PDF(Pubmed)
Abstract：
BACKGROUND: Immunocompromised hosts (ICH) experience more breakthrough infections and worse clinical outcomes following infection with COVID-19 than immunocompetent people. Prophylactic monoclonal antibody therapies can be challenging to access, and escape variants emerge rapidly. Immunity conferred through vaccination remains a central prevention strategy for COVID-19. COVID-19 vaccines do not elicit optimal immunity in ICH but boosting, through additional doses of vaccine improves humoral and cellular immune responses. This trial aims to assess the immunogenicity and safety of different COVID-19 vaccine booster strategies against SARS-CoV-2 for ICH in Australia.
METHODS: Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC) is an adaptive randomised trial of one or two additional doses of COVID-19 vaccines 3 months apart in people living with HIV, solid organ transplant (SOT) recipients, or those who have haematological malignancies (chronic lymphocytic leukaemia, non-Hodgkin lymphoma or multiple myeloma). Key eligibility criteria include having received 3 to 7 doses of Australian Therapeutic Goods Administration (TGA)-approved COVID-19 vaccines at least 3 months earlier, and having not received SARS-CoV-2-specific monoclonal antibodies in the 3 months prior to receiving the study vaccine. The primary outcome is the geometric mean concentration of anti-spike SARS-CoV-2 immunoglobulin G (IgG) 28 days after the final dose of the study vaccine. Key secondary outcomes include anti-spike SARS-CoV-2 IgG titres and the proportion of people seroconverting 6 and 12 months after study vaccines, local and systemic reactions in the 7 days after vaccination, adverse events of special interest, COVID-19 infection, mortality and quality of life.
CONCLUSIONS: This study will enhance the understanding of COVID-19 vaccine responses in ICH, and enable the development of safe, and optimised vaccine schedules in people with HIV, SOT, or haematological malignancy.
BACKGROUND: ClinicalTrials.gov NCT05556720. Registered on 23rd August 2022.
METHODS: Bringing optimised COVID-19 vaccine schedules to immunocompromised populations (BOOST-IC) is an adaptive randomised trial of one or two additional doses of COVID-19 vaccines 3 months apart in people living with HIV, solid organ transplant (SOT) recipients, or those who have haematological malignancies (chronic lymphocytic leukaemia, non-Hodgkin lymphoma or multiple myeloma). Key eligibility criteria include having received 3 to 7 doses of Australian Therapeutic Goods Administration (TGA)-approved COVID-19 vaccines at least 3 months earlier, and having not received SARS-CoV-2-specific monoclonal antibodies in the 3 months prior to receiving the study vaccine. The primary outcome is the geometric mean concentration of anti-spike SARS-CoV-2 immunoglobulin G (IgG) 28 days after the final dose of the study vaccine. Key secondary outcomes include anti-spike SARS-CoV-2 IgG titres and the proportion of people seroconverting 6 and 12 months after study vaccines, local and systemic reactions in the 7 days after vaccination, adverse events of special interest, COVID-19 infection, mortality and quality of life.
CONCLUSIONS: This study will enhance the understanding of COVID-19 vaccine responses in ICH, and enable the development of safe, and optimised vaccine schedules in people with HIV, SOT, or haematological malignancy.
BACKGROUND: ClinicalTrials.gov NCT05556720. Registered on 23rd August 2022.
摘要：
背景：与有免疫能力的人相比，免疫功能低下的宿主（ICH）在感染COVID-19后经历更多的突破性感染和更差的临床结果。预防性单克隆抗体疗法可能具有挑战性，逃逸变体迅速出现。通过疫苗接种赋予的免疫力仍然是COVID-19的中心预防策略。COVID-19疫苗不会在ICH中引发最佳免疫力，但会增强免疫力，通过额外剂量的疫苗改善体液和细胞免疫反应。该试验旨在评估澳大利亚针对ICH的SARS-CoV-2的不同COVID-19疫苗加强策略的免疫原性和安全性。
方法：将优化的COVID-19疫苗接种方案引入免疫功能低下人群（BOOST-IC）是一项适应性随机试验，在艾滋病毒感染者中间隔3个月增加一或两剂COVID-19疫苗，实体器官移植（SOT）受者，或患有血液恶性肿瘤（慢性淋巴细胞白血病，非霍奇金淋巴瘤或多发性骨髓瘤）。关键的资格标准包括至少3个月前接受过3至7剂澳大利亚治疗用品管理局(TGA)批准的COVID-19疫苗，并且在接受研究疫苗之前的3个月内没有接受过SARS-CoV-2特异性单克隆抗体。主要结果是在最终剂量的研究疫苗后28天，抗尖峰SARS-CoV-2免疫球蛋白G（IgG）的几何平均浓度。关键的次要结果包括抗峰值SARS-CoV-2IgG滴度以及研究疫苗后6个月和12个月血清转换的人群比例，疫苗接种后7天内的局部和全身反应，特别关注的不良事件，COVID-19感染，死亡率和生活质量。
结论：这项研究将增进对ICH中COVID-19疫苗反应的了解，并使安全的发展，优化了艾滋病毒感染者的疫苗接种计划，SOT,或血液恶性肿瘤。
背景：ClinicalTrials.govNCT05556720。2022年8月23日注册。
方法：将优化的COVID-19疫苗接种方案引入免疫功能低下人群（BOOST-IC）是一项适应性随机试验，在艾滋病毒感染者中间隔3个月增加一或两剂COVID-19疫苗，实体器官移植（SOT）受者，或患有血液恶性肿瘤（慢性淋巴细胞白血病，非霍奇金淋巴瘤或多发性骨髓瘤）。关键的资格标准包括至少3个月前接受过3至7剂澳大利亚治疗用品管理局(TGA)批准的COVID-19疫苗，并且在接受研究疫苗之前的3个月内没有接受过SARS-CoV-2特异性单克隆抗体。主要结果是在最终剂量的研究疫苗后28天，抗尖峰SARS-CoV-2免疫球蛋白G（IgG）的几何平均浓度。关键的次要结果包括抗峰值SARS-CoV-2IgG滴度以及研究疫苗后6个月和12个月血清转换的人群比例，疫苗接种后7天内的局部和全身反应，特别关注的不良事件，COVID-19感染，死亡率和生活质量。
结论：这项研究将增进对ICH中COVID-19疫苗反应的了解，并使安全的发展，优化了艾滋病毒感染者的疫苗接种计划，SOT,或血液恶性肿瘤。
背景：ClinicalTrials.govNCT05556720。2022年8月23日注册。
