COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05679466

Not reported

Not reported

2023-01-11

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

inclusion criteria: 1.adults aged 18 years and older. 2.previous completion of 2 or 3 doses of inactivated covid-19 vaccine and compliance with the vaccination procedures in the current instructions. the last dose of vaccination is 6 to 18 months (180 to 540 days, including the threshold) after the investigational vaccination, and proof of previous vaccination can be provided. 3.understand the content of the icf, and voluntarily sign the icf. 4.participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures. 5.healthy participants or participants with mild underlying disease [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]. 6.female participants surgically sterilized or ≥ 2 years post-menopause, or negative urine pregnancy test and willing to use effective contraception (e.g., condoms, iuds) within 90 days of investigational vaccination. contraceptive use is not allowed. consent to not breastfeed during the study and for at least 90 days after investigational vaccination。 male participants subjects of childbearing potential who agree to use effective contraception (e.g., condoms, spermicide) within 90 days of study vaccination.

1.positive sars-cov-2 antigen during the screening period. 2.history of sars, mers, covid-19 or known asymptomatic sars-cov-2 infection within 6 months prior to screening. 3.fever (axillary temperature ≥37.3 ℃) within 72 hours prior to vaccination. 4.history of severe allergy to any component of the experimental vaccine, including adjuvant components (squalene, alpha-tocopherol, and polysorbate 80, etc.), such as anaphylaxis, anaphylactic laryngeal edema, anaphylactic purpura, thrombocytopenic purpura, local anaphylactic necrotizing reaction (arthus reaction); or previous history of severe side effects of any vaccine or drug, such as: allergy, urticaria, skin eczema, dyspnea, angioneurotic edema, etc. 5.currently suffering from acute infectious diseases or in the active stage of chronic infectious diseases, including but not limited to hepatitis b, hepatitis c. 6.current cancer, immune disorders (e.g., human immunodeficiency virus [hiv] infection, systemic lupus erythematosus, rheumatoid arthritis, absence of spleen or splenectomy, and other immune disorders that the investigator believes may have an impact on immune response), etc.; current other serious chronic diseases such as unstably controlled hypertension, asthma, heart disease, diabetes, liver or kidney disease, thyroid disease, hematologic system disorders (coagulation disorders or bleeding tendency), neurological/psychiatric disorders such as convulsions, epilepsy, etc. 7.undergoing anti-tuberculosis treatment. 8.prolonged (defined as more than 14 days) use of immunosuppressive or other immunomodulatory drugs, anti-allergy therapy, or cytotoxic therapy within 6 months prior to the vaccine. inhaled/nebulized, intra-articular, intradural, or topical (skin or eyes) corticosteroids are permitted. topical doses should not exceed the recommended dose of the drug instructions. 9.have received blood products within 3 months prior to enrollment or plan to receive them during the study period. 10.participants who have received any other investigational product within 1 month prior to enrollment or intent to receive other investigational products during the study period. 11.received an inactivated vaccine or protein vaccine within 14 days prior to enrollment, or a live attenuated vaccine or adenovirus vector vaccine within 1 month, or intent to receive any other vaccine (except seasonal influenza vaccine or vaccine requiring emergency vaccination) during the study period. participants deemed unsuitable for participation in this study based on the investigator's assessment.

2

Yu Qin

18

100

China

Healthy volunteers

N/A

3300

AE associated with investigational vaccine;solicited (local and systemic) AE;unsolicited AE

None

Phase 1

[{"arm_notes": "nan", "treatment_id": 1091, "treatment_name": "Recov - recombinant two-component covid-19 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]