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

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05411471
• Other study ID #: PRO-nCOV-2009
• Status: Completed
• Phase: Phase 2
• Start date: June 8, 2022
• Est. completion date: June 25, 2023

Study information

• Verified date: September 2023
• Source: Sinovac Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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®.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 221
• Est. completion date: June 25, 2023
• Est. primary completion date: June 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19

Intervention

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).

Locations

Country	Name	City	State
China	Gleneagles Hospital HongKong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Biotech (Hong Kong) Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Occurrence and relationship of SAEs	Occurrence and relationship of SAEs within 6 months post booster vaccination.	within 6 months post booster vaccination