A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine

NCT05239806 | Unknown Phase 2

• 1 other identifier: SCTV01C/E-01-In-LAO-1
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 infection; Vaccine

Outcome Measures

Primary Outcomes (4)

• GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28.

  Day 28 after the study vaccination

• GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28.

  Day 28 after the study vaccination

• GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208.

  Day 208 after the study vaccination

• GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208.

  Day 208 after the study vaccination

Secondary Outcomes (11)

• Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208.

  Day 28 and D208 after the study vaccination

• Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28.

  Day 28 after the study vaccination

• Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28.

  Day 28 after the study vaccination

• Seroresponse rates of neutralizing antibodies to Delta variant on Day 208.

  Day 208 after the study vaccination

• Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208.

  Day 208 after the study vaccination

Study Arms (4)

SCTV01C

EXPERIMENTAL

Participants will receive one dose of SCTV01C on Day 0 and one dose of SCTV01E on Day 180.

Biological: SCTV01C; Biological: SCTV01E

SCTV01E

EXPERIMENTAL

Participants will receive one dose of SCTV01E on Day 0 and one dose of SCTV01E on Day 180.

Biological: SCTV01E

Sinopharm inactivated COVID-19 vaccine

ACTIVE COMPARATOR

Participants will receive one dose of Sinopharm inactivated COVID-19 vaccine on Day 0 and one dose of SCTV01E on Day 180.

Biological: Sinopharm inactivated COVID-19 vaccine; Biological: SCTV01E

Comirnaty

ACTIVE COMPARATOR

Participants will receive one dose of Comirnaty on Day 0 and one dose of SCTV01E on Day 180.

Biological: Comirnaty; Biological: SCTV01E

Interventions

SCTV01C BIOLOGICAL

Day 0; intramuscular injection

SCTV01C

SCTV01E BIOLOGICAL

Day 0; intramuscular injection

SCTV01E

Sinopharm inactivated COVID-19 vaccine BIOLOGICAL

Day 0; intramuscular injection

Sinopharm inactivated COVID-19 vaccine

Comirnaty BIOLOGICAL

Day 0; intramuscular injection

Comirnaty

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥12 years old when signing ICF;
• Participants who were fully vaccinated with inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine), and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months;
• The participant and/or his legal guardian and/or his entrusted person 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 legal guardian and/or his entrusted person 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 1st study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

You may not qualify if:

• 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix), 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 (exception for Sinopharm inactivated COVID-19 vaccine) ;
• Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

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

Central Study Contacts

Min Ke

CONTACT

+86 18501160269; min_ke@sinocelltech.com

Yongpan Fu

CONTACT

+86 18612320378; yongpan_fu@sinocelltech.com

Study Design

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

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 15, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: April 11, 2022

Record last verified: 2022-02