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Vaccinations in the Immunocompromised population: paramount and paradox.

Recruiting
Conditions
Immunocompromising conditions
impaired immune system
10021879
10027665
Registration Number
NL-OMON56421
Lead Sponsor
Academisch Medisch Centrum
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
Not specified
Target Recruitment
980
Inclusion Criteria

Patient group:
- Indication for rabies/hepatitis A and/or or pneumococcal vaccination
- Age 18-70 years old;
- At least of the following criteria
1. Diagnosed with HIV; and/or
2. Treated with one or more immunosuppressive agents for underlying
disease/organ transplant; and/or
3. Hematopoietic stem cell transplant (HSCT) recipients 3-24 months after HSCT.
- Able and willing to consent
Control group:
- Immunocompetent individuals aged 18-70 years.
- Indication for hepatitis A and/or or pneumococcal vaccination
- Able and willing to consent.

Exclusion Criteria

Diagnosis of one of the following
1. Primary immune deficiency disorder
2. Active malignancy
3. Hemophilic disorder precluding intramuscular vaccination.
4. Functional asplenia
- Receiving chemotherapy
- An allergy to any of the components of the hepatitis A or pneumococcal
vaccines.
- Naturally acquired hepatitis A immunity (either assessed in the medical
history or at first antibody concentration measurement)
- Previous vaccination with any pneumococcal conjugate vaccine
- Previous vaccination with Pneumovax 23 <5 years before enrollment.
- Age <18 years or >70 years
- Donor lymfocyte infusion < 28 days
- Pregnancy
- No indication for hepatitis A/pneumococcal vaccination
- In ICPs only: Steroids < 10 mg prednisolone or its equivalent as only
immunosuppressant (low dose corticosteroids).
- Not being able or willing to consent
- Previous vaccination against rabies

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The proportion of ICPs and controls with protective antibody titers<br /><br>(seroconversion rate) after rabiës/hepatitis A/pneumococcal vaccination.</p><br>
Secondary Outcome Measures
NameTimeMethod
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