A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 2,848
- 试验地点
- 1
- 主要终点
- Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
研究概览
简要总结
The aim of the study is to assess the safety, and immunogenicity of AZD2816 for the prevention of COVID-19
详细描述
The purpose of this study is to demonstrate the safety and characterize the immunogenicity of AZD2816; AstraZeneca's candidate ChAdOx1 vector vaccine against SARS-CoV-2 variant strain B.1.351
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)
盲法说明
Double Blind: two or more parties are unaware of the intervention assignment.
入排标准
- 年龄范围
- 18 Years 至 115 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult, ≥ 18 years of age at the time of consent
- •For inclusion in the SARS-CoV-2 seronegative population:
- •No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid amplification test and no positive antibody test).
- •Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the nucleoprotein).
- •Medically stable such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up
- •Able to understand and comply with study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative) based on the assessment of the investigator
- •Signed informed consent obtained before conducting any study-related procedures
- •Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •Previously COVID-19 Vaccinated Participants:
- •Prior completion of a 2-dose primary homologous vaccination regimen against SARSCoV-2 with either AZD1222 (2 standard doses as authorized vaccine or as investigational product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine approved for emergency or conditional use. The second dose in all cases should have been administered at least 3 months prior to first administration of study intervention.
排除标准
- •History of allergy to any component of AZD1222/AZD
- •History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition
- •Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization
- •Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or HIV/AIDS.
- •Recurrent severe infections and use of immunosuppressant medication within the past 6 months (≥ 20 mg per day of prednisone or its equivalent, given daily or on alternate days for ≥ 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days)
- •History of primary malignancy (see protocol)
- •History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine
- •History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-β2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria.
- •Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture
- •Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged by the Investigator
- •Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data
- •Any autoimmune conditions, except mild psoriasis and vitiligo.
研究组 & 干预措施
Primary Vaccination Cohort:- AZD1222 (4)
Previously unvaccinated participants received intramuscular (IM) AZD1222 5*10^10 viral particles (vp) on Days 1 and 29 (4-week dosing interval).
干预措施: AZD1222 (Biological)
Primary Vaccination Cohort:- AZD2816 (4)
Previously unvaccinated participants received IM AZD2816 5*10^10 vp on Days 1 and 29 (4-week dosing interval).
干预措施: AZD2816 (Biological)
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Previously unvaccinated participants received IM AZD1222 5*10^10 vp on Day 1 and IM AZD2816 5*10^10 vp on Day 29 (4-week dosing interval).
干预措施: AZD1222 (Biological)
Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)
Previously unvaccinated participants received IM AZD1222 5*10^10 vp on Day 1 and IM AZD2816 5*10^10 vp on Day 29 (4-week dosing interval).
干预措施: AZD2816 (Biological)
Primary Vaccination Cohort:- AZD2816 (12)
Previously unvaccinated participants received IM AZD2816 5*10^10 vp on Days 1 and 85 (12-week dosing interval).
干预措施: AZD2816 (Biological)
Booster Cohort:- AZD1222:AZD1222
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5*10^10 vp on Day 1.
干预措施: AZD1222 (Biological)
Booster Cohort:- AZD1222:AZD2816
Participants, who previously received 2 doses of AZD1222 vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5*10^10 vp on Day 1.
干预措施: AZD2816 (Biological)
Booster Cohort:- mRNA:AZD1222
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD1222 5*10^10 vp on Day 1.
干预措施: AZD1222 (Biological)
Booster Cohort:- mRNA:AZD2816
Participants, who previously received 2 doses of approved mRNA based vaccine according to the authorized dose and dosing regimen, with second dose administered at least 90 days prior to study treatment, received booster dose of IM AZD2816 5*10^10 vp on Day 1.
干预措施: AZD2816 (Biological)
结局指标
主要结局
Number of Participants With Local and Systemic Solicited Treatment Emergent Adverse Events (TEAEs) in Primary Vaccination Cohort (PVC):- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816, and mRNA:AZD2816
时间窗: During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. Solicited AEs are local or systemic predefined events for assessment of reactogenicity. An e-diary was used to collect information on the timing and severity of the solicited AEs. Local AEs included pain, redness/erythema, tenderness, induration/swelling at the site of the injection. Systemic AEs included fever (\> 100 °F/37.8 °C), chills, muscle pains, fatigue, headache, malaise, nausea, and vomiting.
Number of Participants With Unsolicited TEAEs, Treatment-emergent Serious AEs (TESAEs), Medically Attended AEs (MAAEs), and Adverse Events of Special Interest (AESIs) in PVC:- AZD2816 (4), Booster Cohorts:- AZD1222:AZD2816, and mRNA:AZD2816
时间窗: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
The AEs other than solicited AEs are reported as unsolicited AEs and were collected by "open question" at study visits. AE: any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. TEAEs: events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. SAE: an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience; persistent or significant disability/incapacity; congenital anomaly. MAAE: an AE leading to a non-routine/unscheduled medically-attended visit, to or from medical doctor for any reason. AESI: an event of scientific and medical interest specific to further understanding of study drug safety profile and require close monitoring and rapid communication by investigators to Sponsor.
Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
时间窗: 28 days after second dose (Day 57)
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. Seroresponse was defined as \>= 4-fold increase in the GMT of nAb from baseline. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
Number of Participants With Abnormal Laboratory Parameters Reported as TEAEs in Primary Vaccination Cohort:- AZD2816 (4), Booster Cohorts:-AZD1222:AZD2816 and mRNA:AZD2816
时间窗: During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 [only for primary vaccination cohort])
Number of participants with abnormal laboratory parameters reported as TEAEs are reported. Laboratory tests included haematology and clinical chemistry.
Geometric Mean Titre (GMT) of SARS-CoV-2 Neutralizing Antibodies (nAb) Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)
时间窗: 28 days after second dose (Day 57)
Severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2) nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Primary Vaccination Cohort:- AZD2816 (4) with response against B.1.351 variant is the comparator group and Primary Vaccination Cohort:- AZD1222 (4) with response against the original Wuhan-Hu-1 strain is the reference group.
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control
时间窗: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- AZD1222:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control
时间窗: Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57)
Severe acute respiratory syndrome-coronavirus-2 nAb were measured by pseudoneutralisation assay. The GMT was calculated as the antilogarithm of Σ(log base 2 transformed titre/n), i.e. as the anti-logarithm transformation of the mean of the log-transformed titre, where 'n' was the number of participants with titre information. Booster Cohort:- mRNA:AZD1222 is the comparator group and AZD1222 in Historical Control is the reference group, both compared for response against the original Wuhan-Hu-1 strain.
次要结局
- Number of Participants With Local and Systemic Solicited TEAEs(During the 7-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]))
- Number of Participants With Unsolicited TEAEs, TESAEs, MAAEs, and AESIs(During the 28-day follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222(28 days after booster dose (Day 29))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222(28 days after booster dose (Day 29))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222(28 days after booster dose (Day 29))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222(28 days after booster dose (Day 29))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222(28 days after booster dose (Day 29))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816 and Booster Cohort:- AZD1222:AZD1222(28 days after booster dose (Day 29))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222(28 days after booster dose (Day 29))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816 and Booster Cohort:- mRNA:AZD1222(28 days after booster dose (Day 29))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD2816 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- Number of Participants With TESAEs, MAAEs, and AESIs From Day 1 Through 6 Months Post Last Dose(During the 6 months follow-up period after vaccination (vaccines administered on Days 1 and 29 or Day 85 [only for primary vaccination cohorts]))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4)(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4)(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD2816(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- AZD1222:AZD1222(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- AZD1222:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD2816(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- AZD1222:AZD1222(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD2816(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against the B.1.351 Variant and the Original Wuhan-Hu-1 Strain by Booster Cohort:- mRNA:AZD1222(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222 and AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and Primary Vaccination Cohort:- AZD1222 (4)(Booster Cohort: 28 days after booster dose (Day 29) and Primary Vaccination Cohort: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Booster Cohort:- mRNA:AZD1222 and the Original Wuhan-Hu-1 Strain Elicited by AZD1222 in Historical Control(Booster Cohort: 28 days after booster dose (Day 29) and Historical Control: 28 days after the second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD2816(28 days after second dose (Day 57))
- Percentage of Participants With Seroresponse of SARS-CoV-2 nAb Against B.1.351 Variant and the Original Wuhan-Hu-1 Strain Elicited by Booster Cohort:- mRNA:AZD1222(28 days after second dose (Day 57))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29(28 days after first dose (Day 29))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29(28 days after first dose (Day 29))
- GMT of SARS-CoV-2 nAb Against B.1.351 Variant Elicited by Primary Vaccination Cohort:- AZD1222 + AZD2816 (4) and the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD1222 (4) on Day 29(28 days after first dose (Day 29))
- GMT of SARS-CoV-2 nAb Against the Original Wuhan-Hu-1 Strain Elicited by Primary Vaccination Cohort:- AZD2816 (4) and Primary Vaccination Cohort:- AZD1222 (4) on Day 29(28 days after first dose (Day 29))
- GMT of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816(Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort))
- Percentage of Participants With Seroresponse of ChAdOx1 nAb in Primary Vaccination Cohorts and Following a Booster Dose of AZD2816(Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort))
- GMT of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts(Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort))
- Percentage of Participants With Seroresponse of SARS-CoV-2 Spike Protein Binding Antibodies in Primary Vaccination Cohorts and Booster Cohorts(Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort))
- Correlation Between ChAdOx1 nAb and SARS-CoV-2 nAb Titres(Booster Cohorts: 28 days after booster dose (Day 29) and Primary Vaccination Cohorts: 28 days after the second dose (Day 57 for 4-week dosing interval cohorts and Day 113 for 12-week dosing interval cohort))