The Safety and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Vaccinated With mRNA COVID-19 Vaccine.

NCT05043311 | Unknown Phase 1 DMC

• 1 other identifier: SCTV01C-01-2
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to evaluate the safety, tolerability and immunogenicity of SCTV01C in healthy population aged ≥18 years previously vaccinated with mRNA COVID-19 vaccine.

Conditions

COVID-19; SARS-CoV-2 Infection

Keywords

COVID-19; SARS-CoV-2; Vaccine

Outcome Measures

Primary Outcomes (4)

• Incidence and severity of adverse reactions in phase 1

  Day 0 to Day 7 after the study vaccination

• GMT and GMI of specific IgG total antibodies against Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1) and Delta (B.1.617.2) variants of SARS-CoV-2 in phase 2

  Day 14 after the study vaccination

• GMT and GMI of neutralizing antibodies titers in phase 2

  Day 14 after the study vaccination

• Incidence and severity of solicited AEs in phase 2

  Day 0 to Day 7 after the study vaccination

Secondary Outcomes (10)

• Incidence and severity of solicited adverse events in phase 1

  Day 0 to Day 7 after the study vaccination

• Incidence and severity of all unsolicited adverse events in phase 1

  Day 0 to Day 28 after the study vaccination

• Incidence and severity of laboratory abnormalities related adverse events in phase 1

  Day 3 after the study vaccination

• Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) in phase 1

  Within 180 days after the study vaccination

• GMT and GMI of specific IgG total antibodies against Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1) and Delta (B 1.617.2) variants of SARS-CoV-2 in phase 1

  Day 14 after the study vaccination

Study Arms (6)

Experimental: 20 µg dose, 18-59 years of age (phase 1/2)

EXPERIMENTAL

Biological: SCTV01C

Experimental: 20 µg dose, ≥60 years of age (phase 1/2)

EXPERIMENTAL

Biological: SCTV01C

Experimental: 40 µg dose, 18-59 years of age (phase 1/2)

EXPERIMENTAL

Biological: SCTV01C

Experimental: 40 µg dose, ≥60 years of age (phase 1/2)

EXPERIMENTAL

Biological: SCTV01C

Placebo Comparator: Placebo, 18-59 years of age (phase 1/2)

PLACEBO COMPARATOR

Other: Placebo

Placebo Comparator: Placebo, ≥60 years of age (phase 1/2)

PLACEBO COMPARATOR

Other: Placebo

Interventions

SCTV01C BIOLOGICAL

intramuscular injection

Experimental: 20 µg dose, 18-59 years of age (phase 1/2); Experimental: 20 µg dose, ≥60 years of age (phase 1/2); Experimental: 40 µg dose, 18-59 years of age (phase 1/2); Experimental: 40 µg dose, ≥60 years of age (phase 1/2)

Placebo OTHER

intramuscular injetion

Placebo Comparator: Placebo, 18-59 years of age (phase 1/2); Placebo Comparator: Placebo, ≥60 years of age (phase 1/2)

Eligibility Criteria

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

You may qualify if:

• Phase I:
• 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 that were fully vaccinated with mRNA anti-SARS-CoV-2 vaccine, and the last dose is ≥6 months away from the vaccination of this study.
• Participants that 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;
• Ability to read, understand, and fill in record cards;
• Those who are clinically judged to be healthy, the results of physical examination, vital signs and laboratory tests during the screening period are normal, or although beyond the normal reference range, they are judged by investigators to be of no clinical significance;
• Fertile men and women of childbearing age 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 age are negative on screening.
• Phase II:
• 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 that were fully vaccinated with mRNA anti-SARS-CoV-2 vaccine, and the last dose is ≥6 months away from the vaccination of this study.
• Participants that 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;
• 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;

You may not qualify if:

• Phase I:
• A participant who conforms to any of the following criteria should not be enrolled in the study:
• Previous diagnosis of COVID-19;
• High-risk populations (such as medical workers, close contacts of patients with COVID-19 infection, etc.) who are more likely to be infected with SARS-Cov-2;
• Presence of fever within 3 days before the study vaccination;
• 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 first six months prior to enrollment, or plan to use immunosuppressant therapy or immunomodulatory drugs within two years after enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed.
• Patients on antituberculosis therapy;
• Previously or currently suffering from clinically significant cardiovascular diseases, or clinically significant disorders related to respiratory system, liver and kidney, gastrointestinal system, endocrine system, blood and lymphatic system, metabolic and skeletal systems, or malignancies, that may affect the study assessment, or cause risks during the study vaccination, or interfere with the data interpretation as determined by the investigator;
• 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;

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Al Kuwait Hospital (Al Baraha Hospital)

Dubai, United Arab Emirates

RECRUITING

Related Publications (1)

• Hannawi S, Saifeldin L, Abuquta A, Alamadi A, Mahmoud SA, Hassan A, Liu D, Yan L, Xie L. Safety and immunogenicity of a bivalent SARS-CoV-2 protein booster vaccine, SCTV01C, in adults previously vaccinated with mRNA vaccine: a randomized, double-blind, placebo-controlled phase 1/2 clinical trial. EBioMedicine. 2023 Jan;87:104386. doi: 10.1016/j.ebiom.2022.104386. Epub 2022 Dec 5.

  PMID: 36470077 DERIVED

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 Officials

• Yang Wang, Ph.D.

  Sinocelltech Ltd.

  STUDY DIRECTOR

Central Study Contacts

Bo Zhong, M.D.

CONTACT

+86 13810917207; bo_zhong@sinocelltech.com

Yu Sun, M.D.

CONTACT

+86 13816901291; yu_sun@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a randomized, double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety, tolerability and immunogenicity of SCTV01C (A Bivalent Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Variants) in healthy population aged ≥18 years previously vaccinated with mRNA vaccine against COVID-19. In the study, participants receive 20 µg dose or placebo, 40 µg dose or placebo.

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 14, 2021
• Study Start: December 22, 2021
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)