AzTrials
AzTrials

COVID-19 (Healthy Volunteers)Phase 1NCT04760743

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

A Phase 1 study testing NBP2001 adjuvanted with alum (RBD 30μg/dose), NBP2001 adjuvanted with alum (RBD 50μg/dose) and Normal Saline in people with COVID-19 (Healthy Volunteers), run by SK Bioscience Co., Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19 (Healthy Volunteers)
What is being tested?
NBP2001 adjuvanted with alum (RBD 30μg/dose), NBP2001 adjuvanted with alum (RBD 50μg/dose) and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
2 sitesSouth Korea
Study dates
17 Dec 2020to 2 Mar 2022
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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.

Who cannot join

  • 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
Show all 24Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Bundang

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
NBP2001 adjuvanted with alum (RBD 30μg/dose), NBP2001 adjuvanted with alum (RBD 50μg/dose), Normal Saline
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

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

  • Normal SalineOther

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

Study groups in NCT04760743
Study groupRoleWhat they receive
low dose level cohortExperimental2 dose of NBP2001 adjuvanted with alum (Receptor Binding domain (RBD) 30μg/dose), 1 dose each on Day 0 and 28
Receives: Biological: NBP2001 adjuvanted with alum (RBD 30μg/dose)
high dose level cohortExperimental2 dose of NBP2001 adjuvanted with alum (Receptor Binding domain (RBD) 50μg/dose), 1 dose each on Day 0 and 28
Receives: Biological: NBP2001 adjuvanted with alum (RBD 50μg/dose)
Placebo groupPlacebo comparator2 doses of Placebo Saline, 1 dose each on Days 0 and 28.
Receives: Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of immediate systemic reactions

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

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

    Measured: Through 7 days post-vaccination

  3. Occurrence of solicited systemic AEs during 7 days post each vaccination

    Measured: Through 7 days post-vaccination

  4. Occurrence of unsolicited AEs during 28 days post each vaccination

    Measured: Through 28 days post-vaccination

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

    Measured: Through Day 0 to Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 365 post last vaccination

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

    Measured: Through Day 28 post last vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Feb 2021
  2. Study start17 Dec 2020
  3. Primary completion2 Apr 2021
  4. Study completion2 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04760743
Sponsor's protocol ID
NBP2001_001
Status last verified
Apr 2023
First submitted
17 Feb 2021
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NBP2001 adjuvanted with alum (RBD 30μg/dose), NBP2001 adjuvanted with alum (RBD 50μg/dose) and Normal Saline in people with COVID-19 (Healthy Volunteers), run by SK Bioscience Co., Ltd. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of immediate systemic reactions (time frame: Through 30 minutes (2 hours for sentinel participants) post-vaccination). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04760743.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in