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临床试验/NCT06271681
NCT06271681尚未招募4 期

Evaluation of PCV21 Vaccination Among PPSV23-experienced, Immunocompromised Elderly Veterans

VA Sierra Nevada Health Care System0 个研究点目标入组 45 人开始时间: 2026年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
尚未招募
入组人数
45
主要终点
Change in opsonophagocytic assay (OPA) geometric mean titers (GMT)

研究概览

简要总结

The investigators will evaluate the immune response of immunocompromised adults, who have previously received at least 1 dose of 23-valent pneumococcal polysaccharide vaccine, to the booster with of 21-valent pneumococcal conjugate vaccine . Immune response will be assessed by opsonophagocytic assay reactivity.

详细描述

Recommendations for optimal vaccination strategies in immunocompromised patients has been limited. Strategies focused on utilizing a conjugate vaccine alone, as either initial vaccination or booster dosing, have not demonstrated significant increased antibody expression in immunocompromised patients[7]. Strategies where immunocompromised patients were vaccinated with a conjugate vaccine followed by polysaccharide vaccine have demonstrated that 50% of individuals achieve functional antibodies[7]. Since improved antibody response in naive patients has been seen in combination vaccination, we aim to test this strategy for boosting in previously vaccinated immunocompromised patients. The 15 valent Pneumococcal Conjugate Vaccine (PCV15) is available for use in adults and contains S. Pneumoniae serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F [5].

In this study we postulate that booster dosing with PCV21 in immunocompromised adults who are at least 5 years from receipt of PPSV23 will elicit a strong immune response represented by change in serotype specific OPA GMT from baseline to 4 weeks post booster vaccine completion. We will specifically evaluate the change in pneumococcal opsonophagocytic activity at baseline to 6 months (Pn-OPA) for S. Pneumoniae serotypes 3, 6A, 15A, 19A, 20A, 23A, 31, 35B, 9n, 11A, and 22F. These specific serotypes have been selected due to current disease burden trends, to address current gaps in data, and have been identified as the most relevant for PCV development underway.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Subject meets the CDC definition of an immunocompromising condition
  • o chronic renal failure, congenital or acquired asplenia, generalized malignancy, HIV infection, Hodgkin disease, iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, sickle cell disease or other hemoglobinopathies, and solid organ transplant.
  • Have received at least 1 dose of PPSV23

排除标准

  • Less than 5 years since last receipt of PPSV23 validated to patient medical record and Immunize Nevada Website
  • Previous administration of PCV20
  • Previous administration of PCV13
  • Previous administration of PCV15
  • Less than 14 days since administration of any COVID19 vaccination
  • Previous history of Invasive Pneumococcal Disease (IPD)
  • Antibiotic treatment within the previous 90 days

研究组 & 干预措施

All participants

Other

This will be a single population open label trial evaluating immune response to PCV21 in subjects with immunocompromising conditions or receiving immunosuppressive medications.

干预措施: 21-valent pneumococcal conjugate vaccine (Drug)

结局指标

主要结局

Change in opsonophagocytic assay (OPA) geometric mean titers (GMT)

时间窗: 24 months

Evaluation of the change fold increase in S. Pneumonia OPA GMT from baseline to 24 weeks after the administration of a pneumococcal vaccine booster series consisting of PCV15 followed by PPSV23 8 weeks later for S. Pneumoniae serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Principal Investigator
主要研究者

Amneet Rai

Associate Chief of Pharmacy for Informatics, Education, Health Outcomes, and Research

VA Sierra Nevada Health Care System

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