A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E in Population Aged ≥18 Years Previously Fully Vaccinated With mRNA COVID-19 Vaccine

NCT05238441 | Unknown Phase 2

• 1 other identifier: SCTV01E-01-mRNA-JOR-1
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study is to evaluate the immunogenicity and safety of SCTV01E in participants aged ≥18 years and previously fully immunized with mRNA COVID-19 vaccine.

Conditions

COVID-19; Sars-CoV-2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (2)

• GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D28.

  Day 28 after the study vaccination

• GMT of neutralizing antibodies against Delta (B.1.617.2) variant on D208.

  Day 208 after the study vaccination

Secondary Outcomes (10)

• GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D28.

  Day 28 after the study vaccination

• GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on D208.

  Day 208 after the study vaccination

• Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on D28 and D208.

  Day 28 and Day 208 after the study vaccination

• Seroresponse rates of neutralizing antibodies of Delta variant from on D28.

  Day 28 after the study vaccination

• Seroresponse rates of neutralizing antibodies of Omicron variant from on D28.

  Day 28 after the study vaccination

Study Arms (3)

SCTV01E and SCTV01E

EXPERIMENTAL

SCTV01E on D0 and D180

Biological: SCTV01E

Comirnaty and SCTV01E

ACTIVE COMPARATOR

Comirnaty on D0 and SCTV01E on D180

Biological: Comirnaty; Biological: SCTV01E

Comirnaty and Comirnaty

ACTIVE COMPARATOR

Comirnaty on D0 and D180

Biological: Comirnaty

Interventions

SCTV01E BIOLOGICAL

D0; intramuscular injection

SCTV01E and SCTV01E

Comirnaty BIOLOGICAL

D0; intramuscular injection

Comirnaty and Comirnaty; Comirnaty and SCTV01E

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;
• Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna) and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months.
• The participant can sign the written ICF (by applying his / her signature or fingerprint "for illiterate subject"), 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 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;
• A positive result of nucleic acid test for SARS-CoV-2 during the screening period;
• 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 Comirnaty from Pfizer or mRNA-1273 from Moderna will not be excluded;

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

Zibin Luo

CONTACT

+86 13751891764; zibin_luo@sinocelltech.com

Yu Sun

CONTACT

+86 13816901291; yu_sun@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 11, 2022
• First Posted: February 14, 2022
• Study Start: March 20, 2022
• Primary Completion: June 1, 2022
• Study Completion: May 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02