COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05113849

Naree Shin, MS

naree.shin@inno-n.com

2021-11-09

Recruiting

nonRCT

Non-randomized

Sequential assignment

Open label

multi-center

Prevention

inclusion criteria: - male or female participants between the ages of 18 and 55 years. - participants considered 'healthy' to be eligible for study participation. - participants who are willing and able to comply with all scheduled visits and other study procedures. - participants with body mass index (bmi) within the normal range. - participants with deltoid muscle capable of ip injection. - those that agreed to using medically approved contraception. - female participants with potential pregnancy- those that used medically approved contraception and has negative result at the pregnancy test. - capable of giving personal signed informed consent

- clinically significant symptoms prior to ip injection. - confirmed to be covid-19 rt-pcr positive or to have made close contact with sars-cov-2 infected patient. - history of virologically-confirmed sars, mers, or covid-19. - history of congenital or acquired immunodeficiency or autoimmune diseases. - positive result of hepatitis b, c, rpr test, or hiv. - history of disorder that inhibits intramuscular injection of the vaccine. - history of hypersensitivity and severe allergic reaction to any of the components of ip. - history of malignant tumor within 5 years prior to the first ip injection. - clinically significant chronic diseases that could cause safety concerns regarding covid-19. - scheduled of , or history of surgery under general anaesthesia prior to first ip injection, - female participant that is pregnant or is currently breastfeeding. - smoker or history of smoking within 12 weeks prior to first ip injection. - previous vaccination or treatment for prevention of covid-19. - vaccination prior to the first ip injection or scheduled of vaccination after second ip injection. - treated with immunoglobulin and/or blood/blood components prior to first ip injection. - chronic use of immunosuppressant prior to first ip injection. - participated in other clinical study prior to first ip injection, or scheduled to participate in other study during the study period. - healthcare worker or emergency response personnel. - conditions that may influence the evaluation of the study objectives.

2

HK inno.N Corporation

19

55

Korea;Republic of

Healthy volunteers

N/A

40

Cell-mediated response;GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA;GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay;GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA;GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay;Occurrence rate of Immediate Adverse Reaction (IAR);Occurrence rate of SAEs, MAAEs, AESIs;Occurrence rate of solicited local and systemic AE;Occurrence rate of unsolicited AE;Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer;Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer

None

Phase 1

[{"arm_notes": "High-dose;2;IM", "treatment_id": 2051, "treatment_name": "In-b009", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "Low-dose;2;IM", "treatment_id": 2051, "treatment_name": "In-b009", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]