Vaccinations in the Immunocompromised population: paramount and paradox.
- Conditions
- Immunocompromising conditionsimpaired immune system1002187910027665
- 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
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.
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
Name Time Method <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
Name Time Method