Clinical trial NCT05113849: Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: COVID-19
Lead sponsor: HK inno.N Corporation
Sponsor class: INDUSTRY
First posted: 2021-11-09
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence rate of Immediate Adverse Reaction (IAR)
timeFrame: Through 30 minutes post each vaccination (2 hours for sentinel participants)
measure: Occurrence rate of solicited local and systemic AE
timeFrame: Through Day 7 post each vaccination
measure: Occurrence rate of unsolicited AE
timeFrame: Through Day 28 post each vaccination
measure: Occurrence rate of SAEs, MAAEs, AESIs
timeFrame: Through Day 365 post last vaccination
measure: GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA
timeFrame: Through Day 365 post last vaccination
measure: GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA
timeFrame: Through Day 365 post last vaccination
measure: Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer
timeFrame: Through Day 365 post last vaccination
measure: GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
timeFrame: Through Day 365 post last vaccination
measure: GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay
timeFrame: Through Day 365 post last vaccination
measure: Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer
timeFrame: Through Day 365 post last vaccination
measure: Cell-mediated response
timeFrame: Through Day 28 post last vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: In Jin Jang
role: PRINCIPAL_INVESTIGATOR
affiliation: Jeonju National University Hospital
name: Min Geol Kim
role: PRINCIPAL_INVESTIGATOR
affiliation: Chungbuk National University Hospital
name: Jun Ki Hwang
role: PRINCIPAL_INVESTIGATOR
References: