Official Title
A Placebo-controlled, Randomized, Observer-blinded, Multi-center Study to Assess the Safety, Reactogenicity, and Immunogenicity of Booster Vaccination of A SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)
Brief Summary

This is randomized, placebo-controlled, observer-blinded, multi-center study to assesssafety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 19years and older who received a primary series of vaccination or the 1st boostervaccination against COVID-19 approved in Korea.

Detailed Description

The purpose of this study is to assess the safety, reactogenicity and immunogenicity of
booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510).

(Cohort 1~5) A total of approximately 550 adults will be divided into 5 cohorts based on
primary series vaccines they received - ChAdOx1 nCOV-19, BNT162b2, mRNA-1273, Ad26.COV2.S
and heterologous vaccination with ChAdOx1 nCOV-19 & BNT162b2.

(Cohort 6~7) A total of approximately 220 adults will be divided into 2 cohorts based on
primary series & 1st booster vaccines they received -mRNA vaccines (BNT162b2 or
mRNA-1273) and at least more than a single dose of non-mRNA vaccines (ChAdOx1 nCOV-19,
Ad26.COV2.S, and NVX-CoV2373)

The participants are then randomized at a ratio of 10:1 to either Test Group or Placebo
Group. Participants will be subject to follow-up for 12 months after receiving a single
booster dose of GBP510 adjuvanted with AS03.

Blood sampling for cell-mediated immunity will be undertaken on approximately 20% of the
participants in each cohort, who are selected in advance in consideration of the
randomization ratio between Test Group and Placebo Group.

Unknown status
COVID-19 (Healthy Volunteers)

Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03

SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug /
dose) Adjuvanted with AS03, 1 dose

Other: Normal saline

Normal saline

Eligibility Criteria

Inclusion Criteria:

1. Participant must be aged 19 years and older at the time of signing the informed
consent.

2. Participants who are healthy or medically stabilized according to medical judgment
of the investigator based on medical history, physical examination and clinical
laboratory tests, etc.

3. Participants who are able to attend all scheduled visits and comply with all study
procedures.

4. (Cohort 1~5) Participants who received a primary series of COVID-19 vaccination
approved for use in Korea by MFDS and at least 12~24 weeks have passed with no
additional COVID-19 vaccination.

5. (Cohort 6~7) Participants who received a primary series of COVID-19 vaccination and
the 1st booster vaccination at least 16 weeks ago through a homologous or
heterologous vaccination with mRNA vaccines (BNT162b2 (Pfizer) and mRNA-1273
(Moderna)) only or at least more than a single dose of non-mRNA vaccines (ChAdOx1
nCOV-19 (AZ), Ad26.COV2.S (Janssen), and NVX-CoV2373 (Novavax)).

6. Female participants of childbearing potential must agree to be heterosexually
inactive, or agree to use at least one acceptable method of contraception from at
least 4 weeks prior to the study vaccination (booster vaccination) to 12 weeks after
the study vaccination.

7. Female participants with a negative urine or serum pregnancy test at screening
(However, female participants who are surgically sterile or postmenopausal with
amenorrhea for at least 12 months shall be excluded.

8. Participants who give signed informed consent which include compliance with the
requirements and restrictions listed in the informed consent form and in the
protocol.

Exclusion Criteria:

1. Any clinically significant respiratory symptoms (e.g. cough, sore throat), febrile
illness (temperature >38°C), or acute illness within 72 hours prior to the study
vaccination (A prospective participant should not be included until 72 hours after
the condition has resolved).

2. History of virologically-confirmed COVID-19, SARS or MERS disease.

3. History of confirmed SARS-CoV-2 infection within three months before screening.

4. History of congenital or acquired immunodeficiency or autoimmune disease.

5. History of bleeding disorder including thrombocytopenia which is judged by the
investigator as a contraindication for intramuscular vaccination.

6. History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis,
Guillain-Barre syndrome) to any components of the study intervention.

7. History of malignancy within 1 year prior to the study vaccination (Except for a
participant judged by the investigator to have a low recurrence risk.)

8. Any other clinically significant conditions such as uncontrollable chronic or acute
diseases which, in the opinion of the investigator, might cause a health threat to
the participant or interfere with the clinical trial procedures or interpretation of
the study results.

9. Any other conditions which might interfere with the evaluation of the study
objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions).

10. Female participants who are pregnant or breastfeeding.

11. History of drug administration other than COVID-19 vaccination intended to treat or
prevent COVID-19.

12. History or planned other vaccination within 4 weeks prior to the study vaccination
through 28 days after the study vaccination (except for influenza vaccination, which
may be received at least 2 weeks prior to the study vaccination).

13. Receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to
the study vaccination.

14. Use of immunosuppressive therapy such as anti-cancer chemotherapy or radiation
therapy for at least 2 consecutive weeks within 12 weeks prior to the study
vaccination or long-term systemic corticosteroid therapy (e.g. ≥10mg prednisone/day
or equivalent for more than 2 consecutive weeks) (However, the use of topical and
nasal glucocorticoids will be permitted.)

15. History of participation in another clinical study within 4 weeks prior to the study
vaccination or planned participation in another clinical study during this study
period.

16. Investigators, study staff who are directly involved in the conduct of this study or
supervised by the investigator, or their family members.

Eligibility Gender
All
Eligibility Age
Minimum: 19 Years ~ Maximum: N/A
Countries
Korea, Republic of
Locations

Korea University Ansan Hospital
Ansan, Korea, Republic of

Dong-A University Hospital
Busan, Korea, Republic of

Chungbuk National University Hospital
Cheongju-si, Korea, Republic of

Kyungpook National University Hospital
Daegu, Korea, Republic of

Chonnam National University Hospital
Gwangju, Korea, Republic of

Hallym University Medical Center
Seoul, Korea, Republic of

Korea University Guro Hospital
Seoul, Korea, Republic of

Ajou University Hospital
Suwon, Korea, Republic of

Wonju Severance Christian Hospital
Wonju, Korea, Republic of

Not Provided

Korean Center for Disease Control and Prevention
NCT Number