Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure

Официальное название

Study of the Impact of Time of Vaccination on Response to Influenza Vaccine in Patients With Chronic Renal Failure - CHRONOVAX 2

Обзор

Immune response to influenza vaccine in patients with chronic renal insufficiency.

Подробное описание

Seasonal influenza vaccination is recommended for patients with chronic renal insufficiency, as influenza is responsible for significant morbidity and mortality in this immunocompromised population. However, the immune response to this vaccination is limited in this population.

There are currently no recommendations concerning the timing of influenza vaccine in the general population or in immunocompromised patients.

In this context, recent studies have shown that the time of vaccination can have an impact on vaccine efficacy. This is the case for BCG, influenza and COVID vaccinations.

On this basis, our main hypothesis is that the administration of influenza vaccine to patients with chronic kidney failure is more effective in the morning than in the evening.

Вмешательства

• Другое Vaccine injection
  Injection of the vaccine in chronic renal insufficiency patients.

Первичные конечные точки

• Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm. [Срок оценки: 7 months]

Вторичные конечные точки (5)

• Number of seasonal influenza virus infections in each arm at 4 weeks [Срок оценки: 7 months]
• Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months [Срок оценки: 12 months]
• Antibody titers reacting in each arm [Срок оценки: 7 months]
• Number of anti-vaccine antibodies inhibiting hemmagglutination [Срок оценки: 7 months]
• Number of neutralizing anti-vaccine antibodies [Срок оценки: 7 months]

Критерии участия

Критерии включения

• Chronic renal failure patient at stage 4 or 5 (i.e. estimated GFR < 30mL/min/1.73m2); or Dialysis patient; or renal transplant patient regardless of GFR;
• Age ≥ 18 years;
• Indication for influenza vaccination;
• Express free and informed consent.

Критерии исключения

• Known hypersensitivity to influenza vaccine or egg proteins;
• Previous influenza vaccination for the current season;
• Current infection;
• Current acute illness;
• Treatments with a major impact on vaccine response:
• Treatment of rejection within the previous 3 months;
• Renal transplantation with induction performed within the previous 6 months;
• Immunosuppressive treatment including CTLA4 agonist, complement inhibitor, anti-CD20;
• Treatments that may distort the serological response: Polyvalent immunoglobulin infusion within the preceding 3 months;
• Vulnerable persons (minors, adults under guardianship or trusteeship, persons deprived of their liberty, persons unable to speak French);
• Subjects not affiliated to Social Security.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Франция · 1 центр

• CHU Nice - Hôpital Pasteur 2 — Nice

Идентификаторы

NCT: NCT06907667 · 23-API-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗