The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults
A Randomized, Double-blind, Placebo-controlled Phase Ⅰ/Ⅱ Clinical Study to Evaluate the Safety, Tolerability and Immunogenicity of SCTV01C in Healthy Population Aged ≥18 Years Previously Unvaccinated Against COVID-19
1 other identifier
interventional
478
1 country
5
Brief Summary
SCTV01C-02-1 is a randomized, double-blind, placebo controlled Phase Ⅰ/Ⅱ clinical trial of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant bivalent trimeric S protein vaccine manufactured by Sinocelltech, Ltd. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental vaccine in healthy adults aged ≥ 18 Years previously unvaccinated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 covid19
Started Dec 2021
Longer than P75 for phase_1 covid19
5 active sites
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
November 16, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedFirst Posted
Study publicly available on registry
December 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2023
CompletedFebruary 8, 2024
August 1, 2023
1.7 years
November 16, 2021
February 6, 2024
Conditions
Outcome Measures
Primary Outcomes (5)
Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination.
Incidence and severity of adverse reactions occured from Day 0 to Day 7 after each dose of vaccination.
From Day 0 to Day 7 after each dose
Phase II: Geometric mean titers (GMT) and seroconversion rate of total IgG antibody (ELISA method) against the SARS-CoV-2 Alpha, Beta and Delta variants on Day 14 after the second dose of vaccination;
IgG GMT and seroconversion rate against the SARS-CoV-2 Alpha, Beta, Delta variants on Day 14 after the second dose of vaccination.
Day 14 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against Alpha and Beta variants of SARS-CoV-2 on Day 14 after the second dose of vaccination;
Day 14 after the second dose of vaccination
Phase II: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 14 after the second dose of vaccination;
Day 14 after the second dose of vaccination
Phase II: Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination;
Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination
Day 0 to Day 7 after each dose of vaccination
Secondary Outcomes (15)
Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants SARS-CoV-2 and T4-Foldon on Day 28 after the first dose of vaccination;
Day 28 after the first dose of vaccination
Phase I: GMT and seroconversion rate of total IgG antibody (ELISA method) against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Phase I: GMT and seroconversion rate of neutralizing antibody (Pseudovirus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;
Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination
Phase I: Number of IFN-γ positive (characterizing Th1) and IL-4 positive (characterizing Th2) T cell subpopulations 14 days and 90 days after the second dose of study vaccination;
Day 14 and Day 90 after the second dose of study vaccination
- +10 more secondary outcomes
Study Arms (12)
18~59 yrs. low dosage (20 μg) - SCTV01C VACCINE
EXPERIMENTAL20 participants in Phase I and 120 participants in Phase II at the age of 18\~59 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
18~59 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of 18\~59 years old will receive two doses of study adjuvant (SCT-VA02B ,0.5mL) on Day 0 and Day 28
18~59 yrs. low dosage (20 μg) - Saline
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of 18\~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - SCTV01C VACCINE
EXPERIMENTAL20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of low dosage (20 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
≥60 yrs. low dosage (20 μg) - Saline
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - SCTV01C VACCINE
EXPERIMENTAL20 participants in Phase I and 120 participants in Phase II at the age of 18\~59 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of 18\~59 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
18~59 yrs. high dosage (40 μg) - Saline
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of 18\~59 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - SCTV01C VACCINE
EXPERIMENTAL20 participants in Phase I and 120 participants in Phase II at the age of ≥60 years old will receive two doses of high dosage (40 μg/0.5mL) SCTV01C VACCINE on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of study adjuvant (SCT-VA02B, 0.5mL) on Day 0 and Day 28
≥60 yrs. high dosage (40 μg) - Saline
PLACEBO COMPARATOR4 participants in Phase I and 20 participants in Phase II at the age of ≥60 years old will receive two doses of saline (0.5mL) on Day 0 and Day 28
Interventions
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Saline is used as the other control in the trial
Eligibility Criteria
You may qualify if:
- Aged ≥18 years old when signing ICF;
- No other anti-SARS-COV-2 vaccines (approved for marketing or registered study) have been previously administered;
- Participants can sign written ICF and voluntarily participate in the study, and can fully understand the study procedure and the risk of participating in the study,
- Participants should have the ability to read, understand and fill the vaccination record card (VRC);
- Only for participants in Phase I : Those who are clinically judged to be healthy, the results of physical examination, vital signs and laboratory tests during the screening phase are normal;
- Only for participants in Phase II: Healthy participants or participants with stable underlying diseases;
- Fertile men and women of childbearing age voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after full vaccination; the pregnancy test results of women of childbearing age are negative on screening.
You may not qualify if:
- Presence of fever within 72 h before vaccination (axillary temperature ≥ 37.3℃), or active tuberculosis, or in the acute phase of other diseases;
- A history of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome (MERS), or other coronavirus infections or illness or relevant
- 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 or suffered from immunodeficiency diseases, important organ diseases, or immune diseases, etc.;
- Long-term use of immunosuppressive or immunomodulatory drugs for 14 or more days within 6 months prior to study enrollment, or planned use of immunosuppressive or immunomodulatory drugs within 2 years after study enrollment. The use of inhaled and topical corticosteroid is permitted;
- For Phase I participants only: Previously or currently suffering from clinically significant cardiovascular diseases (except for the hypertension that can be controlled with drugs), or clinically significant disorders related to respiratory system, liver and kidney (except for light fatty liver), gastrointestinal system (except for chronic gastritis), endocrine system, blood and lymphatic system, metabolic and skeletal systems, or malignancies (except for skin basal cell carcinoma and carcinoma in-situ of cervix), that may affect the study assessment, or cause risks during the study vaccination, or interfere with the data interpretation as determined by the investigator; For Phase II participants only: 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 (except for skin basal cell carcinoma and carcinoma in-situ of cervix);
- 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 intervention investigational drugs within 1 month before the vaccination (Except for the participants in the saline control group participating in the clinical study of COVID-19 vaccine);
- Participants vaccinated with influenza vaccine within 14 days, or with other type of vaccines within 28 days before the vaccination;
- Those who donated blood or had blood loss (≥450 mL) within 3 months before the first dose vaccination or plan to donate blood during the study period;
- Those who are pregnant or breast-feeding;
- Those who plan to donate ovum or sperms during the study period;
- Those who cannot follow the study procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, 100176, China
PetroChina Central Hospital
Langfang, Hebei, 050011, China
Hunan Provincial Center for Disease Control And Prevention
Changsha, Hunan, 410005, China
Related Publications (2)
Wang G, Zhao K, Zhao X, Cui Y, He P, Zhang T, Wang Y, Shi R, Li Y, Wang Q, Ren Y, Chen Z, Zhao X, Xie Z, Liang Y, Tian Q, Pan J, Zhang C, Han Y, Dai Y, Ni S, Zhang Y, Yang X, Fu Y, Liu D, Li J, Zhang M, Hu Z, Xie L. Sustained immunogenicity of bivalent protein COVID-19 vaccine SCTV01C against antigen matched and mismatched variants. Expert Rev Vaccines. 2025 Dec;24(1):128-137. doi: 10.1080/14760584.2025.2456231. Epub 2025 Jan 27.
PMID: 39834144DERIVEDWang G, Zhao K, Han J, Hu Z, Zhang T, Wang Y, Shi R, Li Y, Song Q, Du H, He P, Xu S, Yang X, Fu Y, Cui Y, Xie L. Safety and immunogenicity of a bivalent SARS-CoV-2 recombinant protein vaccine, SCTV01C in unvaccinated adults: A randomized, double-blinded, placebo-controlled, phase I clinical trial. J Infect. 2023 Feb;86(2):154-225. doi: 10.1016/j.jinf.2022.11.008. Epub 2022 Nov 17. No abstract available.
PMID: 36403700DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yimin Cui, M.D.
Peking University First Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 16, 2021
First Posted
December 8, 2021
Study Start
December 1, 2021
Primary Completion
August 4, 2023
Study Completion
August 4, 2023
Last Updated
February 8, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share