a phase ⅱ clinical trial of recombinant corona virus disease-19 (covid-19) vaccine (sf9 cells)

Conditions: COVID-19

Summary: this is a phase ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant covid-19 vaccine (sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) with different immunization procedures (0, 21 days and 0, 14, 28 days) and doses (20μg/40μg).

this is a phase ⅱ, single-center, randomized, double-blind, placebo-controlled study, to evaluate the immunogenicity and safety of the recombinant covid-19 vaccine (sf9 cells) in the subjects from healthy adults and elderly adults aged 18 years and above (aged 18-60 and 60-85 years) . the phase ⅱ clinical trials designed 8 research group, including two immunization procedures (0, 21 days and 0, 14, 28 days), two doses (20μg/0.5ml, 40μg/1.0ml) and two ages group (adults and elder): each group including 120 participants. vaccination or placebo group will be randomly assigned to receive in a 5:1 ratio, 960 in total.

Eligibility criteria:
inclusion criteria: * aged 18 years and above. * able to understand the content of informed consent and willing to sign the informed consent. * able and willing to complete all the secluded study process during the whole study follow-up period (about 7 months). * axillary temperature ≤37.0℃. * general good health as established by medical history and physical examination. exclusion criteria: first dose exclusion criteria: * positive serum immunoglobulin m (igm) and igg to the sars-cov-2. * a known history of hiv infection * family history of seizure, epilepsy, brain or mental disease. * participant that has an allergic history to any ingredient of vaccines. * woman who is pregnant, breast-feeding or positive in pregnancy test on day of enrollment, or is planning to be pregnant during the next 6 months. * any acute fever disease or infections. * have a medical history of sars. * have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and not well-controlled. * major chronic illness, such as asthma, diabetes, or thyroid disease, and not well-controlled. * hereditary angioneurotic edema or acquired angioneurotic edema. * urticaria in last one year. * asplenia or functional asplenia. * platelet disorder or other bleeding disorder may cause injection contraindication. * faint at the sight of blood or needles. * prior administration of immunodepressant or corticosteroids, antianaphylactics treatment, cytotoxic treatment in last 6 months. * prior administration of blood products in last 4 months. * prior administration of other research medicines in last 1 month. * prior administration of attenuated vaccine in last 1 month. * prior administration of subunit vaccine or inactivated vaccine in last 14 days. * being treated for tuberculosis. * any condition that in the opinion of the investigators may interfere with the evaluation of study objectives. exclusion criteria for subsequent doses: * patients with severe allergic reactions after the previous dose of vaccination; * patients with serious adverse events causally related to the previous dose of vaccination.

Keywords: safety immunogenicity covid-19 vaccine recombinant vaccine