Response to hepatitis A and B vaccine among children with immunesuppression due to either hiv or immunesuppressive medicatio

Phase 4

Completed

Conditions: jaundice
Viral hepatitis
10027665
10047438

Registration Number: NL-OMON38280

Lead Sponsor: Geneeskundige en Gezondheidsdienst (GGD) Amsterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 250

Inclusion Criteria

All children from 1 up to and including 15 years of age, known with:
- hiv-infection irrespective of treatment status. The most recent tested CD4 T cell percentage should be 15% or higher (group 1); OR:
- juvenile idiopathic arthritis, for which one or more of the following treatments is used (orally or systemically) for at least 3 months: Prednis(ol)on >= 0.25 mg/ kg body weight, or another corticosteroid in equivalent dosage; Etanercept (Enbrel®); Infliximab (Remicade®); Methotrexaat (Emthexate® or Metoject®) (group 2)
are eligible for inclusion.

Exclusion Criteria

Not eligible for inclusion are:
- children who have received one or more vaccinations against hepatitis A and hepatitis B before;
- children who have been infected with hepatitis A and hepatitis B (serologically proven);
- children who received immunoglobulins within 6 months prior to study entrance.
- children known with a blood clotting disorder which prohibits intramuscular administration of the vaccine.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentages of children with hiv or use of immunesuppressive medication who<br /><br>seroconverted for hepatitis A (anti-hepatitis A virus IgG antibodies) and<br /><br>hepatitis B (anti-hepatitis B surface antigen IgG antibodies): 4-6 weeks after<br /><br>the first vaccination, prior to the second vaccination, and 4-6 weeks after the<br /><br>second vaccination. Also of interest are the geometric mean titres (GMT) per<br /><br>group, at aforementioned time points.<br /><br>These will be compared with seroconversion percentages and GMT of<br /><br>non-immune-suppressed children (already known from previously performed<br /><br>studies).</p><br>

Secondary Outcome Measures