Safety, Reactogenicity, and Immunogenicity Study of Heterologous Booster Vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510)
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| 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
Primary Outcome Measures
- 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 [Through Day 365 post last vaccination]
- GMT (Geometric Mean Titer) of SARS-CoV-2 RBD-binding antibody measured by ECLIA at each time point post heterologous booster vaccination [Through Day 365 post last vaccination]
- 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 [Through Day 365 post last vaccination]
- 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 [Through Day 365 post last vaccination]
- 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 [Through Day 365 post last vaccination]
- 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 [Through Day 365 post last vaccination]
- 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 [Through Day 365 post last vaccination]
- (Only applicable to CMI analysis set) Cell-mediated immunity assessment using IFN-γ ELISpot at each time point post heterologous booster vaccination [Through Day 365 post last vaccination]
Secondary Outcome Measures
- Occurrence of immediate systemic reactions [in 30 minutes post heterologous booster vaccination]
- Occurrence of solicited local AEs during 7 days post heterologous booster vaccination [Through 7 days post-vaccination]
- Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination [Through 7 days post-vaccination]
- Occurrence of unsolicited AEs during 28 days post heterologous booster vaccination [Through 28 days post-vaccination]
- Occurrence of SAEs, MAAEs and AESIs during the study period [Through Day 0 to Day 365 post vaccination]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participant must be 19 to 49 years of age inclusive, at the time of signing the informed consent.
-
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.
-
Participants who are able to attend all scheduled visits and comply with all study procedures.
-
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.
-
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.
-
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.
-
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:
-
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).
-
History of virologically-confirmed COVID-19, SARS or MERS disease.
-
History of congenital or acquired immunodeficiency or autoimmune disease.
-
History of bleeding disorder including thrombocytopenia which is judged by the investigator as a contraindication for intramuscular vaccination.
-
History of hypersensitivity and severe allergic reaction (e.g. anaphylaxis, Guillain-Barre syndrome) to any components of the study intervention.
-
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.)
-
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.
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Any other conditions which might interfere with the evaluation of the study objectives (e.g. alcohol or drug abuse, neurologic or psychiatric conditions).
-
Female participants who are pregnant or breastfeeding.
-
History of drug administration other than COVID-19 vaccination intended to treat or prevent COVID-19.
-
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).
-
Receipt of immunoglobulins, whole blood or blood products within 12 weeks prior to the study vaccination.
-
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.)
-
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.
-
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Korea University Ansan Hospital | Ansan | Korea, Republic of | ||
| 2 | Dong-A University Hospital | Busan | Korea, Republic of | ||
| 3 | Chungbuk National University Hospital | Cheongju-si | Korea, Republic of | ||
| 4 | Kyungpook National University Hospital | Daegu | Korea, Republic of | ||
| 5 | Chonnam National University Hospital | Gwangju | Korea, Republic of | ||
| 6 | Inha University Hospital | Incheon | Korea, Republic of | ||
| 7 | Hallym University Medical Center | Seoul | Korea, Republic of | ||
| 8 | Korea University Guro Hospital | Seoul | Korea, Republic of | ||
| 9 | Ajou University Hospital | Suwon | Korea, Republic of | ||
| 10 | Wonju Severance Christian Hospital | Wonju | Korea, Republic of |
Sponsors and Collaborators
- Korea University Guro Hospital
- Korean Center for Disease Control and Prevention
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIS_2021_001