This is a first-in-human, Phase I/II, randomized, placebo-controlled, observer-blinded, age-escalating study to assess the safety, reactogenicity and immunogenicity of a SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with Alum in healthy younger and older adults.
The purpose of this study is to assess the safety, reactogenicity and immunogenicity of the
candidate vaccine administered twice with 28-day interval in healthy adults including older
adults.
A total of 260 healthy younger and older adults will be enrolled to receive 2 doses of either
one GBP510 formulation (Test group 1 or 2) or placebo saline (Placebo group).
This study will consist of 2 stages, and a stepwise approach will be adopted as a safety
precaution. Approximately 60 healthy adults aged 19 to 55 years will be enrolled and
vaccinated first in Stage 1, and blinded safety data collected through 7 days after the last
study vaccination will be reviewed by the sponsor, and then by the independent Data Safety
Monitoring Board (DSMB) in an unblinded manner. Advancement to Stage 2 for further enrollment
of 200 healthy younger and older adults aged 19 to 85 years will be determined if an
acceptable safety profile is confirmed based on the sponsor and DSMB review. DSMB will
recommend whether to proceed to the next stage or not, and DSMB may suggest discontinuation
of the study or adjustment of dose and dosing regimen based on the safety review.
Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-10μg
Other: Normal saline (0.9% sodium chloride solution) - Stage 1
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-25μg
Other: Normal saline (0.9% sodium chloride solution) - Stage 1
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Biological: GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-10μg
Biological: GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2
Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
Other Name: GBP510-Alum-25μg
Other: Normal saline (0.9% sodium chloride solution)- Stage 2
Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria
apply:
Age
1. For Stage 1, participant must be 19 to 55 years of age inclusive, at the time of
signing the informed consent.
For Stage 2, participant must be 19 to 85 years of age inclusive, at the time of
signing the informed consent
Type of Participant and Disease Characteristics
2. Participants who are healthy as determined by medical evaluation including medical
history, physical examination, clinical laboratory tests, and medical judgement of the
investigator
3. Participants who are able to attend all scheduled visits and comply with all study
procedures.
Weight
4. Body mass index (BMI) within the range 18-30 kg/m2 at screening (inclusive)
Sex and Contraceptive/Barrier Requirements
5. 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 4 weeks prior to the 1st study vaccination to 12 weeks after the last
study vaccination
6. Female participants with a negative urine or serum pregnancy test at screening
Informed Consent
7. 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
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
1. 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.
2. History of virologically-confirmed COVID-19 disease, or definite or suspected exposure
to anyone known to have SARS-CoV-2 infection
3. History of virologically-confirmed SARS or MERS disease
4. History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease
5. Any positive test results for hepatitis B, C, or HIV at screening
6. History of bleeding disorder or thrombocytopenia which is contraindicating
intramuscular vaccination in the investigator's opinion
7. History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis,
Guillain-Barre syndrome) to any vaccines or components of the study intervention
8. History of malignancy within 5 years prior to the 1st study vaccination
9. 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)
10. History of, or planned surgery under general anesthesia from 1 year prior to the 1st
study vaccination through the study period
11. 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)
12. Female participants who are pregnant or breastfeeding
13. (Only for Stage 1) 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
14. Receipt of any medications or vaccinations intended to prevent COVID-19.
15. 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
16. Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to
the 1st study vaccination
17. 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
18. 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
19. Investigators, or study staff who are directly involved in the conduct of this study
or supervised by the investigator, and their respective family members.
20. Healthcare worker or emergency response personnel in an occupation with a high risk of
exposure to SARS-CoV-2
Korea University Ansan Hospital
Ansan, Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Chonnam National University Hospital
Gwangju, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Inha University Hospital
Incheon, Korea, Republic of
Ewha Womans University Medical Center
Seoul, Korea, Republic of
Hallym University Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Korea University Guro Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Hee Jin Cheong, Principal Investigator
Korea University Guro Hospital