COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04702178

Not reported

Not reported

2021-01-08

Completed

RCT

Randomized

Sequential assignment

Blind label

multi-center

Prevention

inclusion criteria: to be eligible for the study, each participant must satisfy all of the following criteria: male and female healthy adults ages 18 years of age or older; good general health as determined by screening evaluation no greater than 30 days before immunization; if female of child-bearing potential and heterosexually active, practice of adequate contraception for 30 days prior to injection, negative pregnancy test on the day of injection, and agreement to continue adequate contraception until 180 days after the second injection and; written informed consent, after review of the consent form and having adequate opportunity to discuss the study with an investigator or a qualified designee.

participant with any of the following criteria will be excluded: presence of any febrile illness or any known or suspected acute illness on the day of any immunization; any physical findings suggestive of acute or chronic illness; any immunodeficiency (congenital or acquired); receiving systemic immunosuppressive therapy or history of receiving chemotherapy in last 5 years other than topical agents; receipt of systemic glucocorticoids (a dose ≥ 20 mg/day prednisone or equivalent for 14 days) within 1 month, or any other cytotoxic or immunosuppressive drug within 6 months; cancer diagnosis in the last 5 years, excluding basal cell and squamous cell carcinoma of the skin, which are allowed; presence of autoimmune disease; receipt of any investigational drug within 6 months; receipt of any non-covid-19 authorized vaccines within 2 weeks of study immunization; receipt of any authorized covid-19 vaccine prior to study enrollment; receipt of any other experimental sars-cov-2/covid-19 or other experimental coronavirus vaccine(s) at any time prior to or during the study; receipt of blood products or immunoglobulin (ivig or imig) within 3 months of study entry/baseline serologic evaluation; current anti-tuberculosis therapy; history of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine; hematologic or biochemical laboratory abnormalities (blood or urine), as defined by lab normal ranges. to exclude transient abnormalities, the investigator may repeat a test once, and if the repeat test is normal according to local reference ranges, participant may be enrolled. grade 1 abnormalities of laboratory values will not be exclusionary if considered not clinically significant by the investigator and; known current or previous laboratory-confirmed sars-cov-1 or sars-cov-2 infection, as documented by a positive polymerase chain reaction (pcr) test from a nasal swab or known or laboratory-confirmed positive serology.

10

University of Saskatchewan

18

100

Canada

Healthy volunteers

N/A

61

Occurrence of adverse events (AEs) from the first injection to Day 28, in all participants, in all groups;Occurrence of AEs from the second injection to Day 56 (28 days post injection), in all participants, in all groups

None

Phase 1

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