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A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines | Clinical Trials | Clareo Health

UNKNOWNPHASE3

A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines

A Randomized, Double-blind, and Positive-controlled Phase III Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C (A Bivalent SARS-CoV-2 Trimeric Spike Protein Vaccine) and SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years Previously Vaccinated With Either Inactivated or mRNA COVID-19 Vaccine or Previously Diagnosed With COVID-19

NCT05323461•Sinocelltech Ltd.

View on ClinicalTrials.gov

Summary

The study is a randomized, double-blind, and positive-controlled Phase III booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with either one dose of Sinopharm inactivated COVID-19 vaccine (Cohort 1) or one dose of Comirnaty (Cohort 2).

Detailed Description

Approximately 1,800 participants aged 18 years old and above will be enrolled in this study. 1,350 participants who previously received Sinopharm inactivated COVID-19 vaccine will be enrolled to Cohort 1. 450 participants who previously received mRNA COVID-19 vaccine or previously diagnosed with COVID-19 will be enrolled to Cohort 2.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female aged ≥18 years old when signing ICF;
•2. For Subgroup 1 in Cohort 1: Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine. The interval between the date of last dose and the date of this study vaccination should be 3 to 24 months.
•For Subgroup 2 in Cohort 1: 1) Participants who were previously vaccinated with 2 or 3 doses of Sinopharm inactivated COVID-19 vaccine, with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 dose of Sinopharm inactivated COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
•For Cohort 2: 1) Participants who were previously vaccinated with 2 or 3 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273), with or without COVID-19 history; or 2) Participants who were previously vaccinated with 1 doses of mRNA COVID-19 vaccine (Comirnaty or mRNA-1273) and previously diagnosed with COVID-19; or 3) Participants who were previously not vaccinated with any COVID-19 vaccine and previously diagnosed with COVID-19. The interval between the date of last dose/COVID-19 diagnosis and the date of this study vaccination should be 3 to 24 months.
•3. The participant and/or his legally acceptable representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial;
•4. The participant and/or his legally acceptable representative have the ability to read, understand, and fill in record cards;
•5. Healthy participants or participants with pre-existing medical conditions who are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis that meet the described criteria. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment;
•6. Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion Criteria

•1. For Subgroup 1 in Cohort 1 only: Previously diagnosed with COVID-19.
•2. Presence of fever within 3 days before the study vaccination;
•3. A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease corresponding use of immunosuppressants;
•4. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
•5. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
•6. Immunocompromised patients suffering from immunodeficiency diseases, important organ diseases, immune diseases (including Guillain-Barre Syndrome \[GBS\], systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy caused by any circumstances, and other immune diseases that may have an impact on immune response in the investigator's opinion), etc.;
•7. Long-term use of immunosuppressant therapy or immunomodulatory drugs for ≥14 days within the first six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
•8. Patients on antituberculosis therapy;
•9. Presence of severe or uncontrollable cardiovascular diseases, or severe or uncontrollable disorders related to endocrine system, blood and lymphatic system, liver and kidney, respiratory system, metabolic and skeletal systems, or malignancies (skin basal cell carcinoma and carcinoma in-situ of cervix are exceptions and will not be excluded), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
•10. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
+11 more criteria

Locations (1)

Al Kuwait Hospital (Al Baraha Hospital)

Dubai, United Arab Emirates

Key Dates

Start Date

May 30, 2022

Primary Completion Date

October 28, 2022

Completion Date

May 1, 2023

Last Updated

April 10, 2023

Enrollment

1,800

ESTIMATED participants

Conditions

COVID-19SARS-CoV-2 Infection

Interventions

SCTV01C

BIOLOGICAL

SCTV01E

BIOLOGICAL

Sinopharm inactivated COVID-19 vaccine

BIOLOGICAL

Comirnaty

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 10, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Immunogenicity and Safety of Two Recombinant Protein COVID-19 Vaccines in Population Aged ≥18 Years as Booster Vaccines

Inclusion Criteria

Exclusion Criteria

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