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SARS-CoV-2 InfectionPhase 2NCT05329051

A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine in Population Aged ≥18 Years

A Phase 2 study testing SCTV01E and Comirnaty in people with SARS-CoV-2 Infection and COVID-19, run by Sinocelltech Ltd..

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 The sponsor has not verified this record for over two years, so it may be out of date.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 study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with Comirnaty. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2 Infection, COVID-19
What is being tested?
SCTV01E and Comirnaty
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
1 Jul 2022to 1 Mar 2023
Phase
Phase 2
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

  • Participants are eligible to be included in the study only if the following conditions are met:
  • Male or female aged ≥18 years old when signing ICF;
  • Participants who were fully vaccinated with 2 or 3 doses of mRNA COVID-19 vaccine (Comirnaty). The interval between the last dose and this study vaccination is 4 to 12 months;
  • The participant 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 entrusted person has 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 study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Who cannot join

  • A participant who conforms to any of the following criteria should be excluded from the study:
  • Presence of fever within 3 days before the study vaccination;
  • A positive result of nucleic acid test for SARS-CoV-2 during the screening period or previously diagnosed with COVID-19;
  • A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other disease with 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;
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  • 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 stage of illness, 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 will not be excluded;
  • 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

No sites are listed yet.

Dilihumare ·Niyazi contact

+86 10 58628288-9014

dilihumare_niyazi@sinocelltech.com

About this study

Official title: A Randomized, Double-blind, Positive-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E (A COVID-19 Alpha/Beta/Delta/Omicron Variants S-Trimer Vaccine) in Population Aged ≥18 Years and Previously Fully Vaccinated With mRNA COVID-19

The study is a randomized, double-blind, positive-controlled Phase II booster study. It will evaluate the immunogenicity and safety of SCTV01E compared with Comirnaty.

Read the detailed description

Approximately 400 participants aged ≥18 years old and previously vaccinated with 2 or 3 doses of Comirnaty will be enrolled in this study. They will be randomly assigned to SCTV01E Group and Comirnaty Group in a ratio of 1:1.

Being tested
SCTV01E, Comirnaty
Keywords
SARS-CoV-2, COVID-19, 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

    intramuscular injection

  • ComirnatyBiological

    intramuscular injection

Study groups in NCT05329051
Study groupRoleWhat they receive
SCTV01E GroupExperimentalParticipants will receive one dose of SCTV01E on Day 0
Receives: Biological: SCTV01E
Comirnaty GroupActive comparatorParticipants will receive one dose of Comirnaty on Day 0
Receives: Biological: Comirnaty

What is being measured

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

  1. Geometric mean titers (GMT) of neutralizing antibodies (nAb) to Omicron variant on Day 28

    Measured: day 28 sfter the study vaccination

  2. GMT of nAb to variant Delta on Day 28

    Measured: day 28 sfter the study vaccination

Secondary outcomes (10)

  1. GMT of nAb to Alpha variant on Day 28

    Measured: day 28 sfter the study vaccination

  2. GMT of nAb to Beta variant on Day 28

    Measured: day 28 sfter the study vaccination

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

    Measured: day 28 sfter the study vaccination

  4. Seroresponse rates of nAb to Omicron variant on D28

    Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline

    Measured: day 28 after the study vaccination

  5. Seroresponse rates of nAb to Delta variant on D28

    Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline

    Measured: day 28 after the study vaccination

  6. Seroresponse rates of nAb to Alpha variant on D28

    Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline

    Measured: day 28 after the study vaccination

  7. Seroresponse rates of nAb to Beta variant on D28

    Seroresponse is defined as a change from below the low limit of quantitation [LLOQ] to equal to or above LLOQ, or a ≥4-fold rise if baseline is equal to or above LLOQ in nAb from baseline

    Measured: day 28 after the study vaccination

  8. Incidence and severity of solicited AEs from Day 0 to Day 7 after the study vaccination

    Measured: day 0 to day 7 after the study vaccination

  9. Incidence and severity of unsolicited AEs from Day 0 to Day 28 after the study vaccination

    Measured: day 0 to day 28 after the study vaccination

  10. Incidence and severity of SAEs and AESIs within 180 days after study vaccination

    Measured: day 0 to day 180 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 posted14 Apr 2022
  2. Study start1 Jul 2022 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Mar 2023 (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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05329051
Sponsor's protocol ID
SCTV01E-01-mRNA-BRA-1
Status last verified
Apr 2022
First submitted
11 Apr 2022
Last updated
14 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SCTV01E and Comirnaty in people with SARS-CoV-2 Infection and COVID-19, run by Sinocelltech Ltd..

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 7 inclusion and 22 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 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact Dilihumare ·Niyazi (+86 10 58628288-9014, dilihumare_niyazi@sinocelltech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric mean titers (GMT) of neutralizing antibodies (nAb) to Omicron variant on Day 28 (time frame: day 28 sfter the study vaccination). The study lists 2 primary outcomes in all. 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 NCT05329051.

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 14 Apr 2022.

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