CClinicalTrials.gg
Status unknownNCT05239806Updated Apr 11, 2022

A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E in Population Aged ≥12 Years Previously Fully Vaccinated With Inactivated COVID-19 Vaccine

A Phase 2 interventional study of SCTV01C and SCTV01E in COVID-19 and SARS-CoV-2 Infection, sponsored by Sinocelltech Ltd.. Status unknown. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-11.

Sponsored by Sinocelltech Ltd. · Phase 2, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Feb 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
12 Years and older
Sex
All
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Study summary

The objective of study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E as booster compared with Sinopharm inactivated COVID-19 vaccine as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations.

Read the detailed description

The study is a randomized, double-blind, and approved vaccine-controlled Phase II booster study. It will evaluate the immunogenicity and safety of one dose of SCTV01C or SCTV01E as booster compared with one dose of Sinopharm inactivated COVID-19 vaccine or one dose of Commirnaty as booster. The study will also evaluate the immunogenicity and safety of 2-dose vaccinations (1-dose of SCTV01C and 1-dose of SCTV01E, or 2-dose of SCTV01E, or 1-dose of Sinopharm inactivated COVID-19 vaccine and 1-dose of SCTV01E, 1-dose of Comirnaty and 1-dose of SCTV01E).

02

Conditions studied

  • COVID-19
  • SARS-CoV-2 Infection

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Keywords

  • COVID-19
  • SARS-CoV-2 infection
  • Vaccine
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 400 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Sinocelltech Ltd. is the lead sponsor of 78 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Male or female aged ≥12 years old when signing ICF;
  2. Participants who were fully vaccinated with inactivated COVID-19 vaccine (Sinopharm inactivated COVID-19 vaccine), and the interval between the last dose and this study vaccination is ≥3 months and ≤12 months;
  3. The participant and/or his legal guardian 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;
  4. The participant and/or his legal guardian and/or his entrusted person 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 1st study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion criteria

Exclusion Criteria:

  1. Previously diagnosed with COVID-19;
  2. Presence of fever within 3 days before the study vaccination;
  3. 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;
  4. A history of allergic reactions to any vaccine or drug, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
  5. A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
  6. 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.;
  7. 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;
  8. Patients on antituberculosis therapy;
  9. 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix), such as severe heart failure, severe pulmonary heart disease, unstable angina, liver failure, or uremia;
  10. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders;
  11. Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study;
  12. Participants who received other investigational drugs within 1 month before the study vaccination;
  13. 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;
  14. Participants received other drugs or vaccines used to prevent COVID-19 (exception for Sinopharm inactivated COVID-19 vaccine) ;
  15. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;
  16. 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;
  17. Those who are pregnant or breast-feeding or plan to be pregnant during the study period;
  18. Those who plan to donate ovum or sperms during the study period;
  19. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
  20. 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;
  21. Those who are tested positive for HIV in terms of serology.
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    SCTV01C

    Participants will receive one dose of SCTV01C on Day 0 and one dose of SCTV01E on Day 180.

    Biological: SCTV01C · Biological: SCTV01E

  • Experimental
    SCTV01E

    Participants will receive one dose of SCTV01E on Day 0 and one dose of SCTV01E on Day 180.

    Biological: SCTV01E

  • Active comparator
    Sinopharm inactivated COVID-19 vaccine

    Participants will receive one dose of Sinopharm inactivated COVID-19 vaccine on Day 0 and one dose of SCTV01E on Day 180.

    Biological: Sinopharm inactivated COVID-19 vaccine · Biological: SCTV01E

  • Active comparator
    Comirnaty

    Participants will receive one dose of Comirnaty on Day 0 and one dose of SCTV01E on Day 180.

    Biological: Comirnaty · Biological: SCTV01E

Interventions

  • BiologicalSCTV01C

    Day 0; intramuscular injection

  • BiologicalSCTV01E

    Day 0; intramuscular injection

  • BiologicalSinopharm inactivated COVID-19 vaccine

    Day 0; intramuscular injection

  • BiologicalComirnaty

    Day 0; intramuscular injection

  • BiologicalSCTV01E

    Day 180; intramuscular injection

06

What researchers measure

Primary outcomes

  1. GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 28.

    Time frame: Day 28 after the study vaccination

  2. GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 28.

    Time frame: Day 28 after the study vaccination

  3. GMT of neutralizing antibodies against Delta (B.1.617.2) variant on Day 208.

    Time frame: Day 208 after the study vaccination

  4. GMT of neutralizing antibodies against Omicron (B.1.1.529) variant on Day 208.

    Time frame: Day 208 after the study vaccination

Secondary outcomes

  1. Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subsets on Day 28 and Day 208.

    Time frame: Day 28 and D208 after the study vaccination

  2. Seroresponse rates of neutralizing antibodiesto Delta variant on Day 28.

    Time frame: Day 28 after the study vaccination

  3. Seroresponse rates of neutralizing antibodies to Omicron variant rates on Day 28.

    Time frame: Day 28 after the study vaccination

  4. Seroresponse rates of neutralizing antibodies to Delta variant on Day 208.

    Time frame: Day 208 after the study vaccination

  5. Seroresponse rates of neutralizing antibodies to Omicron variant on Day 208.

    Time frame: Day 208 after the study vaccination

  6. Incidence and severity of solicited AEs of SCTV01C from Day 0 to Day 7 and Day 180 to Day 187.

    Time frame: Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination

  7. Incidence and severity of all unsolicited AEs of SCTV01C from Day 0 to Day 28 and Day 180 to Day 208.

    Time frame: Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination

  8. Incidence and severity of SAEs and AESIs of SCTV01C within 365 days.

    Time frame: Day 0 to Day 365 after the 1st study vaccination

  9. Incidence and severity of solicited AEs of SCTV01E from Day 0 to Day 7 and Day 180 to Day 187.

    Time frame: Day 0 to Day 7 after the 1st study vaccination and Day 180 to Day 187 after the 2nd study vaccination

  10. Incidence and severity of all unsolicited AEs of SCTV01E from Day 0 to Day 28 and Day 180 to Day 208.

    Time frame: Day 0 to Day 28 after the 1st study vaccination and Day 180 to Day 208 after the 2nd study vaccination

  11. Incidence and severity of SAEs and AESIs of SCTV01E within 365 days.

    Time frame: Day 0 to Day 365 after the 1st study vaccination

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05239806
Lead sponsor
Sinocelltech Ltd.
Responsible party
Sponsor
First posted
Feb 15, 2022
Start date
Apr 1, 2022 (estimated)
Primary completion
Aug 1, 2022 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Apr 11, 2022

Study contacts

Min Ke
Contact
min_ke@sinocelltech.com
+86 18501160269
Yongpan Fu
Contact
yongpan_fu@sinocelltech.com
+86 18612320378

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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