Immunogenicity and Safety Study of the 3rd Booster Dose Using the High or Medium Dose of Inactivated Vaccine in Healthy Adults in in Hong Kong

COVID-19 Clinical Trial

Official title:

A Phase IIb, Randomized, Double-Blinded Trial to Evaluate the Immunogenicity and Safety Study of the Booster Dose Using the High or Medium Dose of COVID- 19 Vaccine (Vero Cell), Inactivated in Healthy Adults Who Have Completed Two Doses of mRNA Vaccine in Hong Kong

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05254236
• Other study ID #: PRO-nCOV-2004
• Status: Withdrawn
• Phase: Phase 2
• Start date: February 10, 2022
• Est. completion date: March 10, 2022

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, double-blinded, Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research & Development Co., Ltd.The purpose of this study is to evaluate to evaluate the changes in immunogenicity before and after the booster vaccine using the high (1200 SU) or medium (600 SU) dose of COVID-19 Vaccine (Vero Cell), Inactivated.

Description:

This is a randomized, double-blinded, Phase IIb clinical trial of 150 participants aged 18 years and above, who have completed two doses of mRNA COVID-19 vaccine as the primary vaccination for at least six months after the second dose. After enrollment, participants will be randomly assigned into two study arms at a ratio of 1:1 to receive a booster of one dose of medium-dose (600 SU) or one dose of high-dose (1200 SU) COVID-19 Vaccine.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 10, 2022
• Est. primary completion date: March 10, 2022
• 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 prior doses of mRNA COVID-19 vaccine (Comirnaty®, made by BioNTech/Pfizer) as the primary vaccination, with the second dose given at least 180 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 vaccination, and not currently breastfeeding;
• The participants are able to understand and sign the informed consent voluntarily;
• 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;
• 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 vaccination in this study;
• Participation in other studies involving study intervention within 30 days prior to vaccination in this study;
• Receipt of attenuated live vaccines in the past fourteen days prior to vaccination in this study;
• Receipt of inactivated or subunit vaccines in the past seven days prior to 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 >37.5C on the day of 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 (Medium-dose)
Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection
• COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)
High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Locations

Country	Name	City	State
China	Gleneagles Hospital HongKong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Sinovac Research and Development Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the high dose	Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the high dose .	28 days after the booster dose vaccination
Primary	Immunogenicity index-Geometric mean fold rise (GMFR) of neutralization antibody titre in the medium dose	Geometric mean fold rise (GMFR) of neutralization antibody titre from baseline to 28 days post the booster vaccine in the medium dose .	28 days after the booster dose vaccination
Secondary	Immunogenicity index-the seropositivity rate of neutralizing antibody in the high dose	The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose	28 days after the booster dose vaccination
Secondary	Immunogenicity index-the seropositivity rate of neutralizing antibody in the medium dose	The seropositivity rate of neutralizing antibody on day 28 after the booster dose vaccination in the high dose	28 days after the booster dose vaccination
Secondary	Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT) in the medium dose	Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the high dose	28 days after the booster dose vaccination
Secondary	Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT)in the medium dose	Geometric mean of neutralizing antibody titer (GMT) on Day 28 after the booster dose vaccination in the medium dose	28 days after the booster dose vaccination
Secondary	Immunogenicity index-The seropositivity rate of neutralizing antibody in the high dose	The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the high dose	3 months after the booster dose vaccination
Secondary	Immunogenicity index-The seropositivity rate of neutralizing antibody in the medium dose	The seropositivity rate of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose	3 months after the booster dose vaccination
Secondary	Immunogenicity index-The seropositivity rate in the high dose	The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the high dose	6 months after the booster dose vaccination
Secondary	Immunogenicity index-The seropositivity rate in the medium dose	The seropositivity rate of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose	6 months after the booster dose vaccination
Secondary	Immunogenicity index-GMT of neutralizing antibody in the high dose	GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose	3 months after the booster dose vaccination
Secondary	Immunogenicity index-the GMT of neutralizing antibody in the high dose	GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose	6 months after the booster dose vaccination
Secondary	Immunogenicity index-GMT of neutralizing antibody in the medium dose	GMT of neutralizing antibody at 3 months after the booster dose vaccination in the medium dose	3 months after the booster dose vaccination
Secondary	Immunogenicity index-the GMT of neutralizing antibody in the medium dose	GMT of neutralizing antibody at 6 months after the booster dose vaccination in the medium dose	6 months after the booster dose vaccination
Secondary	Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs	Occurrence, intensity, duration, and relationship of solicited local and systemic AEs for seven days following the booster dose vaccination and of unsolicited AEs for 28 days post booster vaccination.	28 days after the booster dose vaccination
Secondary	Safety index-Occurrence and relationship of SAEs	Occurrence and relationship of SAEs within 12 months post booster vaccination.	Within 12 months post booster vaccination
Secondary	Safety index-Occurrence and relationship of AESI	Occurrence and relationship of AESI within 12 months post booster vaccination.	Within 12 months post booster vaccination