Study the association between timing of the use of paracetamol during hepatitis B vaccination and the development of an antibody response in health care students who are routinely vaccinated with hepatitis B vaccine.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vaccinatierespons
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Antibody concentrations prior to and 1 month after the third vaccination
(booster vaccination) will be measured. Antibody concentrations expected to be
lower in participants that used paracetamol prophylactically. The titers in
the groups treated therapeutically with paracetamol cannot be predicted and
are subject of this study.
Secondary outcome
Alterations in the functionality of specific lymfocyte subpopulations in blood
of participants that used paracetamol prophylactically.
Background summary
Paracetamol (Acetaminophen) is an over the counter medicine and considered safe
when used according to the instruction leaflet. The 'consultatiebureau' advices
to use paracetamol as a remedy for pain and fever after vaccination in small
children. Children or adults who have experienced fever or pain after
vaccination are advised to use paracetamol prior to further vaccinations.
Recently published results indicates a negative influence on vaccination
response (lower antibody titers) in infants that were prophylactically
administered paracetamol prior to vaccination to prevent fever. It is not known
if there is an important role for timing of paracetamol in this effect on
vaccination response and if paracetamol also has this effect when used
therapeutically. It is important to gain insight into the effects of
paracetamol use during vaccination. Health organisations should have enough
information to offer a good advice about the use of paracetamol during
vaccination procedures.
Study objective
Study the association between timing of the use of paracetamol during hepatitis
B vaccination and the development of an antibody response in health care
students who are routinely vaccinated with hepatitis B vaccine.
Study design
The first month of the study is interventional, after that it will turn into an
observational study.
Intervention
There are three invervention groups that have to take paracertamol for 24 hours
(1000 mg / 8h). Timing of the paracetamol use is different: group 1 will take
paracetamol at the time of vaccination (prophylactic use), group 2 starts
taking paracetamol 6 hours after vaccination (therapeutic use 1), and group 3
starts taking paracetamol 24 hours after vacciantion (therapeutic use 2). There
is a control group that takes no paracetamol. Every participant will take
paracetamol according to one of the four groups during the first and second
hepatitis B vaccinations.
Study burden and risks
Participants who take paracetamol prophylactically or therapeutically will
probably suffer less from side effects of vaccination, such as fever and pain.
Participation to this study will significantly contribute to the scientific
knowledge, resulting in a better advice of health organizations about the use
of paracetamol during vaccination procedures.
There is a possibility that some participants could have a reduced antibody
titer at the end of the study. The antibody concentration of every participant
will be determined and evaluated, like is routinely done after hepatitis B
vaccination. An extra booster vaccination will be offered if the antibody
concentration is too low for protection against hepatitis B. This is the normal
policy and is not different for students that participate in this study and
those that do not.
The study population exists of young health care students that are routinely
vaccinated against hepatitis B. In the vaccination protocol a blood sample is
routinely taken 1 month after the third vaccination and for this study we will
draw 14 mL. of extra blood. An extra blood sample (14 ml.) will be taken
specifically for this study prior to the third vaccination. Antibody titers
and functionality of lymphocyte subpopulations will be determined in the blood.
PO Box 1
3720 BA Bilthoven
Nederland
PO Box 1
3720 BA Bilthoven
Nederland
Listed location countries
Age
Inclusion criteria
- Good health.
- Able to perform the study according to the procedures.
- Informed consent present.
Exclusion criteria
- History of acute or chronic hepatitis B
- Earlier hepatitis B vaccination
- Evidence of a serious disease, that needs immunosuppresive treatment.
- A known primary or secondary immunodeficiency
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 | EUCTR2011-000923-33-NL |
| CCMO | NL35901.000.11 |