open-labeled Trial to Evaluate the Immunogenicity and Safety of One or Two Doses of Booster Vaccine With the COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain in Adults in Hong Kong

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®.

Study Overview

• Status: Completed
• Conditions: COVID-19
• Intervention / Treatment: Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain

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.

• Study Type: Interventional
• Enrollment (Actual): 221
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Ivan HUNG Fan Ngai, Doctor; Phone Number: 852 3153 9000; Email: ivanhung@hku.hk

Study Locations

• China
  • Hong Kong, China
    • Gleneagles Hospital HongKong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Biological: 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).; Other Names: COVID-19 Omicron Vaccine
Experimental: 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).	Biological: 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).; Other Names: COVID-19 Omicron Vaccine
Experimental: 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).	Biological: 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).; Other Names: COVID-19 Omicron Vaccine
Experimental: 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).	Biological: 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).; Other Names: COVID-19 Omicron Vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geometric mean of neutralization antibody titre (GMT)	Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups	Day 14 after the last booster dose
Occurrence, intensity, duration, and relationship of solicited local and systemic AEs	Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for 7 days following each booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination	28 days post booster vaccination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate of neutralization antibody	Seroconversion rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups	Day 14 after the last booster dose
Seropositivity rate of neutralization antibody	Seropositivity rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups	Day 14 after the last booster dose
Occurrence and relationship of SAEs	Occurrence and relationship of SAEs within 6 months post booster vaccination.	within 6 months post booster vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seropositive rate of neutralizing antibody	Seropositive rate of neutralizing antibody to SARS-CoV-2 at 90 days and 183 days after one or two doses of booster vaccination in different groups	At 90 days and 183 days after one or two doses of booster vaccination
GMT of neutralizing antibody	GMT of neutralizing antibody to SARS-CoV-2 at 90 days and 183 days after one or two doses of booster vaccination in different groups	At 90 days and 183 days after one or two doses of booster vaccination

Collaborators and Investigators

• Sponsor: Sinovac Biotech (Hong Kong) Limited
• Investigators: Principal Investigator: Ivan HUNG Fan Ngai, Doctor, Gleneagles Hospital HongKong

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): June 25, 2023
• Study Completion (Actual): June 25, 2023

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 9, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: PRO-nCOV-2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No