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

Primary Purpose

COVID-19 (Healthy Volunteers)

Status

Completed

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

NBP2001 adjuvanted with alum (RBD 30μg/dose)

NBP2001 adjuvanted with alum (RBD 50μg/dose)

Normal Saline

About this trial

This is an interventional prevention trial for COVID-19 (Healthy Volunteers)

Eligibility Criteria

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

Inclusion Criteria:

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.

Exclusion Criteria:

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
Receipt of any medications or vaccinations intended to prevent COVID-19.
Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned receipt of any vaccine from enrollment through 28 days after the last study vaccination (Visit 7), except for influenza vaccination, which may be received at least 2 weeks prior to the 1st study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to the 1st study vaccination
Chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (≥10mg prednisone/day or equivalent for more than 2 consecutive weeks) within 12 weeks prior to the 1st vaccination. The use of topical and nasal glucocorticoids will be permitted.
Prior/Concurrent Clinical Study Experience
Participation in another clinical study involving study intervention within 6 months prior to the 1st study vaccination, or concurrent, planned participation in another clinical study with study intervention during this study period.
Other Exclusions
Investigators, or study staff who are directly involved in the conduct of this study or supervised by the investigator, and their respective family members.
Healthcare worker or emergency response personnel in an occupation with a high risk of exposure to SARS-CoV-2

Sites / Locations

Seoul National University Bundang Hospital
Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

low dose level cohort

high dose level cohort

Placebo group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Occurrence of immediate systemic reactions

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

Occurrence of solicited systemic AEs during 7 days post each vaccination

Occurrence of unsolicited AEs during 28 days post each vaccination

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

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

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

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

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

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04760743

First Posted

February 17, 2021

Last Updated

April 16, 2023

Sponsor

SK Bioscience Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04760743

Brief Title

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

Official Title

A Phase I, Placebo-controlled, Randomized, Observer-blinded, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (NBP2001) in Healthy Adults Aged at 19 to 55 Years

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

December 17, 2020 (Actual)

Primary Completion Date

April 2, 2021 (Actual)

Study Completion Date

March 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Bioscience Co., Ltd.

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

Detailed Description

This is a first-in-human, Phase I, randomized, placebo-controlled, observer-blinded study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein subunit vaccine (NBP2001) in healthy adults. A total of 50 healthy adults between 19 and 55 years of age will be enrolled and block-randomized in a 4:1 ratio to receive 2 doses of either one NBP2001 formulation (Test group 1 or 2) or placebo saline (Placebo group). Over the study period, participants will commonly attend 10 planned visits. Telephone calls will be made 7 days after each vaccination (Day 7+3 after Visit 2 and Visit 4). However, sentinel participants will be required to return at Day 7(+ 3 days) after 1st vaccination for rigorous safety assessment. Study vaccination will comprise 2 intramuscular injections of saline placebo, or a 30 or 50μg dose of NBP2001 in an injection volume of approximately 0.5mL. The study vaccines will be injected preferably into the deltoid muscle of the upper arm at a 28-day interval. Halting rules based on reactogenicity and safety outcomes are defined, and enrollment and study vaccination may be paused during the study if any halting rules are met.

6. Conditions and Keywords

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

COVID-19 (Healthy Volunteers)

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

low dose level cohort

Arm Type

Experimental

Arm Description

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

Arm Title

high dose level cohort

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

NBP2001 adjuvanted with alum (RBD 30μg/dose)

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NBP2001 adjuvanted with alum (RBD 50μg/dose)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Normal Saline

Intervention Description

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

Primary Outcome Measure Information:

Title

Occurrence of immediate systemic reactions

Time Frame

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

Title

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

Time Frame

Through 7 days post-vaccination

Title

Occurrence of solicited systemic AEs during 7 days post each vaccination

Time Frame

Through 7 days post-vaccination

Title

Occurrence of unsolicited AEs during 28 days post each vaccination

Time Frame

Through 28 days post-vaccination

Title

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

Time Frame

Through Day 0 to Day 365 post last vaccination

Title

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

Time Frame