Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)

COVID-19 Clinical Trial

Official title:

A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113849
• Other study ID #: IN_COV_101
• Status: Recruiting
• Phase: Phase 1
• Start date: September 16, 2021
• Est. completion date: February 2023

Study information

• Verified date: November 2021
• Source: HK inno.N Corporation
• Contact: Naree Shin, MS
• Phone: +82-2-6477-0271
• Email: naree.shin[@]inno-n.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a first in human, phase I, open-label, dose-escalation study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in healthy adults.

Description:

Total of 40 participants will be enrolled in 3 institutions : Seoul National University Hospital, Jeonbuk National University Hospital, and Chungbuk National University Hospital. Safety, reactogenicity, and immunogenicity will be evaluated in healthy participants with administration of IN-B009 (Injected twice, 21-day-interval).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• IN-B009 (Low-dose)
Two doses, intramuscular injection
• IN-B009 (High-dose)
Two doses, intramuscular injection

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Chungju
Korea, Republic of	Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
HK inno.N Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence rate of Immediate Adverse Reaction (IAR)		Through 30 minutes post each vaccination (2 hours for sentinel participants)
Primary	Occurrence rate of solicited local and systemic AE		Through Day 7 post each vaccination
Primary	Occurrence rate of unsolicited AE		Through Day 28 post each vaccination
Primary	Occurrence rate of SAEs, MAAEs, AESIs		Through Day 365 post last vaccination
Primary	GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA		Through Day 365 post last vaccination
Primary	GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA		Through Day 365 post last vaccination
Primary	Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer		Through Day 365 post last vaccination
Primary	GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay		Through Day 365 post last vaccination
Primary	GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay		Through Day 365 post last vaccination
Primary	Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer		Through Day 365 post last vaccination
Primary	Cell-mediated response		Through Day 28 post last vaccination