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

NCT05113849 | Unknown Phase 1 DMC

• 1 other identifier: IN_COV_101
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (11)

• 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

Study Arms (2)

Cohort A (Low-dose group)

EXPERIMENTAL

IN-B009 (Low-dose)

Biological: IN-B009 (Low-dose)

Cohort B (High-dose group)

EXPERIMENTAL

IN-B009 (High-dose)

Biological: IN-B009 (High-dose)

Interventions

IN-B009 (Low-dose) BIOLOGICAL

Two doses, intramuscular injection

Cohort A (Low-dose group)

IN-B009 (High-dose) BIOLOGICAL

Two doses, intramuscular injection

Cohort B (High-dose group)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• HK inno.N Corporation: lead

Study Sites (3)

Chungbuk National University Hospital

Chungju, South Korea

RECRUITING

Jeonbuk National University Hospital

Jeonju, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naree Shin, MS

CONTACT

+82-2-6477-0271; naree.shin@inno-n.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: November 9, 2021
• Study Start: September 16, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: November 9, 2021

Record last verified: 2021-11

Locations

KR (3)