COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05492643

Jianying Huang

znyylcsy@126.com

2022-08-08

Recruiting

nonRCT

Non-randomized

Parallel

Open label

single-center

Prevention

inclusion criteria: adults aged 18 years and older; vaccinated with 2 or 3 doses of marketed inactivated sars-cov-2 vaccine according to national immunization planning, whose last dose was given at least 6 months ago; willing and able to comply with study requirements, and other study procedures within 6 months after vaccination; female participants or partners of male participants of childbearing potential: from the first day of last menstruation cycle to the day of enrolment, must had no sexual behavior with a male or had effective contraceptive methods without failure; voluntarily agree to maintain abstinent or use effective contraception with their partners until 6 months after vaccination; based on medical history enquiry, physical examination, and blood routine examination, the investigator judges the participants as in a healthy status; participants with mild underlying disease (for example chonic diseases like diabetes/hypertension/hyperlipemia, etc.) must be in a stable state without exacerbation (no admission to hospital or no major adjustment to treatment regimen, etc.) for at least 3 months prior to enrollment in this study. understand the contents of the icf and voluntarily sign it.

1.received any licensed sars-cov-2 vaccines other than inactivated sars-cov-2 vaccine). 2.history of severe acute respiratory syndrome (sars), or sars-cov-2 infections. 3.history of allergy to any component of the study vaccine or history of severe allergic reaction to the vaccine or drug (including but not limited to anaphylaxis, allergic laryngeal oedema, anaphylactic purpura, thrombocytopenic purpura, or localized allergic necrosis (arthus reaction)). 4.positive sars-cov-2 rt-pcr results. 5.axillary temperature ≥37.3°c at enrolment or 24 hours prior to vaccination. 6.had a history of human immuno-deficiency virus(hiv) infection or positive hiv test result before enrolment. 7.a history or family history of convulsions, epilepsy, encephalopathy and psychosis. 8.malignant tumors in the active phase, malignant tumors not receiving adequate treatment, malignant tumors at potential risk of recurrence during the study period. 9.with severe or un-controllable cardiovascular disease, thrombotic disease, neurological disease, blood and lymphatic system disease, liver and kidney disease, respiratory system disease, metabolic, skeletal muscular disease and autoimmune disease. 10.congenital or functional splenic deficiency, complete or partial splenectomy for any reason. 11.prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs (e.g., corticosteroids, ≥20 mg/d prednisone or equivalent; however, inhaled and topical steroids are permitted) within 6 months prior to the vaccine. 12.any other inactivated vaccines given within 7 days prior to the study vaccination, or live-attenuated vaccines within 14 days prior to the study vaccination. 13.have received immunoglobulin or other blood products within 3 months prior to enrollment or plan to receive them during the study period. 14.blood donation or blood loss ≥ 450 ml within 1 month prior to enrolment, or planned donation during the study period. 15.is currently in or intent to participate in another clinical study at any time during the conduct of this study. 16.for women of childbearing potential (wocbp): with a positive urine pregnancy test before vaccination; pregnant or lactating; or have a plan to become pregnant within 6 months after enrolment. for male participants whose partner is wocbp: whose partner has a plan to become pregnant within 6 months after her partner's enrolment. 17.with a history of intramuscular injection contraindication. for example: diagnosed thrombocytopenia, and coagulation disorder or received anticoagulation therapy. 18.participants deemed unsuitable for participation in this study based on the investigator's assessment.

2

Zhongnan Hospital

18

100

China

Healthy volunteers

N/A

1000

Primary Immunogenicity Endpoint;Primary Safety Endpoint

None

Not reported

[{"arm_notes": "received 2 doses", "treatment_id": 2449, "treatment_name": "Sys6006", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "received 3 doses", "treatment_id": 2449, "treatment_name": "Sys6006", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]