To gain insight in speed of onset and levels of antibody titers ("boostability") after a completed intradermal pre-exposure rabies immunization.
ID
Source
Brief title
Condition
- Viral infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The percentage of participants with a titer of * 0.5 IU/ml at day 7
The percentage of participants with a titer of * 0.5 IU/ml at day 14
Secondary outcome
The percentage of participants with a titer of * 0.5 IU/ml at day 0
The percentage of participants with a titer of * 3.0 IU/ml at day 7
The percentage of participants with a titer of * 3.0 IU/ml at day 14
Background summary
Rabies is a neglected disease with a case-fatality rate of almost 100% in
humans who develop symptoms. Human rabies causes more than 55.000 deaths
annually worldwide. In 99% of human rabies, transmission is due to the bite of
a rabies-infected dog. Rabies is fully preventable by prompt wound care, and
the availability of vaccines and human anti-rabies immunoglobulin (HRIG). In
the past 10 years, three fatal cases of rabies occurred in The Netherlands, all
in the AMC. The disease can be prevented by pre-exposure prophylaxis (PrEP).
This prophylaxis, consisting of three immunizations on Days 0, 7 and 21-28, is
highly recommended for those at risk, like military personnel.
Little is known about the quantitative immune response directly after
post-exposure immunization. This immune response to PEP is referred to as
*boostability* in literature.
Although studies show positive results on boostability on Days 14 and 28 after
booster immunization, data on antibody response directly after booster
immunization are scarce.
In this study, we are primarily interested in the rabies antibody concentration
during the first weeks after intradermal immunization, reflecting the
immunological memory.
The study set out to explore the hypothesis that a rapid antibody response is
initiated after booster immunization, resulting in protective antibody levels
within a week.
Study objective
To gain insight in speed of onset and levels of antibody titers
("boostability") after a completed intradermal pre-exposure rabies
immunization.
Study design
Observational cohort study
Study burden and risks
There are no direct benefits for the military personnel. The risk for the
military personnel is minimal, the only interventions are three vena punctures.
Meibergdreef 9
Amsterdam 1100DD
NL
Meibergdreef 9
Amsterdam 1100DD
NL
Listed location countries
Age
Inclusion criteria
Healthy military volunteers that received a completed intradermal immunization last year or 2 years ago.
Exclusion criteria
- Age < 18 years;
- No previous booster immunization;
- No previous post-exposition treatment with HRIG;
- Potential deployment to rabies endemic area within study period ;
- Presence of a serious medical history with a potential effect on the immune system such
as diabetes mellitus, HIV, functional or hyposplenia/asplenia;
- Allergies to one of the components of the rabies vaccine such as chicken egg protein,
polygeline, hypersensitivity to neomycin, chlortetracycline, amphotericin B and other
antibiotics of the same class;
- Use of mefloquine or chloroquine during the study period ;
- Pregnancy ;
- Breastfeeding;
- Immune compromised due to medication such as prednisolone, TNF-alfa inhibitors,
*biologicals* or immunodeficiency due to humoral or cellular cause.
Design
Recruitment
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 |
|---|---|
| CCMO | NL59466.018.16 |