This study has two goals:1. Investigate the cellular and humoral immune response of immune compromised travellers compared to the healthy traveller.2. Investigate the epidemiology of travel related infectious diseases in a population of dutch…
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The antibody titer after vaccination of immune compromised patients compared to
immunocompetent patients and the incidence of infectious diseases during travel
Secondary outcome
1a The capability of naïve memory B cells to generate an
antibody response after live, conjugated and polysaccharide vaccine dose
increase in case of non-responders
1b Dendritic cell function and antigen presentation properties
1c CD8+ cytotoxic properties
1d Waning effects of vaccines by the presence of a prolonged (i.e. after 6
months) qualitative antibody response by detecting high affinitive IgG
antibodies in serum as well as B-cell reactivation properties
Background summary
Individuals with immune deficiencies are at increased risk for infectious
diseases compared to general population. In addition, the responsiveness after
immunization can be diminished due to impaired function of monocytes, B cells
and/or T cells as well as other co-morbidity and the use of certain
immunosuppressive drugs . Exposure to infectious pathogens sharply increases
during travel, especially if people travel to tropical destinations. The aim of
this study is to investigate the cellular and humoral immune response after
vaccination of the immunecompromised host and to investigate travel related
infections in general.
Study objective
This study has two goals:
1. Investigate the cellular and humoral immune response of immune compromised
travellers compared to the healthy traveller.
2. Investigate the epidemiology of travel related infectious diseases in a
population of dutch travellers
Study design
This will be a longitudinal observational cohort study. Potential candidates
will receive a letter at least one week prior to their visit to the travel
clinic containing information about the study and a patient information
document. Questions about the study can be asked during the first visit.
Inclusion to the study will only take place after signing the informed consent
document. Thereafter, the participant is asked to donate two peripheral blood
samples of 5 ml at three of four time points in this study as well as one
urinal and one fecal sample at two time points if patients travel to a
destination outside Europe or the United States/Canada (moments can overlap).
In addition, persons are asked to keep a diary during their travel, noting only
possible infectious events (fever, illness, contact with ill persons).
Participation in the study is terminated when all samples are collected or when
the patient decides to opt out. In practice, participation will not exceed the
duration of 12 months.
Blood samples:
1 Before vaccination (null serum).
2 Four weeks after vaccination (optimal time interval to measure immune
response) or after return from travel (to measure seroconversion to certain
infections, depending on the travel history).
4 After 9-12 months (to assess waning of the immune response).
Urine and fecal samples:
1 Prior to travel.
2 After returning from travel.
Study burden and risks
Study participants will donate 10 ml of blood at three visits to the travel
clinic. In case of a trip outside Western Europe, participants will be asked to
a collect a faecal and urinal sample before and after their journey. In
addition, study participants will be asked to keep a diary during their trip to
assess the rate of possible exposure to infectious pathogens.
Dr. Molewaterplein 40
Rotterdam 3000 CA
NL
Dr. Molewaterplein 40
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
All individuals, irrespective of age, sex and underlying illness visiting the Erasmus MC *vaccination and travel clinic* requiring travel related, medically indicated or voluntary vaccination(s)
Exclusion criteria
No informed consent
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 | NL44830.078.13 |