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The Safety, Tolerability and Immunogenicity of COVID-19 Vaccine (SCTV01C) in Healthy, Unvaccinated Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05148091
Recruitment Status : Recruiting
First Posted : December 8, 2021
Last Update Posted : January 3, 2022
Sponsor:
Information provided by (Responsible Party):
Sinocelltech Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: SCTV01C Other: Adjuvant Other: Saline Phase 1 Phase 2

Detailed Description:
This study is a randomized, double-blind, multi-center, placebo-controlled phase Ⅰ/Ⅱ clinical trial in adults aged ≥ 18 years previously unvaccinated. The purpose of this study is to evaluate the safety , tolerability and immunogenicity of the experimental SARS-CoV-2 protein vaccine (SCTV01C). The experimental vaccine and adjuvant (one placebo) were both manufactured by Sinocelltech, Ltd., while the saline (the other placebo) was commercially purchased. A total of 752 participants will be enrolled, with 112 at phase Ⅰ, and 640 at phase Ⅱ. There will be two dosage levels (20μg and 40μg), and two age groups (18~59 years old and ≥ 60 years old ) at both Phase Ⅰ and Phase Ⅱ. All of participants will be assigned to receive two doses of experimental vaccine(20μg or 40μg) or placebo (Adjuvant or Saline) on the schedule of Day 0 and Day 28.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 752 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : December 1, 2021
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Biological: SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
Placebo Comparator: 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
 Other: Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Other Name: SCT-VA02B
Placebo Comparator: 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
 Other: Saline
Saline is used as the other control in the trial
Experimental: ≥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
 Biological: SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
Placebo Comparator: ≥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
 Other: Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Other Name: SCT-VA02B
Placebo Comparator: ≥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
 Other: Saline
Saline is used as the other control in the trial
Experimental: 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
 Biological: SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
Placebo Comparator: 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
 Other: Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Other Name: SCT-VA02B
Placebo Comparator: 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
 Other: Saline
Saline is used as the other control in the trial
Experimental: ≥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
 Biological: SCTV01C
A Recombinant Trimeric S Protein Vaccine against SARS-CoV-2 Alpha and Beta Variants
Placebo Comparator: ≥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
 Other: Adjuvant
SCT-VA02B is the adjuvant of SCTV01C VACCINE applied as one of the control in the trial
Other Name: SCT-VA02B
Placebo Comparator: ≥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
 Other: Saline
Saline is used as the other control in the trial


Outcome Measures
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Primary Outcome Measures :
  1. Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination. [ Time Frame: From Day 0 to Day 7 after each dose ]
    Incidence and severity of adverse reactions occured from Day 0 to Day 7 after each dose of vaccination.

  2. 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; [ Time Frame: 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.

  3. 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; [ Time Frame: 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;

  4. 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; [ Time Frame: 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;

  5. Phase II: Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination; [ Time Frame: 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


Secondary Outcome Measures :
  1. 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; [ Time Frame: Day 28 after the first dose of vaccination ]
    GMT and seroconversion rate of total IgG antibody against the Alpha, Beta, Delta variants of SARS-CoV-2 and T4-Foldon on Day 28 after the first dose of vaccination

  2. 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; [ Time Frame: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination; ]
    GMT and seroconversion rate of total IgG antibody 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

  3. 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; [ Time Frame: Day 14, Day 28, Day 90, Day 180 and Day 365 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 of SARS-CoV-2on Day 14, Day28, Day 90, Day 180 and Day 365 after the second dose of vaccination;

  4. 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; [ Time Frame: Day 14, Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination ]
    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;

  5. 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; [ Time Frame: Day 14 and Day 90 after the second dose of study vaccination ]
    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;

  6. Phase I: Incidence and severity of solicited adverse events (AEs) from Day 0 to Day 7 days after each dose of vaccination; [ Time Frame: Day 0 to Day 7 days after each dose of vaccination ]
    Incidence and severity of solicited adverse events (AEs) from Day 0 to Day 7 days after each dose of vaccination.;

  7. Phase I: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination; [ Time Frame: Day 0 to Day 28 after each dose of vaccination ]
    Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;

  8. Phase I: Incidence and severity of laboratory abnormalities related AEs on Day 3 after each dose of vaccination; [ Time Frame: Day 3 after each dose of vaccination ]
    Incidence and severity of laboratory abnormalities related AEs on Day 3 after each dose of vaccination;

  9. Phase I: Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) within 365 days after each dose of vaccination; [ Time Frame: within 365 days after each dose of vaccination ]
    Incidence and severity of serious adverse events (SAEs), adverse events of special interest (AESIs) and medically attended adverse events (MAAEs) within 365 days after each dose of vaccination;

  10. Phase II: Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination; [ Time Frame: Day 0 to Day 28 after each dose of vaccination ]
    Incidence and severity of all unsolicited AEs Day 0 to Day 28 after each dose of vaccination;

  11. Phase II: Incidence and severity of SAEs, AESIs, MAAEs within 365 days after each dose of vaccination; [ Time Frame: within 365 days after each dose of vaccination ]
    Incidence and severity of SAEs, AESIs, MAAEs within 365 days after each dose of vaccination;

  12. Phase II: GMT and seroconversion rate of total IgG antibodies (ELISA method) against the Alpha, Beta and Delta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination; [ Time Frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination ]
    GMT and seroconversion rate of total IgG antibodies against the Alpha, Beta and Delta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;

  13. Phase II: GMT of the neutralizing antibody titer (pseudoviral neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination; [ Time Frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination ]
    GMT of the neutralizing antibody titer (pseudoviral neutralization assay) against the Alpha and Beta variants of SARS-CoV-2 on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;

  14. Phase II: GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination; [ Time Frame: Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination ]
    GMT and seroconversion rate of neutralizing antibody (Live-virus neutralization assay) against the SARS-CoV-2 Alpha and Beta variants on Day 28, Day 90, Day 180 and Day 365 after the second dose of vaccination;

  15. Phase II: GMT of neutralizing antibody titers (pseudoviral neutralization assay) on Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination for other variants, such as Delta, Lambda and Gamma, etc. [ Time Frame: Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination ]
    Phase II: GMT of neutralizing antibody titers (pseudoviral neutralization assay) on Day 14, Day 28, Day 90, Day 180 and D365 after the second vaccination for other variants, such as Delta, Lambda and Gamma, etc.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05148091


Contacts
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Contact: Xinjie Yang, M.D. 86-010-58628288 xinjie_yang@sinocelltech.com
Contact: Lili Ma 86-010-58628288 lili_ma@sinocelltech.com

Locations
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China, Anhui
Anhui Provincial Hospital Not yet recruiting
Hefei, Anhui, China, 230001
Contact: Aizong Shen, M.D.         
China, Beijing
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Guiqiang Wang, M.D.         
Contact: Yimin Cui, M.D.         
Beijing Tongren Hospital, CMU Not yet recruiting
Beijing, Beijing, China, 100176
Contact: Xiuli Zhao, M.D.         
China, Hebei
PetroChina Central Hospital Recruiting
Langfang, Hebei, China, 050011
Contact: Kexin Zhao, M.D.    86-0316-2075450      
China, Hunan
Hunan Provincial Center for Disease Control And Prevention Not yet recruiting
Changsha, Hunan, China, 410005
Contact: Tao Huang, Ph.D.         
Sponsors and Collaborators
Sinocelltech Ltd.
Investigators
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Principal Investigator: Yimin Cui, M.D. Peking University First Hospital
More Information
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Responsible Party: Sinocelltech Ltd.
ClinicalTrials.gov Identifier: NCT05148091    
Other Study ID Numbers: SCTV01C-02-1
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: January 3, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
 Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases