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

April 10, 2024 updated by: Sinocelltech Ltd.

A Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of SCTV01E (Alpha/Beta/Delta/Omicron Variants S-Trimer COVID-19 Vaccine) in Population Aged ≥18 Years

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a randomized, double-blind, placebo-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously received primary series or booster dose of COVID-19 vaccines.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China
        • Guizhou Center for Disease Control and Prevention

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Male or female aged ≥18 years old when signing ICF;
  2. 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;
  3. 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;
  4. The participant and/or his/her legal 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 last dose of study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion Criteria:

  1. A positive result of nucleic acid test or rapid antigen test for SARS-CoV-2 during the screening period;
  2. Presence of fever within 3 days before the study vaccination;
  3. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
  4. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
  5. 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.;
  6. 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;
  7. Patients on antituberculosis therapy;
  8. 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;
  9. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
  10. Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
  11. Participants who received other investigational drugs within 1 month before the study vaccination;
  12. 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;
  13. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
  14. 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;
  15. Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
  16. Those who plan to donate ovum or sperms during the study period;
  17. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
  18. Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants;
  19. Those who are tested positive for HIV in terms of serology.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SCTV01E
one dose of SCTV01E on D0
Biological: SCTV01E
D0; intramuscular injection
Placebo Comparator: Placebo
one dose of Placebo on D0
Biological: Placebo
D0; intramuscular injection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination
Time Frame: 7 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: 7 days 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
Cases of the first occurrence of all infection, asymptomatic infection, symptomatic infection, infection with multiple symptoms, respectively, starting 14-days post- vaccination.
Time Frame: 14 days 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.
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.
Time Frame: 14 days 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.
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
Time Frame: Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365
Blood samples were collected from participants in the immunogenicity subgroup on 0 (pre-injection), 14, and 28 days post-vaccination. Additional blood samples were collected from 200 participants in the immunogenicity subgroup on 7, 90, 180 and 365 days post-vaccination for geometric mean titers (GMTs) of live virus neutralizing antibodies against Omicron BA.5 variant using 50% plaque reduction neutralization test (PRNT50).
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.
Time Frame: Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365
the sereresponse rates (SRRs) of nAb (change from <lower limit of quantification (LLOQ) to ≥4 ×LLOQ, or at least a fourfold rise if baseline ≥LLOQ) compared with the pre-injection baseline (95%CI) against SARS-CoV-2 variants or subvariants
Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365
Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7.
Time Frame: Day 0 to Day 7 after the study vaccination.
Both active monitoring and spontaneous reporting were used. Solicited AEs within 7 days after the study vaccination were collected through vaccination record cards (VRCs).
Day 0 to Day 7 after the study vaccination.
Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
Time Frame: Day 0 to Day 28 after the study vaccination.
Both active monitoring and spontaneous reporting were used. Unsolicited AEs within 28 days after the study vaccination were collected through vaccination record cards (VRCs).
Day 0 to Day 28 after the study vaccination.
Safety: Incidence and severity of SAEs and AESIs from D0 to D365.
Time Frame: Day 0 to Day 365 after the study vaccination.
Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected by investigators via phone calls, short messages, e-mails, visits on-site, or other contact methods for up to 365 days.
Day 0 to Day 365 after the study vaccination.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sinocelltech Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 10, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SCTV01E-MRCT-2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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