NCT05254236

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2022

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2022

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

28 days

First QC Date

February 20, 2022

Last Update Submit

September 21, 2023

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (15)

  • Immunogenicity index-the seropositivity rate of neutralizing antibody in the high dose

    28 days after the booster dose vaccination

  • Immunogenicity index-the seropositivity rate of neutralizing antibody in the medium dose

    28 days after the booster dose vaccination

  • Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT) in the medium dose

    28 days after the booster dose vaccination

  • Immunogenicity index-Geometric mean of neutralizing antibody titer (GMT)in the medium dose

    28 days after the booster dose vaccination

  • Immunogenicity index-The seropositivity rate of neutralizing antibody in the high dose

    3 months after the booster dose vaccination

  • +10 more secondary outcomes

Study Arms (2)

Medium-dose arm

EXPERIMENTAL

75 participants vaccinated two doses of mRNA vaccine(prior to this study) will be given one dose booster immunization using medium-dose COVID-19 Vaccine (Vero Cell), Inactivated

Biological: COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose)

High-dose arm

EXPERIMENTAL

75 participants vaccinated two doses of mRNA vaccine(prior to this study) will be given one dose booster immunization using high-dose COVID-19 Vaccine (Vero Cell), Inactivated

Biological: COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)

Interventions

COVID-19 Vaccine (Vero Cell), Inactivated (Medium-dose)BIOLOGICAL

Medium-dose COVID-19 Vaccine(Vero Cell),Inactivated: 600SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

Also known as: Medium-dose CoronaVac®
Medium-dose arm
COVID-19 Vaccine (Vero Cell), Inactivated (High-dose)BIOLOGICAL

High-dose COVID-19 Vaccine(Vero Cell),Inactivated:1200SU inactivated SARS-CoV-2 virus in 0.5 mL of aluminium hydroxide solution per injection

High-dose arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gleneagles Hospital HongKong

Hong Kong, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Ivan Fan Ngai HUNG, Doctor

    Gleneagles Hospital HongKong

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

February 24, 2022

Study Start

February 10, 2022

Primary Completion

March 10, 2022

Study Completion

March 10, 2022

Last Updated

September 22, 2023

Record last verified: 2023-09

Locations

CN(1)