A Study to Evaluate the Immunogenicity and Safety of SCTV01C and SCTV01E (Two Recombinant Protein COVID-19 Vaccines) in Population Aged ≥12 Years

NCT05308602 | Withdrawn Phase 2

• 1 other identifier: SCTV01C/E-02-In-Laos-1
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of the study is to evaluate the immunogenicity and safety of SCTV01C or SCTV01E, comparing the immunogenicity data against Beta (B.1.351), Delta (B.1.617.2), Omicron (B.1.1.529) and other variants with Sinopharm inactivated COVID-19 vaccine or mRNA vaccine.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2 infection; Vaccine

Outcome Measures

Primary Outcomes (7)

• Stage 1: Geometric mean titers (GMT) of neutralizing antibody against Beta (B.1.351) variant on Day 56 (28 days after the 2nd dose of vaccination);

  Day 56 after the study vaccination

• Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 56 (28 days after the 2nd dose of vaccination);

  Day 56 after the study vaccination

• Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 56 (28 days after the 2nd dose of vaccination);

  Day 56 after the study vaccination

• Stage 2: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 208 (28 days after the 3rd dose of vaccination);

  Day 208 after the study vaccination

• Stage 2: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 208 (28 days after the 3rd dose of vaccination);

  Day 208 after the study vaccination

• Stage 2: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 208 (28 days after the 3rd dose of vaccination);

  Day 208 after the study vaccination

• Incidence and severity of solicited AEs within 7 days after each dose of vaccine (Day 0 to Day 7, Day 28 to Day 35, and Day 180 to Day 187).

  7 days after each study vaccination

Secondary Outcomes (12)

• Stage 1: GMT of neutralizing antibody against Beta (B.1.351) variant on Day 180 (before the injection of the 3rd dose of vaccination);

  Day 180 after the study vaccination

• Stage 1: GMT of neutralizing antibody against Delta (B.1.617.2) variant on Day 180 (before the injection of the 3rd dose of vaccination);

  Day 180 after the study vaccination

• Stage 1: GMT of neutralizing antibody against Omicron (B.1.1.529) variant on Day 180 (before the injection of the 3rd dose of vaccination);

  Day 180 after the study vaccination

• Stage 1: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations on Day 0, Day14, Day 28 and Day 42;

  Day 0, Day 14, Day 28 and Day 42 after the study vaccination

• Stage 1: Seroresponse rates of neutralizing antibodies to Beta [B.1.351], Delta [B.1.617.2] and Omicron [B.1.1.529] variants on Day 56;

  Day 56 after the study vaccination

Study Arms (4)

SCTV01C

EXPERIMENTAL

Biological: SCTV01C

SCTV01E

EXPERIMENTAL

Biological: SCTV01E

mRNA vaccine manufactured by Pfizer or Moderna

ACTIVE COMPARATOR

Biological: mRNA vaccine manufactured by Pfizer or Moderna

Sinopharm inactivated COVID-19 vaccine

ACTIVE COMPARATOR

Biological: Sinopharm inactivated COVID-19 vaccine

Interventions

SCTV01C BIOLOGICAL

Day 0; intramuscular injection

SCTV01C

SCTV01E BIOLOGICAL

Day 0; intramuscular injection

SCTV01E

mRNA vaccine manufactured by Pfizer or Moderna BIOLOGICAL

Day 0; intramuscular injection

mRNA vaccine manufactured by Pfizer or Moderna

Sinopharm inactivated COVID-19 vaccine BIOLOGICAL

Day 0; intramuscular injection

Sinopharm inactivated COVID-19 vaccine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥12 years old when signing ICF;
• Participants who were neither vaccinated with any COVID-19 vaccine (including COVID-19 vaccine or vaccine adjuvant in clinical trial) nor diagnosed with COVID-19;
• Participants or his/her legal guardian (or entrusted person) can sign written ICF and voluntarily participate in the trial, 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;
• Participant him/herself or with the assistance of his/her family member is capable of finishing the 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 age 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 age are negative on screening.

You may not qualify if:

• Presence of fever within 3 days before the study vaccination;
• A positive result of IgG antibody against the SARS-CoV-2 virus during the screen period;
• A history of infection or disease related to severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or corresponding 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 1st 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 (exception 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;
• 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, 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 received other drugs used for prevention of COVID-19;
• Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

MeSH Terms

Conditions

COVID-19

Interventions

SCTV01C vaccine

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

Study Design

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

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: April 4, 2022
• Study Start: April 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: February 9, 2024

Record last verified: 2022-03