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)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 770
- 试验地点
- 9
- 主要终点
- 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
研究概览
简要总结
This is 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 19 years and older who received a primary series of vaccination or the 1st booster vaccination against COVID-19 approved in Korea.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant must be aged 19 years and older 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.
- •(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.
- •(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)).
- •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.
排除标准
- •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 confirmed SARS-CoV-2 infection within three months before screening.
- •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.
- •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-
- •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.
研究组 & 干预措施
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
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 1: primary vaccination completed with ChAdOx1 nCOV-19
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
Test group 2: primary vaccination completed with BNT162b2(Pfizer)
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 2: primary vaccination completed with BNT162b2(Pfizer)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
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
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 3: primary vaccination completed with mRNA-1273(Moderna)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
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
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 4: primary vaccination completed with Ad26.COV2.S(Janssen)
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
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
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 5: primary vaccination completed with ChAdOx1 nCOV-19-BNT162b2
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
Test group 6: primary and 1st booster vaccination completed with mRNA vaccine
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 6: primary and 1st booster vaccination completed with mRNA vaccine
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
Test group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccine
GBP510 adjuvanted with AS03 (Receptor Binding Domain (RBD) 25μg/dose), 1 dose on Days 0
干预措施: SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) (RBD of SARS-CoV-2 25ug / dose) Adjuvanted with AS03 (Biological)
Placebo group 7: primary and 1st booster vaccination completed with ≥1 dose of non-mRNA vaccine
Participants will receive intramuscular (IM) injections of Normal saline on Days 0
干预措施: Normal saline (Other)
结局指标
主要结局
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
时间窗: 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
时间窗: Through Day 365 post last vaccination
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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Through Day 365 post last vaccination
次要结局
- Occurrence of solicited systemic AEs during 7 days post heterologous booster vaccination(Through 7 days post-vaccination)
- 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 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)
研究者
Hee Jin Cheong
Professor
Korea University Guro Hospital