COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04742738

Hee Jin Cheong

Yoonyeong Lee, yoonyeong@sk.com (PI email not reported)

2021-02-08

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria participants are eligible to be included in the study only if all of the following criteria apply: age for stage 1, participant must be 19 to 55 years of age inclusive, at the time of signing the informed consent. for stage 2, participant must be 19 to 85 years of age inclusive, at the time of signing the informed consent type of participant and disease characteristics participants who are healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and medical judgement of the investigator participants who are able to attend all scheduled visits and comply with all study procedures. weight body mass index (bmi) within the range 18-30 kg/m2 at screening (inclusive) sex and contraceptive/barrier requirements female participants of childbearing potential must agree to be heterosexually inactive, or agree to consistently use at least one acceptable method of contraception from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last study vaccination female participants with a negative urine or serum pregnancy test at screening informed consent capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol. exclusion criteria participants are excluded from the study if any of the following criteria apply: medical conditions any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic temperature >38°c), or acute illness within 72 hours prior to the 1st study vaccination. a prospective participant should not be included until 72 hours after the condition has resolved. history of virologically-confirmed covid-19 disease, or definite or suspected exposure to anyone known to have sars-cov-2 infection history of virologically-confirmed sars or mers disease history of congenital, hereditary, acquired immunodeficiency, or autoimmune disease any positive test results for hepatitis b, c, or hiv at screening history of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion history of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, guillain-barre syndrome) to any vaccines or components of the study intervention history of malignancy within 5 years prior to the 1st study vaccination significant chronic illness that, in the opinion of the investigator, might increase risk of severe covid-19, or interfere with the evaluation of the study objectives (e.g. asthma, chronic pulmonary disease, cardiovascular disease, chronic liver disease, diabetes mellitus, uncontrolled hypertension, renal disorders) history of, or planned surgery under general anesthesia from 1 year prior to the 1st study vaccination through the study period any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g. neurologic or psychiatric conditions) female participants who are pregnant or breastfeeding (only for stage 1) current smokers or a recent smoking history within 12 weeks prior to the 1st study vaccination. occasional smokers who smoke up to 10 cigarettes per month may be allowed to participate at the investigator's discretion prior/concomitant therapy receipt of any medications or vaccinations intended to prevent covid-19. receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine from enrollment through 28 days after the last study vaccination (visit 7), except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination. this exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the 1st study vaccination chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the 1st vaccination. the use of topical and nasal glucocorticoids will be permitted. prior/concurrent clinical study experience participation in another clinical study involving study intervention within 6 months prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period. other exclusions investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members. healthcare worker or emergency response personnel in an occupation with a high risk of exposure to sars-cov-2

None

5

SK Bioscience Co., Ltd.

19

85

Korea;Republic of

Healthy volunteers

N/A

260

Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system) - Stage 2;GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA - Stage 2;GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays - Stage 2;GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA) - Stage 2;GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays - Stage 2;Occurrence of immediate systemic reactions - Stage 1;Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period - Stage 1;Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination - Stage 1;Occurrence of solicited systemic AEs during 7 days post each vaccination - Stage 1;Occurrence of unsolicited AEs during 28 days post each vaccination - Stage 1;(Only in Sentinel group) Occurrence of out-of-normal range clinical laboratory test results (including change from baseline values) during 7 days post 1st vaccination - Stage 1;Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer - Stage 2;Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer - Stage 2

None

Phase 1/Phase 2

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