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

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

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19
• Intervention / Treatment: Biological: IN-B009 (Low-dose); Biological: IN-B009 (High-dose)

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).

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Naree Shin, MS; Phone Number: +82-2-6477-0271; Email: naree.shin@inno-n.com

Study Locations

• Korea, Republic of
  • Chungju, Korea, Republic of
    • Recruiting
    • Chungbuk National University Hospital
    • Contact: Min-Gul Kim, MD, PhD
  • Jeonju, Korea, Republic of
    • Recruiting
    • Jeonbuk National University Hospital
    • Contact: Jun Ki Hwang, MD, PhD
  • Seoul, Korea, Republic of
    • Recruiting
    • Seoul National University Hospital
    • Contact: In-Jin Jang, MD, PhD; Phone Number: +82-2-2072-1910; Email: ijjang@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A (Low-dose group); IN-B009 (Low-dose)	Biological: IN-B009 (Low-dose); Two doses, intramuscular injection
Experimental: Cohort B (High-dose group); IN-B009 (High-dose)	Biological: IN-B009 (High-dose); Two doses, intramuscular injection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: HK inno.N Corporation
• Investigators: Principal Investigator: In Jin Jang, Seoul National University Hospital; Principal Investigator: Min Geol Kim, Jeonju National University Hospital; Principal Investigator: Jun Ki Hwang, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2021
• Primary Completion (Anticipated): February 1, 2023
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: November 8, 2021
• First Posted (Actual): November 9, 2021

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: IN_COV_101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No