COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05148091

Xinjie Yang, M.D.

xinjie_yang@sinocelltech.com

2021-12-08

Recruiting

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

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.

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.

5

Sinocelltech Ltd.

18

100

China

Healthy volunteers

N/A

752

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;;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;;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;;Phase II: Incidence and severity of solicited AEs from Day 0 to Day 7 after each dose of vaccination;;Phase I: Incidence and severity of adverse reactions (ARs) from Day 0 to Day 7 days after each dose of vaccination.

None

Phase 1/Phase 2

[{"arm_notes": "20\u00b5g;2;Days0-28;18-59 yo and \u226560 yo", "treatment_id": 1914, "treatment_name": "Sctv01c", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20\u00b5g;2;Days0-28;18-59 yo and \u226560 yo", "treatment_id": 2433, "treatment_name": "Sctv01c+sct-va02b adjuvant", "treatment_type": "Protein subunit+adjuvant", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40\u00b5g;2;Days0-28;18-59 yo and \u226560 yo", "treatment_id": 1914, "treatment_name": "Sctv01c", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "40\u00b5g;2;Days0-28;18-59 yo and \u226560 yo", "treatment_id": 2433, "treatment_name": "Sctv01c+sct-va02b adjuvant", "treatment_type": "Protein subunit+adjuvant", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]