The effectiveness of Ambirix will be investigated in 2 groups: 1) children with hiv-infection, with CD4 counts > 15% 2) children with a rheumatic disease for which immune-suppressive medication is used. MedDRA version: 9.1 Level: LLT Classification code 10002725 Term: Anti-HIV positive MedDRA version: 9.1 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis
Conditions
Interventions
Trade Name: Ambirix
Pharmaceutical Form: Suspension for injection
Sponsors
Public Health Service Amsterdam
Eligibility
Sex/Gender
All
Inclusion criteria
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): 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range ;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): 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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Not eligible for inclusion are: - children who have received one or more vaccinations against hepatitis A and/ or hepatitis B before; - children who have been infected with hepatitis A and/ or 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. ;Exclusion criteria: Not eligible for inclusion are: - children who have received one or more vaccinations against hepatitis A and/ or hepatitis B before; - children who have been infected with hepatitis A and/ or 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: How effective is combined vaccination against hepatitis A and B in hiv-infected children and in children using immune-suppressive medication for juvenile idiopathic arthritis?;Secondary Objective: Is the degree of immunesuppression related/ associated with the response to vaccination? Markers for degree of immunesuppression are: for hiv-infected children: CD4-cell count and viral load for children using immune-suppressive medication for JIA: dosage and duration of use of the immunesuppressive medication.;Primary end point(s): Primary end points of this study are: - the percentages of children with hiv or use of immunesuppressive medication who seroconverted for hepatitis A (anti-hepatitis A virus IgG antibodies, anti-HAV-IgG) and hepatitis B (anti-hepatitis B surface antigen IgG antibodies, anti-HBs-IgG): 4-6 weeks after the first vaccination, prior to the second vaccination, and 4-6 weeks after the second vaccination. For hepatitis A, seroconversion is defined as: more than 30 IU/L anti-HAV-IgG. For hepatitis B, seroconversion is defined as: more than 10 IU/L anti-HBs IgG. - the geometric mean titre (GMT) per group, at aforementioned time points. These will be compared with seroconversionpercentages and GMT of non-immune-suppressed children (already known from previously performed studies). ;Main Objective: How effective is combined vaccination against hepatitis A and B in hiv-infected children and in children using immune-suppressive medication for juvenile idiopathic arthritis?;Secondary Objective: Is the degree of immunesuppression related/ associated with the response to vaccination? Markers for degree of immunesuppression are: for hiv-infected children: CD4-cell count and viral load for children using immune-suppressive medication for JIA: dosage and duration of use of the immunesuppressive medication.;Primary end point(s): Primary end points of this study are: - the percentages of children with hiv or use of immunesuppressive medication | — |
Countries
Netherlands
Contacts
Public Contact; ;
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Outcome results
None listed