A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine as a Booster Dose in Population Aged 12-17 Years

NCT ID: NCT05345873

Last Updated: 2022-04-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-04-01

Brief 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 mRNA-1273 (the mRNA COVID-19 vaccine from Moderna) in population aged 12-17 years old and previously vaccinated with 2 doses of mRNA COVID-19 vaccine.

Detailed Description

Approximately 300 participants aged 12-17 years old and previously vaccinated with 2 doses of mRNA COVID-19 vaccine (Comirnaty from Pfizer or mRNA-1273 from Moderna, participants previously vaccinated with mRNA1273 are more preferred) will be enrolled in this study and be randomly assigned to SCTV01E Group and mRNA-1273 Group in a ratio of 1:1.

Conditions

COVID-19; SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

SCTV01E Group

one dose of SCTV01E, intramuscular

Group Type: EXPERIMENTAL

SCTV01E

Intervention Type: BIOLOGICAL

one dose of SCTV01E on D0, intramuscular

mRNA-1273

one dose of mRNA-1273, intramuscular

Group Type: ACTIVE_COMPARATOR

mRNA-1273

Intervention Type: BIOLOGICAL

one dose of mRNA-1273 on D0, intramuscular

Interventions

SCTV01E

one dose of SCTV01E on D0, intramuscular

Intervention Type: BIOLOGICAL

mRNA-1273

one dose of mRNA-1273 on D0, intramuscular

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Participants are eligible to be included in the study only if the following conditions are met:

1. Male or female aged 12-17 years old when signing ICF;

2. Participants who were fully vaccinated with 2 doses of mRNA COVID-19 vaccine (mRNA-1273 from Moderna or Comirnaty from Pfizer, participants previously vaccinated with mRNA1273 are more preferred) and the interval between the last dose and this study vaccination is 3 to 12 months;

3. The participant and/or his legal guardian 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 has 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 study vaccination; the pregnancy test results of women of childbearing potential are negative on screening.

Exclusion Criteria

• A participant who conforms to any of the following criteria should be excluded from the study:

1. Presence of fever within 3 days before the study vaccination;

2. A positive result of nucleic acid test for SARS-CoV-2 during the screening period or previously diagnosed with COVID-19;

3. 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;

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 (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;

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 stage of illness, 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, but participants previously received Vaxzevria will not be excluded;

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sinocelltech Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Dilihumare ·Niyazi

Role: CONTACT

dilihumare_niyazi@sinocelltech.com

+86 10 58628288-9014

Other Identifiers

SCTV01E-01-mRNA-THA-1

Identifier Type: -

Identifier Source: org_study_id