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

Primary Purpose

COVID-19

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

IN-B009 (Low-dose)

IN-B009 (High-dose)

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Chungbuk National University HospitalRecruiting
Jeonbuk National University HospitalRecruiting
Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cohort A (Low-dose group)

Cohort B (High-dose group)

Arm Description

IN-B009 (Low-dose)

IN-B009 (High-dose)

Outcomes

Primary Outcome Measures

Occurrence rate of Immediate Adverse Reaction (IAR)

Occurrence rate of solicited local and systemic AE

Occurrence rate of unsolicited AE

Occurrence rate of SAEs, MAAEs, AESIs

GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA

GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA

Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer

GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay

GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay

Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer

Cell-mediated response

Secondary Outcome Measures

Full Information

NCT ID

NCT05113849

First Posted

October 29, 2021

Last Updated

November 8, 2021

Sponsor

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05113849

Brief Title

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

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 16, 2021 (Actual)

Primary Completion Date

February 2023 (Anticipated)

Study Completion Date

February 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

HK inno.N Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cohort A (Low-dose group)

Arm Type

Experimental

Arm Description

IN-B009 (Low-dose)

Arm Title

Cohort B (High-dose group)

Arm Type

Experimental

Arm Description

IN-B009 (High-dose)

Intervention Type

Biological

Intervention Name(s)

IN-B009 (Low-dose)

Intervention Description

Two doses, intramuscular injection

Intervention Type

Biological

Intervention Name(s)

IN-B009 (High-dose)

Intervention Description

Two doses, intramuscular injection

Primary Outcome Measure Information:

Title

Occurrence rate of Immediate Adverse Reaction (IAR)

Time Frame

Through 30 minutes post each vaccination (2 hours for sentinel participants)

Title

Occurrence rate of solicited local and systemic AE

Time Frame

Through Day 7 post each vaccination

Title

Occurrence rate of unsolicited AE

Time Frame

Through Day 28 post each vaccination

Title

Occurrence rate of SAEs, MAAEs, AESIs

Time Frame