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Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)

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ClinicalTrials.gov Identifier: NCT05175950
Recruitment Status : Not yet recruiting
First Posted : January 4, 2022
Last Update Posted : January 4, 2022
Sponsor:
Collaborator:
Korean Center for Disease Control and Prevention
Information provided by (Responsible Party):
Hee Jin Cheong, Korea University Guro Hospital

Study Description
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Brief Summary:
This is Phase II, randomized, placebo-controlled, observer-blinded, multi-center study to assess safety, reactogenicity and immunogenicity of booster vaccination of a SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged between 19 and 49 inclusive who received a primary series of vaccination against COVID-19 approved in Korea.

Condition or disease Intervention/treatment Phase
COVID-19 (Healthy Volunteers) Biological: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 Other: Normal saline Phase 2

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).

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. 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test group 1: primary vaccination completed with ChAdOx1 nCOV-19
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
 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
Placebo Comparator: Placebo group 1: primary vaccination completed with ChAdOx1 nCOV-19
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
 Other: Normal saline
Normal saline
Experimental: Test group 2: primary vaccination completed with BNT162b2(Pfizer)
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
 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
Placebo Comparator: Placebo group 2: primary vaccination completed with BNT162b2(Pfizer)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
 Other: Normal saline
Normal saline
Experimental: Test group 3: primary vaccination completed with mRNA-1273(Moderna)
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
 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
Placebo Comparator: Placebo group 3: primary vaccination completed with mRNA-1273(Moderna)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
 Other: Normal saline
Normal saline
Experimental: Test group 4: primary vaccination completed with Ad26.COV2.S(Janssen)
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
 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
Placebo Comparator: Placebo group 4: primary vaccination completed with Ad26.COV2.S(Janssen)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
 Other: Normal saline
Normal saline
Experimental: Test group 5: primary vaccination completed with ChAdOx1 nCOV-19(AZ)-BNT162b2(Pfizer)
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
 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
Placebo Comparator: Placebo group 5: primary vaccination completed with ChAdOx1 nCOV-19-BNT162b2
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
 Other: Normal saline
Normal saline


Outcome Measures
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Primary Outcome Measures :
  1. Comparative GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 between the Test Group and Placebo Group, measured by wild-type virus neutralization assay at 2 weeks post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  2. GMT (Geometric Mean Titer) of SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  3. GMFR (Geometric Mean Fold Rise) of SARS-CoV-2 RBD-binding antibody from baseline measured by ECLIA at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  4. Percentage of participants with ≥4-fold rise from baseline in SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  5. GMT (Geometric Mean Titer) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  6. GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 from baseline measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  7. Percentage of participants with ≥4-fold rise from baseline in neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]
  8. (Only applicable to CMI analysis set) Cell-mediated immunity assessment using IFN-γ ELISpot at each time point post heterologous booster vaccination [ Time Frame: Through Day 365 post last vaccination ]

Secondary Outcome Measures :
  1. Occurrence of immediate systemic reactions [ Time Frame: in 30 minutes post heterologous booster vaccination ]
  2. Occurrence of solicited local AEs during 7 days post heterologous booster vaccination [ Time Frame: Through 7 days post-vaccination ]
  3. Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination [ Time Frame: Through 7 days post-vaccination ]
  4. Occurrence of unsolicited AEs during 28 days post heterologous booster vaccination [ Time Frame: Through 28 days post-vaccination ]
  5. Occurrence of SAEs, MAAEs and AESIs during the study period [ Time Frame: Through Day 0 to Day 365 post vaccination ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Participant must be 19 to 49 years of age inclusive, 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. 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. 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.
  6. 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.
  7. 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 congenital or acquired immunodeficiency or autoimmune disease.
  4. History of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination.
  5. History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any components of the study intervention.
  6. 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.)
  7. 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.
  8. Any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions).
  9. Female participants who are pregnant or breastfeeding.
  10. History of drug administration other than COVID-19 vaccination intended to treat or prevent COVID-19.
  11. 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).
  12. Receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination.
  13. 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.)
  14. 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.
  15. Investigators, study staff who are directly involved in the conduct of this study or supervised by the investigator, or their family members.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05175950


Contacts
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Contact: Hee Jin Cheong, Prof. 82-2-2626-3050 heejinmd@korea.ac.kr

Locations
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Korea, Republic of
Korea University Ansan Hospital
Ansan, Korea, Republic of
Contact: Won Suk Choi         
Dong-A University Hospital
Busan, Korea, Republic of
Contact: Dong Sik Jeong         
Chungbuk National University Hospital
Cheongju-si, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
Contact: Shin-Woo Kim         
Chonnam National University Hospital
Gwangju, Korea, Republic of
Contact: Kyung-Hwa Park         
Inha University Hospital
Incheon, Korea, Republic of
Hallym University Medical Center
Seoul, Korea, Republic of
Contact: Jacob Lee         
Korea University Guro Hospital
Seoul, Korea, Republic of
Contact: Hee Jin Cheong, Prof.         
Ajou University Hospital
Suwon, Korea, Republic of
Contact: Eun Jin Kim         
Wonju Severance Christian Hospital
Wonju, Korea, Republic of
Sponsors and Collaborators
Korea University Guro Hospital
Korean Center for Disease Control and Prevention
More Information
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Responsible Party: Hee Jin Cheong, Professor, Korea University Guro Hospital
ClinicalTrials.gov Identifier: NCT05175950    
Other Study ID Numbers: IIS_2021_001
First Posted: January 4, 2022    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No