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COVID-19Phase 3NCT05308576

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

A Phase 3 study testing SCTV01E in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS-CoV-2 Infection
What is being tested?
SCTV01E
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10,000 participants
Where
1 siteChina
Study dates
26 Dec 2022to Apr 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Those who plan to donate ovum or sperms during the study period;
  • Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
  • 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;
  • Those who are tested positive for HIV in terms of serology.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Guizhou center for disease control and prevention

    Guiyang, Guizhou

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
SCTV01E, Placebo
Keywords
COVID-19, SARS-CoV-2 infection, Vaccine
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SCTV01EBiological

    D0; intramuscular injection

  • PlaceboBiological

    D0; intramuscular injection

Study groups in NCT05308576
Study groupRoleWhat they receive
SCTV01EExperimentalone dose of SCTV01E on D0
Receives: Biological: SCTV01E
PlaceboPlacebo comparatorone dose of Placebo on D0
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 7 days after the study vaccination

Secondary outcomes (8)

  1. 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

    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.

    Measured: 7 days after the study vaccination

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

    Measured: 14 days after the study vaccination

  3. 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.

    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.

    Measured: 14 days after the study vaccination

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

    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).

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

  5. 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.

    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

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

  6. Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7.

    Both active monitoring and spontaneous reporting were used. Solicited AEs within 7 days after the study vaccination were collected through vaccination record cards (VRCs).

    Measured: Day 0 to Day 7 after the study vaccination.

  7. Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.

    Both active monitoring and spontaneous reporting were used. Unsolicited AEs within 28 days after the study vaccination were collected through vaccination record cards (VRCs).

    Measured: Day 0 to Day 28 after the study vaccination.

  8. Safety: Incidence and severity of SAEs and AESIs from D0 to D365.

    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.

    Measured: Day 0 to Day 365 after the study vaccination.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Apr 2022
  2. Study start26 Dec 2022
  3. Primary completion10 May 2023
  4. Study completionApr 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05308576
Sponsor's protocol ID
SCTV01E-MRCT-2
Status last verified
Apr 2024
First submitted
11 Feb 2022
Last updated
15 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41012186

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCTV01E in people with COVID-19 and SARS-CoV-2 Infection, run by Sinocelltech Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05308576, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.

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