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

NCT05345873 | Unknown Phase 2

• 1 other identifier: SCTV01E-01-mRNA-THA-1
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2; Vaccine

Outcome Measures

Primary Outcomes (2)

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

  Day 28 after the study vaccination

• GMT of nAb to Delta variant on Day 28

  Day 28 after the study vaccination

Secondary Outcomes (6)

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

  Day 28 after the study vaccination

• Seroresponse rates of nAb to Omicron variant on Day 28

  Day 28 after the study vaccination

• Seroresponse rates of nAb to Delta variant on Day 28

  Day 28 after the study vaccination

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

  Day 0 to Day 7 after the study vaccination

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

  Day 0 to Day 28 after the study vaccination

Study Arms (2)

SCTV01E Group

EXPERIMENTAL

one dose of SCTV01E, intramuscular

Biological: SCTV01E

mRNA-1273

ACTIVE COMPARATOR

one dose of mRNA-1273, intramuscular

Biological: mRNA-1273

Interventions

SCTV01E BIOLOGICAL

one dose of SCTV01E on D0, intramuscular

SCTV01E Group

mRNA-1273 BIOLOGICAL

one dose of mRNA-1273 on D0, intramuscular

mRNA-1273

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participants are eligible to be included in the study only if the following conditions are met:
• Male or female aged 12-17 years old when signing ICF;
• 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;
• 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;
• The participant and/or his legal guardian 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.

You may not qualify if:

• 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;
• 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 Vaxzevria will not be excluded;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

MeSH Terms

Conditions

COVID-19

Interventions

SCTV01C vaccine; 2019-nCoV Vaccine mRNA-1273

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

mRNA Vaccines; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Recombinant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines; Antigens; Biological Factors

Central Study Contacts

Dilihumare ·Niyazi

CONTACT

+86 10 58628288-9014; dilihumare_niyazi@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 26, 2022
• Study Start: July 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: April 26, 2022

Record last verified: 2022-04