COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05693272

Volker Gerdts

Not reported

2023-01-20

Not recruiting

RCT

Randomized

Sequential assignment

Blind label

multi-center

Prevention

inclusion criteria: male and female participants 18-65 years of age at the time of signing the informed consent form for the study. good general health as confirmed by assessments completed no more than 30 days before study d0. participants with mild to moderate well controlled comorbidities or having a medically stable condition, will be eligible. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization due to worsening during the 3 months prior to enrollment, and according to the judgment of the investigator, hospitalization during the entire study period is not anticipated. have received a minimum of 2 doses of an authorized covid-19 vaccine at least 4 months prior to the investigational booster dose injection. proof of vaccination can be provided as a digital copy of the vaccination receipt on the participant's device, a screenshot of the receipt on the device, or a printed paper copy. male participants, and heterosexually active females of child-bearing potential, must practice adequate contraception for 30 days prior to the injection and must agree to continue adequate contraception until 180 days after the injection. negative pregnancy test will be obtained from female participants of child-bearing potential at screening and at day 0. provide a written informed consent for the study prior to performing any study-related procedure. the investigator or a qualified designee must ensure the appropriate consent is in place.

presence of any febrile illness or any known or suspected acute illness on the day of immunization. clinically significant bleeding disorder (e.g., clotting factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injection or venipuncture. presence of an autoimmune disease. receiving systemic steroids in doses exceeding 20mg daily of prednisone or equivalent, for ≥ 14 days within 1 month, or has recently received any other cytotoxic or immunosuppressive drug within 6 months prior to the injection of the study vaccine. has a known malignancy diagnosed within the past 5 years. participants with basal cell carcinoma or squamous cell carcinoma of the skin are not excluded. currently receiving systemic immunomodulatory therapy or received chemotherapy within the last 5 years excluding topical agents. has received blood products or immunoglobulins (ivig or imig) within 3 months of study entry/baseline serologic evaluation. currently on anti-tuberculosis therapy. had sars-cov-2 infection within 4 months prior to study day 0. a potential participant is considered to have covid-19 infection base on one of the following: positive polymerase chain reaction (pcr) or rapid antigen test. documentation in a medical history report. reported by candidate. has received any non-covid-19 authorized vaccines (e.g., influenza) within 2 weeks prior to receiving study dose injection. has received any experimental sars-cov-2 / covid-19 vaccines receipt of sarscov-2/covid-19 vaccines that were experimental at the time of administration but are currently authorized, more than 6 months prior to day 0, will not lead to exclusion. planning to receive booster doses of any authorized covid-19 vaccine during the first two months days from study vaccination. abnormal laboratory test results (hematology, biochemistry, and urinalysis) as compared to the local normal lab ranges. to exclude transient abnormalities, laboratory tests may be repeated once. abnormal lab test results considered not clinically significant by the investigator will not be exclusionary. has a history of any reaction or known sensitivity likely to be exacerbated by any component of the study vaccine. is currently participating in or has participated in a study of an investigational agent within 6 months prior to the injection of the booster vaccine under study. a female is not eligible to participate if she is pregnant or breast feeding being a member of the study team, or an immediate family member or household member of a member on the study team. any condition, which in the opinion of the investigator may deem the participant inappropriate for the study.

4

University of Saskatchewan

18

65

Canada

Healthy volunteers

N/A

47

Assessment of the safety of COVAC-1 booster vaccine (10, 25 and 50 μg dosing of S1 antigen) in generally healthy volunteers

None

Phase 1

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