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临床试验/TCTR20240708002
TCTR20240708002已完成不适用

Antibody Response in People living with HIV Comparing CD4 T-cell Levels more than 200 vs. lower or equal 200 cells/mm3 after mRNA COVID-19 Vaccine Booster

Thai AIDS society0 个研究点目标入组 74 人开始时间: 2024年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
74

研究概览

简要总结

In low CD4 group, participants exhibited lower baseline levels of both Anti RBD Ig and sVNT against all variants. In post-booster vaccination with the bivalent COVID-19 vaccine, the lower CD4 group also showed reduced immunogenicity. Higher GMR was observed in low CD4 group

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 N/A (No limit)(—)
性别
All

入选标准

  • 1. Individuals living with HIV aged 18 years and above
  • 2. on stable antiretroviral regimen for at least three months
  • 3. Received at least two doses of the primary COVID-19 vaccine more than three months prior to enrollment in the study

排除标准

  • 1. virologic failure, defined as an HIV viral load exceeding 200 copies/mL
  • 2. high-level immunosuppression, such as the use of prednisolone at doses exceeding 20 mg/day
  • methotrexate at doses exceeding 0.4 mg/kg/week, or previous administration of rituximab or TNF-alpha blockers within the past year
  • 3. active autoimmune disease
  • 4. contraindications for COVID-19 vaccination
  • 5. previous administration of monoclonal antibodies, JAK inhibitors, or convalescent plasma for COVID-19
  • 6. receipt of any other vaccination within 15 days prior to enrollment
  • 7. self-reported history of SARS-CoV-2 infection in the 3 months prior to enrollment.

研究者

发起方
Thai AIDS society

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