A Study to Evaluate the Immunogenicity and Safety of a Recombinant Protein COVID-19 Vaccine SCTV01E-1 in Population Aged Above 18 Years
A Randomized, Double-blind Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-1 (Alpha/Beta/Delta/Omicron (BA.1/BA.4/BA.5) Variants S-Trimer COVID-19 Vaccine) in Population Aged 18 Years and Older
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
The study is a randomized, double-blind Phase II study. It will evaluate the immunogenicity and safety of SCTV01E-1. Approximately 400 participants aged 18 years and older will be enrolled in this study. 160 participants who have not been vaccinated with any COVID-19 vaccine will be enrolled in Cohort 1 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1. 240 participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccines at least three months ago will be enrolled in Cohort 2 and randomly assigned to receive SCTV01E-1 or SCTV01E in a ratio of 1:1.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 covid19
Started Oct 2022
Typical duration for phase_2 covid19
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2022
CompletedFirst Posted
Study publicly available on registry
August 31, 2022
CompletedStudy Start
First participant enrolled
October 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2023
CompletedAugust 31, 2022
August 1, 2022
2 months
August 30, 2022
August 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 42.
Day 42 after the study vaccination
Cohort 1: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 178.
Day 178 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 28.
Day 28 after the study vaccination
Cohort 2: Geometric mean titers (GMT) of neutralizing antibodies (nAb) against Omicron subvariant (BA.5) on Day 148.
Day 148 after the study vaccination
Secondary Outcomes (10)
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 42.
Day 42 after the study vaccination
Cohort 1: Seroresponse rates of nAb against Omicron subvariant (BA.5) on Day 178.
Day 178 after the study vaccination
Cohort 1: Incidence and severity of solicited AEs within 7 days after each of the study vaccination.
Day 0 to Day 7 after each of the study vaccination
Cohort 1: Incidence and severity of unsolicited AEs within 28 days after each of the study vaccination.
Day 0 to Day 28 after each of the study vaccination
Cohort 1: Incidence and severity of SAEs and AESIs within 180 days after each of the study vaccination.
During the whole study
- +5 more secondary outcomes
Study Arms (4)
Cohort 1: Group SCTV01E-1
EXPERIMENTAL3 doses of SCTV01E-1
Cohort 1: Group SCTV01E
ACTIVE COMPARATOR3 doses of SCTV01E
Cohort 2: Group SCTV01E-1
EXPERIMENTAL2 doses of SCTV01E-1
Cohort 2: Group SCTV01E
ACTIVE COMPARATOR2 doses of SCTV01E
Interventions
Day 0; intramuscular injection
Eligibility Criteria
You may qualify if:
- Male or female aged ≥18 years when signing ICF;
- For Cohort 1: Participants who have not been vaccinated with any COVID-19 vaccine; For Cohort 2: Participants who were fully vaccinated with 2 or 3 doses of inactivated COVID-19 vaccine and the interval between the last dose of previously vaccination and the 1st study vaccination is 3 to 24 months;
- Healthy participants or participants with pre-existing medical conditions that are in stable condition. The "pre-existing medical conditions" include but not limited to hypertension, diabetes, chronic cholecystitis and cholelithiasis, chronic gastritis, etc. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization as a consequence of worsening disease state for at least 3 months prior to study participation;
- The participant or his/her legal representative can sign written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that are available if they do not participate in the trial;
- The participant can read, understand, and fill in record cards by himself/herself or with help;
- Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the last dose of study vaccination.
You may not qualify if:
- Presence of fever (oral temperature ≥37.5℃) within 3 days before the 1st study vaccination;
- For Cohort 2 only: Known history of COVID-19 or asymptomatic SRAS-CoV-2 infection;
- A history of allergic reactions to any vaccines or drugs, such as allergy, urticaria, severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema;
- Immunocompromised patients suffering from immunodeficiency diseases, significant diseases, or 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 six months prior to enrollment. Whereas short-term (≤14 days) use of oral, inhaled and topical steroids are allowed;
- Those who have a history of HIV or tested positive for HIV;
- For Cohort 1, participants received any drugs or vaccines used to prevent COVID-19; for Cohort 2, participants received other drugs or vaccines used to prevent COVID-19 besides inactivated COVID-19 vaccines;
- A history of Severe Acute Respiratory Syndrome (SARS), Middle East Respiratory Syndrome (MERS), or related vaccination;
- A medical or family history of seizure, epilepsy, encephalopathy and psychosis;
- 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;
- Patients on antituberculosis therapy;
- 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 have acute illness, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis;
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
August 30, 2022
First Posted
August 31, 2022
Study Start
October 15, 2022
Primary Completion
December 15, 2022
Study Completion
December 15, 2023
Last Updated
August 31, 2022
Record last verified: 2022-08