To protect children with hiv and children using immune-suppressive medication against hepatitis A and B, and to determine the immunogenicity of the combined hepatitis A and B vaccine in these children.
Source
Brief title
Condition
- Immune disorders NEC
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentages of children with hiv or use of immunesuppressive medication who
seroconverted for hepatitis A (anti-hepatitis A virus IgG antibodies) and
hepatitis B (anti-hepatitis B surface antigen IgG antibodies): 4-6 weeks after
the first vaccination, prior to the second vaccination, and 4-6 weeks after the
second vaccination. Also of interest are the geometric mean titres (GMT) per
group, at aforementioned time points.
These will be compared with seroconversion percentages and GMT of
non-immune-suppressed children (already known from previously performed
studies).
Secondary outcome
Anti-HAV-IgG and anti-HBs seroconversionrates and their relation to the degree
of immunesuppression, age, gender, and ethnicity.
Background summary
There is hardly any data on the immunogenicity of the hepatitis A and B vaccine
in children with immunesuppression due to either hiv or immunesuppressive
medication. On the other hand, the number of children being exposed to
hepatitis A and/ or hepatitis B virus is on the rise, since travel to hepatitis
A and/ or B endemic countries has increased over the last decades. In order to
protect these children properly, it is important to know how effective the
vaccine against hepatitis A and B is among these immune suppressed children. It
is generally assumed, that antibody response after hepatitis A and B
vaccination in immune-suppressed children is less than in healthy children.
Study objective
To protect children with hiv and children using immune-suppressive medication
against hepatitis A and B, and to determine the immunogenicity of the combined
hepatitis A and B vaccine in these children.
Study design
Phase IV interventional research design, without a placebo group.
Intervention
Participants will receive the combined (inactivated) hepatitis A and (rDNA)
hepatitis B vaccine Ambirix® twice: once at the time of inclusion and once
26-30 weeks thereafter.
Study burden and risks
Blood for serotesting will be drawn 4 times: before inclusion, and 4, 26 and 30
weeks after the first vaccination. Blood drawing for research purposes will be
combined with blood drawing for medical purposes whenever possible.
The burden of blood drawing includes mild local pain. Associated risks are
rare, mild and of short duration. The burden of the 2 vaccinations includes
short-lasting, local pain. Side effects of vaccination are mild and
self-limiting. Fever and allergic reactions are rare or even very rare.
There are 4 research appointments, each lasting 5-10 minutes, and following the
regular medical check-up at the oupatient clinic, whenever possible.
For the investigation of the study objective, partipation of children is
needed, since data from vaccine research among immune-suppressed adults are not
applicable to children. Moreover, the vaccination schedule for children differs
from that for adults.
Besides, vaccination may benefit the child, in particular, when one considers
that chances of (travel-related) exposure to hepatitis A and/ or hepatitis B
virus have increased.
Nieuwe Achtergracht 100
1018 WT Amsterdam
NL
Nieuwe Achtergracht 100
1018 WT Amsterdam
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2008-003280-40-NL |
CCMO | NL23065.000.09 |