A Study to Evaluate the Efficacy and Safety of SCTV01E (a COVID-19 Vaccine) in Population Aged ≥18 Years

NCT05308576 | Active Not Recruiting Phase 3

• 1 other identifier: SCTV01E-MRCT-2
• Study Type: interventional
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the effectiveness of SCTV01E in participants aged ≥18 years.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination

  After the study vaccination, participants were contacted weekly to inquire about any signs or symptoms related to COVID-19. Participants were encouraged to report any COVID-19-related symptoms they experienced spontaneously during the study period.

  7 days after the study vaccination

Secondary Outcomes (8)

• cases of the first occurrence of all infection, asymptomatic infection, infection with multiple symptoms, moderate, severe, and death due to COVID-19, starting 7-days post-vaccination

  7 days after the study vaccination

• Cases of the first occurrence of all infection, asymptomatic infection, symptomatic infection, infection with multiple symptoms, respectively, starting 14-days post- vaccination.

  14 days after the study vaccination

• Cases of the first occurrence of symptomatic infection, infection with multiple symptoms, moderate, severe and death due to COVID-19, caused by SARS-CoV-2 variants, starting 14-days post-vaccination.

  14 days after the study vaccination

• Immunogenicity: GMT of neutralizing antibody (nAb) against SARS-CoV-2 variants or subvariants on 7, 14, 28, 90, 180 and 365 days post-vaccination

  Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365

• Immunogenicity: Seroresponse rate of nAb against SARS-CoV-2 (including its variants and subvariants) on Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365.

  Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365

Study Arms (2)

SCTV01E

EXPERIMENTAL

one dose of SCTV01E on D0

Biological: SCTV01E

Placebo

PLACEBO COMPARATOR

one dose of Placebo on D0

Biological: Placebo

Interventions

SCTV01E BIOLOGICAL

D0; intramuscular injection

SCTV01E

Placebo BIOLOGICAL

D0; intramuscular injection

Placebo

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 COVID-19 vaccine and/or received booster vaccination, and the interval between the last dose of COVID-19 vaccine previously received and screening is 6 to 24 months;
• The participant and/or his/her legal 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/her legal 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 last dose of study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

You may not qualify if:

• A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
• Presence of fever within 3 days before the study vaccination;
• 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 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 vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
• Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period;
• Those who are pregnant or breast-feeding or plan to be pregnant during the study period;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Guizhou center for disease control and prevention

Guiyang, Guizhou, China

Location

Related Publications (1)

• Yan L, Yi J, Liu D, Li J, Baidoo AAH, Xie L. Baseline Anti-SARS-CoV-2 IgG and Protection from Symptomatic Infection: Post Hoc Analysis of the SCTV01E Phase 3 Randomized Trial. Vaccines (Basel). 2025 Sep 19;13(9):984. doi: 10.3390/vaccines13090984.

  PMID: 41012186 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

SCTV01C 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

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: April 4, 2022
• Study Start: December 26, 2022
• Primary Completion: May 10, 2023
• Study Completion: April 1, 2024
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

CN (1)