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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Known hypersensitivity to influenza vaccine or egg proteins;

Previous influenza vaccination for the current season;

Current infection;

Current acute illness;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vaccine injection

    Other intervention

    Injection of the vaccine in chronic renal insufficiency patients.

Treatment groups

735 Participants
are divided into 2 treatment groups
Group A: Morning injectionActive comparator 1 intervention
Group B: Evening injectionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Antibody titers (seroconversion) at 4 weeks after injection of inactivated influenza vaccine in each arm.

Seroconversion will be defined as an increase in antibody titer of at least 4-fold (≥4) over pre-vaccination titer AND an antibody titer ≥ 1:40 (seroprotection) four weeks post-vaccination, for at least one of the three vaccine antigens.

Time frame
7 months

Secondary outcomes

1

Number of seasonal influenza virus infections in each arm at 4 weeks

Comparing the number of seasonal influenza virus infections in each arm between a group of patients vaccinated in the morning and a group vaccinated in the evening at 4 weeks. The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.

Time frame
7 months
2

Number of seasonal influenza virus infections in patients with chronic renal insufficiency at 6 months

Comparing the number of seasonal influenza virus infections in patients with chronic renal failure between a group of patients vaccinated in the morning and a group vaccinated in the evening in the 6 months following vaccination. The occurrence of influenza, as confirmed by a PCR test, will be noted in the follow-up consultation.

Time frame
12 months
3

Antibody titers reacting in each arm

In patients with chronic renal failure, compare the evolution of antibody titres reacting with vaccine antigens 4 weeks after influenza vaccination between a group of patients vaccinated in the morning and a group of patients vaccinated in the evening. The titer of antibodies reacting with vaccine antigens is measured by ELISA ;

Time frame
7 months
4

Number of anti-vaccine antibodies inhibiting hemmagglutination

4 weeks after influenza vaccine injection, compare hemmagglutination-inhibiting anti-vaccine antibody titer in CKD patients vaccinated in the morning and evening. The titer of hemagglutination-inhibiting anti-vaccine antibodies will be determined by hemagglutination inhibition test

Time frame
7 months

Other outcomes

Sponsors and contacts

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