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

NCT05323461 | Unknown Phase 3

• 1 other identifier: SCTV01C-E-01-UAE-1
• Study Type: interventional
• Target: 1,800
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2; Vaccine

Outcome Measures

Primary Outcomes (2)

• GMT of nAb against Delta variant on Day 28

  Day 28 after the study vaccination

• GMT of nAb against Omicron variant on Day 28

  Day 28 after the study vaccination

Secondary Outcomes (10)

• GMT of nAb against Delta variant on Day 180

  Day 180 after the study vaccination

• GMT of nAb against Omicron variant on Day 180

  Day 180 after the study vaccination

• Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28

  Day 28 after the study vaccination

• Seroresponse rates of nAb to Delta variant on Day 28.

  Day 28 after the study vaccination

• Seroresponse rates of nAb to Omicron variant on Day 28.

  Day 28 after the study vaccination

Study Arms (6)

Cohort 1: SCTV01C

EXPERIMENTAL

one dose of SCTV01C on D0

Biological: SCTV01C

Cohort 1: SCTV01E

EXPERIMENTAL

one dose of SCTV01E on D0

Biological: SCTV01E

Cohort 1: Active comparator

ACTIVE COMPARATOR

one dose of Sinopharm inactivated COVID-19 vaccine on D0

Biological: Sinopharm inactivated COVID-19 vaccine

Cohort 2: SCTV01C

EXPERIMENTAL

one dose of SCTV01C on D0

Biological: SCTV01C

Cohort 2: SCTV01E

EXPERIMENTAL

one dose of SCTV01E on D0

Biological: SCTV01E

Cohort 2: Active comparator

ACTIVE COMPARATOR

one dose of Comirnaty on D0

Biological: Comirnaty

Interventions

SCTV01C BIOLOGICAL

intramuscular injection

Cohort 1: SCTV01C; Cohort 2: SCTV01C

SCTV01E BIOLOGICAL

intramuscular injection

Cohort 1: SCTV01E; Cohort 2: SCTV01E

Sinopharm inactivated COVID-19 vaccine BIOLOGICAL

intramuscular injection

Cohort 1: Active comparator

Comirnaty BIOLOGICAL

intramuscular injection

Cohort 2: Active comparator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years old when signing ICF;
• 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.
• 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;
• The participant and/or his legally acceptable representative have the ability to read, understand, and fill in record cards;
• 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;
• 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.

You may not qualify if:

• For Subgroup 1 in Cohort 1 only: Previously diagnosed with COVID-19.
• Presence of fever within 3 days before the study vaccination;
• 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;
• A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
• A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
• 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.;
• 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;
• Patients on antituberculosis therapy;
• 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;
• Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
• Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
• Participants who received other investigational drugs within 1 month before the study vaccination;
• Participants who is at the acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
• Participants received other drugs or vaccines used to prevent COVID-19, but participants previously received Sinopharm inactivated COVID-19 vaccine, Comirnaty or mRNA-1273 will not be excluded;
• Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Al Kuwait Hospital (Al Baraha Hospital)

Dubai, United Arab Emirates

Location

Related Publications (2)

• Hannawi S, Yan L, Saifeldin L, Abuquta A, Alamadi A, Mahmoud SA, Hassan A, Zhang M, Gao C, Chen Y, Gai W, Xie L. Safety and immunogenicity of multivalent SARS-CoV-2 protein vaccines: a randomized phase 3 trial. EClinicalMedicine. 2023 Sep 8;64:102195. doi: 10.1016/j.eclinm.2023.102195. eCollection 2023 Oct.

  PMID: 37731938 DERIVED

• Wang R, Huang H, Yu C, Sun C, Ma J, Kong D, Lin Y, Zhao D, Zhou S, Lu J, Cao S, Zhang Y, Luo C, Li X, Wang Y, Xie L. A spike-trimer protein-based tetravalent COVID-19 vaccine elicits enhanced breadth of neutralization against SARS-CoV-2 Omicron subvariants and other variants. Sci China Life Sci. 2023 Aug;66(8):1818-1830. doi: 10.1007/s11427-022-2207-7. Epub 2022 Dec 30.

  PMID: 36598621 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

SCTV01C vaccine; BNT162 Vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2022
• First Posted: April 12, 2022
• Study Start: May 30, 2022
• Primary Completion: October 28, 2022
• Study Completion: May 1, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

AE (1)