NCT05150496

Brief Summary

This is a randomized, double-blinded, and positive-controlled Phase IIb clinical trial of COVID-19 vaccine (CoronaVac®) manufactured by Sinovac Research \& Development Co., Ltd.The purpose of this study is to evaluate the immunogenicity of using the high (1200SU) or medium (600SU) dose of CoronaVac® as the booster dose.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
640

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Dec 2022

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

2 active sites

Status
suspended

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

First Submitted

Initial submission to the registry

November 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

December 15, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

August 11, 2022

Status Verified

November 1, 2021

Enrollment Period

1 month

First QC Date

November 25, 2021

Last Update Submit

August 9, 2022

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Immunogenicity index-GMT of neutralizing antibodies

    GMT of neutralizing antibodies on 14 days (14-28 days) after the booster dose vaccination

    14 days (14-28 days) after the booster dose vaccination

Secondary Outcomes (8)

  • Immunogenicity index-Seropositivity rate of neutralizing antibodies

    14 days (14-28 days) after the booster dose vaccination

  • Immunogenicity index-GMI of neutralizing antibodies

    14 days (14-28 days) after the booster dose vaccination

  • Immunogenicity index-The seropositivity rate of neutralizing antibody

    At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

  • Immunogenicity index-GMT of neutralizing antibody

    At 3 (±2 weeks) and 6 (±2 weeks) months after the booster dose vaccination

  • Safety index-Occurrence, intensity, duration, and relationship of solicited local and systemic AEs

    7 days following the booster dose vaccination

  • +3 more secondary outcomes

Other Outcomes (3)

  • Immunogenicity index-The seropositivity rate of neutralizing antibodies

    Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination

  • Immunogenicity index-GMT of neutralizing antibodies

    Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination

  • Immunogenicity index-GMI of neutralizing antibodies

    Before vaccination, 14 days (14-28 days) , 3-month (±2 weeks), and 6-month (±2 weeks) after the booster dose vaccination

Study Arms (4)

Two doses CoronaVac® + one dose medium-dose CoronaVac®

EXPERIMENTAL

200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using medium-dose CoronaVac®3-8 months after their second dose

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

Two doses CoronaVac® + one dose high-dose CoronaVac®

EXPERIMENTAL

200 participants who were vaccinated with CoronaVac® will be given one dose booster immunization using high-dose CoronaVac® 3-8 months after their second dose

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

Two doses Comirnaty + one dose medium-dose CoronaVac®

EXPERIMENTAL

120 participants were vaccinated with Comirnaty will be given one dose booster immunization using medium-dose CoronaVac® 6-8 months after their second dose

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

Two doses Comirnaty + one dose high-dose CoronaVac®

EXPERIMENTAL

120 participants were vaccinated with Comirnaty will be given one dose booster immunization using one dose high-dose CoronaVac® 6-8 months after their second dose

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

Interventions

Medium-dose COVID-19 Vaccine(Vero Cell),InactivatedBIOLOGICAL

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®
Two doses Comirnaty + one dose medium-dose CoronaVac®Two doses CoronaVac® + one dose medium-dose CoronaVac®
High-dose COVID-19 Vaccine(Vero Cell),InactivatedBIOLOGICAL

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

Also known as: High-dose CoronaVac®
Two doses Comirnaty + one dose high-dose CoronaVac®Two doses CoronaVac® + one dose high-dose CoronaVac®

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 2 prior doses of inactivated COVID-19 vaccine (CoronaVac®) or mRNA COVID-19 vaccine (Comirnaty), with the second dose given 3-8 months (for CoronaVac® recipients) and 6-8 months (for Comirnaty recipients) prior to the day of booster vaccination in the present study;
  • Antigen rapid testing negative at the day of enrollment on site or with a PCR negative result within 72 hours before enrollment;
  • The participants are able to understand and sign the informed consent voluntarily;
  • Female participants who have a negative pregnancy test on the day of vaccination, and not currently breastfeeding;
  • The participants are planning to be living in Turkey for the following 1 year after attending this study;
  • 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 currently with the 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 3 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 14 days prior to vaccination in this study;
  • Receipt of inactivated or subunit vaccines in the past 7 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 axillary temperature \>37.5°C on the day of vaccination; enrollment could be considered if the fever is absent for 72 hours prior to 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 (2)

Hacettepe University Faculty of Medicine, Department of Internal Diseases / Infectious Diseases and Clinical Microbiology Unit

Ankara, 6230, Turkey (Türkiye)

Location

Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases

Ankara, 6800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

sinovac COVID-19 vaccine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Enes Seyda Şahiner, Doctor

    Republic of Turkey Ministry of Health Ankara City Hospital Department of Internal Diseases

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 9, 2021

Study Start

December 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

August 11, 2022

Record last verified: 2021-11

Locations

TU(2)