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临床试验/NCT05715944
NCT05715944已完成3 期

Open-Label, Single-Arm, Phase 3b Study of the Incidence of Severe COVID-19 and Adverse Events Following AZD1222 COVID-19 Vaccination in Botswana Against SARS-CoV-2, AZD1222 - ESR-21-21311

Botswana Harvard AIDS Institute Partnership1 个研究点 分布在 1 个国家目标入组 10,888 人开始时间: 2021年9月15日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
10,888
试验地点
1
主要终点
Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222,
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The AstraZeneca Study is a single-arm, open-label, interventional, Phase 3b study to determine the incidence of laboratory-confirmed COVID-19 hospitalizations, disease severity, and deaths and attributable adverse events (AEs) in participants in Botswana given 1 to 2 injections of AZD1222 eight to twelve weeks apart as primary series and/or 1 injection as booster dose. Length of follow-up will be 6 to 12 months, depending upon at which dose a participant is enrolled.

详细描述

The AstraZeneca Study is an Open-Label, Single-Arm, Phase 3b Study of the incidence of severe COVID-19 and adverse events following AZD1222 COVID-19 vaccination in Botswana against SARS-CoV-2. The study enrolled adult participants >18 years (previously >40 years) in Botswana and vaccinate them with 1 to 2 doses of AZD 1222, as primary series and/or 1 dose as booster.

Primary Objectives:

  1. To assess the occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses.
  2. To assess AEs among individuals vaccinated with at least one dose of AZD1222.

Secondary Objectives:

  1. To assess the occurrence of COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses by age group, co-morbidity group, the severity of disease and the time since the last dose.
  2. To estimate the incidence of symptomatic SARS-CoV-2 infections in a sub-cohort of study participants among individuals vaccinated with at least one dose of AZD1222 by number of vaccine doses

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
是

入选标准

  • •Participants are eligible to be included in the study only if all of the following criteria apply:
  • •Type of Participant
  • •Participants who have willingness and ability to comply with study requirements/procedures (if applicable, with assistance by legally authorised representative) based on the assessment of the investigator.
  • •Participants who have not yet received 3 doses of COVID-19 vaccine (2 as primary series and a booster dose). Persons who have received no prior vaccination are eligible to enroll at Day 0 to start a primary series. Persons who have received a single dose of COVID-19 vaccine at least 8 week prior (note that this includes persons who have received a single dose of Johnson & Johnson vaccine) are eligible to enroll at Day 70 to complete their primary series and receive a booster dose 3 months thereafter. Persons who have received a primary series of COVID-19 vaccine at least 3 months prior are eligible to enroll at Day 170 to receive a booster.
  • •Informed Consent
  • •Capable of giving signed informed consent, as described in Appendix A, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
  • •Note: A separate informed consent will be used for optional sample collection.
  • •Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses.
  • •Participant must be ≥ 18years of age at the time of signing the informed consent and residing in the catchment area of select hospitals in Botswana.

排除标准

  • •Participants are excluded from the study if any of the following criteria apply:
  • •Prior/Concomitant Therapy
  • •Receipt of, or planned receipt of a COVID-19 vaccine booster dose, or any medications or investigational products indicated for the prevention of SARS-CoV-2 infection or treatment of COVID-
  • •Note: For study participants who become hospitalised with COVID-19, receipt of licensed treatment options and/or participation in investigational treatment studies is permitted.
  • •Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines within 30 days prior to and after administration of study intervention (i.e. the first, second and booster doses). Outside these periods, other routine vaccinations are permitted as clinically indicated.
  • •Medical Conditions
  • •Hypersensitivity to the active substance or to any of the excipients listed in Section 6.
  • •The participant reports being pregnant or nursing or has a positive pregnancy test at the time of enrolment or is planning on becoming pregnant within 6 months (for those enrolled at primary series dose 1) or 3 months (for those enrolled at primary series dose 2) of the first vaccination in the study.
  • •Additional details are described in Section 5.2.
  • •Individuals with risk factors for or reported history of thrombosis and/or thrombocytopenia.
  • •Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder) or prior history of significant bleeding or bruising following intramuscular injections or venepuncture.
  • •History of Guillain-Barré syndrome.
  • •Any confirmed or suspected immunosuppressive or immunodeficient state, including Asplenia.
  • •Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness, as judged by the investigator (mild/moderate well-controlled comorbidities are allowed).
  • •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.
  • •Note: The AESIs as outlined in the CSP should be considered when evaluating a participant for this Exclusion Criteria as the presence of these AESIs, especially if untreated or uncontrolled, may be a safety risk to the participant, affect the ability of the participant to participate in the study, or impair interpretation of the study data.
  • •Other Criteria
  • •Current participation in any other research studies that would interfere with the objectives of this study. The determination of whether participation in another study would be exclusionary for a given participant will be made by the investigator/designee.

研究组 & 干预措施

AZD 1222

Experimental

AZD1222 vaccine

Dose Formulation:

10 mM histidine, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6

Current/Former names/alias(es):ChAdOx1 nCoV-19

干预措施: AZD 1222 (Drug)

结局指标

主要结局

Occurrence of severe COVID-19 disease among individuals vaccinated with AZD1222,

时间窗: From at least 15 days after the second or booster dose up to 12 months following the first vaccination dose

Occurrence of hospitalizations and deaths due to laboratory-confirmed SARS CoV 2 infection

Occurrence of Adverse Events among individuals vaccinated with at least one dose AZD1222

时间窗: Up to 12 months following the first vaccination dose

Occurrence of Serious Adverse Events and Adverse Events of Special Interest up to 12 months following the first vaccination dose

次要结局

  • Occurrence of COVID-19 disease among individuals vaccinated with AZD1222 by number of vaccine doses and vaccine exposure, by age group, comorbidity group, severity of disease, and the time since the last dose(From at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose,)
  • Incidence of symptomatic SARS-CoV-2 infections in a sub-cohort of study participants among individuals vaccinated with at least one dose of AZD1222, by number of vaccine doses, and by vaccine exposure(From at least 22 days after the first dose / at least 15 days after the second or booster dose, up to 12 months following the first vaccination dose)

研究者

发起方
Botswana Harvard AIDS Institute Partnership
申办方类型
Other
责任方
Principal Investigator
主要研究者

Joseph M Makhema

Principal Investigator

Botswana Harvard AIDS Institute Partnership

研究点 (1)

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