Safety and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults (COVID-19)

NCT04760743 | Completed Phase 1 DMC

• 1 other identifier: NBP2001_001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

This study is to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults.

Conditions

COVID-19 (Healthy Volunteers)

Outcome Measures

Primary Outcomes (12)

• Occurrence of immediate systemic reactions

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

• Occurrence of solicited local Adverse Events (AEs) during 7 days post each vaccination

  Through 7 days post-vaccination

• Occurrence of solicited systemic AEs during 7 days post each vaccination

  Through 7 days post-vaccination

• Occurrence of unsolicited AEs during 28 days post each vaccination

  Through 28 days post-vaccination

• Occurrence of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs) and Adverse Events of Special Interest (AESIs) during the whole study period

  Through Day 0 to Day 365 post last vaccination

• GMT of IgG antibody to the SARS-CoV-2 RBD measured by Enzyme-linked Immunosorbent Assay (ELISA)

  Through Day 365 post last vaccination

• GMFR of IgG antibody to the SARS-CoV-2 RBD from baseline measured by ELISA

  Through Day 365 post last vaccination

• Percentage of participants with ≥ 4-fold rise from baseline in ELISA IgG titer

  Through Day 365 post last vaccination

• GMT of neutralizing antibody to the SARS-CoV-2 measured by pseudovirus and wild-type virus neutralization assays

  Through Day 365 post last vaccination

• GMFR of neutralizing antibody to the SARS-CoV-2 from baseline measured by pseudovirus and wild-type virus neutralization assays

  Through Day 365 post last vaccination

• Percentage of participants with ≥ 4-fold rise from baseline in pseudovirus and wild-type neutralizing antibody titer

  Through Day 365 post last vaccination

• Cell-mediated response for both Th1 and Th2 (e.g. INF-γ, IL-4 using Enzyme-linked ImmunoSpot (ELISpot) or other system

  Through Day 28 post last vaccination

Study Arms (3)

low dose level cohort

EXPERIMENTAL

2 dose of NBP2001 adjuvanted with alum (Receptor Binding domain (RBD) 30μg/dose), 1 dose each on Day 0 and 28

Biological: NBP2001 adjuvanted with alum (RBD 30μg/dose)

high dose level cohort

EXPERIMENTAL

2 dose of NBP2001 adjuvanted with alum (Receptor Binding domain (RBD) 50μg/dose), 1 dose each on Day 0 and 28

Biological: NBP2001 adjuvanted with alum (RBD 50μg/dose)

Placebo group

PLACEBO COMPARATOR

2 doses of Placebo Saline, 1 dose each on Days 0 and 28.

Other: Normal Saline

Interventions

NBP2001 adjuvanted with alum (RBD 30μg/dose) BIOLOGICAL

Participants will receive intramuscular (IM) injections of NBP2001(RBD 30μg/dose) on Days 0 and 28.

low dose level cohort

NBP2001 adjuvanted with alum (RBD 50μg/dose) BIOLOGICAL

Participants will receive intramuscular (IM) injections of NBP2001(RBD 50μg/dose) on Days 0 and 28.

high dose level cohort

Normal Saline OTHER

Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.

Placebo group

Eligibility Criteria

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

You may qualify if:

• Age
• Participant must be 19 to 55 years of age inclusive, at the time of signing the informed consent.
• Type of Participant and Disease Characteristics
• Participants who are healthy as determined by medical evaluation including medical history, physical examination, clinical laboratory tests, and medical judgement of the investigator
• Participants who are able to attend all scheduled visits and comply with all study procedures.
• Weight
• Body mass index (BMI) within the range 18-30 kg/m2 at screening (inclusive)
• Sex and Contraceptive/Barrier Requirements
• Female participants of childbearing potential must agree to be heterosexually inactive, or agree to consistently use at least one acceptable method of contraception from at least 21 days prior to the 1st study vaccination to 8 weeks after the last study vaccination
• Female participants with a negative urine or serum pregnancy test at screening
• Informed Consent
• Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

You may not qualify if:

• Medical Conditions
• Any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile illness (tympanic temperature \>38°C), or acute illness within 72 hours prior to the 1st study vaccination. A prospective participant should not be included until 72 hours after the condition has resolved.
• History of virologically-confirmed COVID-19 disease, or definite or suspected exposure to anyone known to have SARS-CoV-2 infection
• History of virologically-confirmed SARS or MERS disease
• History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease
• Any positive test results for hepatitis B, C, or HIV at screening
• History of bleeding disorder or thrombocytopenia which is contraindicating intramuscular vaccination in the investigator's opinion
• History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any vaccines or components of the study intervention
• History of malignancy within 5 years prior to the 1st study vaccination
• Significant chronic illness that, in the opinion of the investigator, might increase risk of severe COVID-19, or interfere with the evaluation of the study objectives (e.g. asthma, chronic pulmonary disease, cardiovascular disease, chronic liver disease, diabetes mellitus, uncontrolled hypertension, renal disorders)
• History of, or planned surgery under general anesthesia from 1 year prior to the 1st study vaccination through the study period
• Any other conditions which, in the opinion of the investigator, might interfere with the evaluation of the study objectives (e.g. neurologic or psychiatric conditions)
• Female participants who are pregnant or breastfeeding
• Current smokers or a recent smoking history within 12 weeks prior to the 1st study vaccination. Occasional smokers who smoke up to 10 cigarettes per month may be allowed to participate at the investigator's discretion
• Prior/Concomitant therapy

Sponsors & Collaborators

• SK Bioscience Co., Ltd.: lead

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Bundang, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

COVID-19

Interventions

aluminum sulfate; Saline Solution

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

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Myoung-Don Oh

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 18, 2021
• Study Start: December 17, 2020
• Primary Completion: April 2, 2021
• Study Completion: March 2, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)