We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05411471
Recruitment Status : Recruiting
First Posted : June 9, 2022
Last Update Posted : July 6, 2022
Sponsor:
Information provided by (Responsible Party):
Sinovac Biotech Co., Ltd ( Sinovac Biotech (Hong Kong) Limited )

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®.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: COVID-19 Vaccine (Vero Cell), Inactivated, Omicron Strain Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 8, 2022
Estimated Primary Completion Date : March 8, 2023
Estimated Study Completion Date : March 8, 2023

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: COVID-19 Omicron Vaccine




Primary Outcome Measures :
  1. Geometric mean of neutralization antibody titre (GMT) [ Time Frame: Day 14 after the last booster dose ]
    Geometric mean of neutralization antibody titre (GMT) on Day 14 after the last booster dose against the Omicron variant in different groups

  2. Occurrence, intensity, duration, and relationship of solicited local and systemic AEs [ Time Frame: 28 days post booster vaccination ]
    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


Secondary Outcome Measures :
  1. Seroconversion rate of neutralization antibody [ Time Frame: Day 14 after the last booster dose ]
    Seroconversion rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups

  2. Seropositivity rate of neutralization antibody [ Time Frame: Day 14 after the last booster dose ]
    Seropositivity rate of neutralization antibody against the omicron variant on Day 14 after the last booster dose in different groups

  3. Occurrence and relationship of SAEs [ Time Frame: within 6 months post booster vaccination ]
    Occurrence and relationship of SAEs within 6 months post booster vaccination.


Other Outcome Measures:
  1. Seropositive rate of neutralizing antibody [ Time Frame: At 90 days and 183 days after one or two doses of booster vaccination ]
    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

  2. GMT of neutralizing antibody [ Time Frame: At 90 days and 183 days after one or two doses of booster vaccination ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05411471


Contacts
Layout table for location contacts
Contact: Ivan HUNG Fan Ngai, Doctor 852 3153 9000 ivanhung@hku.hk

Locations
Layout table for location information
China, HongKong
Gleneagles Hospital HongKong Recruiting
Wong Chuk Hang, HongKong, China
Contact: Ivan HUNG Fan Ngai, Doctor    852 2255 4049    ivanhung@hku.hk   
Sponsors and Collaborators
Sinovac Biotech (Hong Kong) Limited
Investigators
Layout table for investigator information
Principal Investigator: Ivan HUNG Fan Ngai, Doctor Gleneagles Hospital HongKong
Layout table for additonal information
Responsible Party: Sinovac Biotech (Hong Kong) Limited
ClinicalTrials.gov Identifier: NCT05411471    
Other Study ID Numbers: PRO-nCOV-2009
First Posted: June 9, 2022    Key Record Dates
Last Update Posted: July 6, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs