The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults
NCT ID: NCT05148091
Last Updated: 2024-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
478 participants
INTERVENTIONAL
2021-12-01
2023-08-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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18~59 yrs. low dosage (20 μg) - SCTV01C VACCINE
20 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
SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
18~59 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )
4 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
Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
18~59 yrs. low dosage (20 μg) - Saline
4 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
Saline
Saline is used as the other control in the trial
≥60 yrs. low dosage (20 μg) - SCTV01C VACCINE
20 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
SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
≥60 yrs. low dosage (20 μg) - Adjuvant (SCT-VA02B )
4 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
Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
≥60 yrs. low dosage (20 μg) - Saline
4 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
Saline
Saline is used as the other control in the trial
18~59 yrs. high dosage (40 μg) - SCTV01C VACCINE
20 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
SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
18~59 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )
4 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
Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
18~59 yrs. high dosage (40 μg) - Saline
4 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
Saline
Saline is used as the other control in the trial
≥60 yrs. high dosage (40 μg) - SCTV01C VACCINE
20 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
SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
≥60 yrs. high dosage (40 μg) - Adjuvant (SCT-VA02B )
4 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
Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
≥60 yrs. high dosage (40 μg) - Saline
4 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
Saline
Saline is used as the other control in the trial
Interventions
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SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Saline
Saline is used as the other control in the trial
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* Those unsuitable for participating in the clinical study as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants;
* For Phase I participants only: those who are tested positive for hepatitis B virus (HBV), hepatitis C virus (HCV), syphilis or HIV in terms of etiology or serology; For Phase II participants only: those who are tested positive for HIV in terms of etiology or serology.
18 Years
ALL
Yes
Sponsors
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Sinocelltech Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yimin Cui, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Anhui Provincial Hospital
Hefei, Anhui, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital, CMU
Beijing, Beijing Municipality, China
PetroChina Central Hospital
Langfang, Hebei, China
Hunan Provincial Center for Disease Control And Prevention
Changsha, Hunan, China
Countries
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References
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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.
Wang 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.
Other Identifiers
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SCTV01C-02-1
Identifier Type: -
Identifier Source: org_study_id
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