The main objective is to assess hallmarks of protective and waning immunity to vaccine preventable and non-preventable viral and bacterial diseases.in cases of various age groups and age-matched healthy controls. Secondary objectives are 1) to…
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Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequencies, functionality and specificity of biomarkers of specific B cell, T
cell, and early immunity (antibody levels, avidity, functionality, memory B
cells, plasma cells; cytokines, effector memory T cells, central memory T
cells; cytokines, chemokines, innate immune cells).
Secondary outcome
Date of birth, gender; use of antibiotics last 3 months; chronic diseases;
other disorders relevant for results of study; infectious diseases in past 5
years, including whether it was lab confirmed; presence or absence of clinical
symptoms during the infectious disease under study; medication relevant for
results of study; type of strain that caused the infectious disease under
study; vaccination status.
Background summary
In addition to the presence of antibodies, cell mediated immunity (CMI) plays
an important role in the protection against viruses and bacterial pathogens. In
general, humoral immune responses prevent infection by killing the
microorganism, whereas CMI prevents disease. Both responses are required for
protection against infectious diseases.
CMI involves multiple T lymphocyte (T-cell) populations of the adaptive immune
system, with unique antigen specificities and functions such as CD8+ cytotoxic
T-cells and CD4+ helper T-cells, also involved in helping antibody production.
Both humoral and CMI mechanisms of the adaptive immune response can be acquired
through natural infection or exposure to components of pathogens by
vaccination. Not only direct effector mechanisms are then primed but also base
levels of memory cells recalling specific antigens. These memory cells are
there to rapidly and more effectively respond to renewed encounters with the
pathogen, which is the mechanism behind vaccination. However, after an initial
sharp rise of these responses post-encounter, a period of gradual waning
follows. Studying characteristics of disease specific serological and CMI
mechanisms in cases versus healthy controls in early and late phase after
infection is important to unravel hallmarks of protection and waning immunity.
In cases with a vaccination history, the type of humoral response may for
example allow to distinguish between primary and secondary immune (vaccine)
failure. These kinds of studies provide important information for future
vaccination strategies and offer the opportunity to asses shared or unique
immune responses after natural infection or vaccination, as well as to compare
immune responses after infection with different viruses and pathogens.
Study objective
The main objective is to assess hallmarks of protective and waning immunity to
vaccine preventable and non-preventable viral and bacterial diseases.in cases
of various age groups and age-matched healthy controls. Secondary objectives
are 1) to assess the proportion of cases that are due to primary or to
secondary vaccine failure (in the case of measles and mumps), in order to
determine if waning immunity is responsible for infection amongst those
vaccinated and if additional steps need to be undertaken to prevent the risk of
additional cases occurring amongst the vaccinated Dutch population; 2) to
identify biomarkers of specific T-cell and B-cell responses for the evaluation
of the breadth of the humoral and CMI response shortly and longer after
infection; 3) to compare T-cell and B-cell responses after natural infection
with vaccine-induced responses; 4) to relate magnitude, quality and dominance
of pathogen specific T-cell responses to the quality of concomitant B-cell
responses; 5) to compare T-cell and B-cell responses after natural infection
between age-groups; 6) to compare the quality and quantity of humoral responses
in serum and saliva; 7) to compare T-cell and B-cell responses after natural
infection between different microorganisms; and 8) to assess the level of
waning immunity over time, both within-host and cross-sectionally
Study design
Controlled observational, non-therapeutic trial
Study burden and risks
Per blood collection 8-80 ml heparinized blood will be collected, volume
depends on age. The burden and risk is considered low. Blood collection might
be painful but only for a few seconds. Blood collection could result in a small
bruise at the needle stick location, which will disappear within a few days. To
reduce the burden, home visits will be performed.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
For cases entering the study at time point 1:
In order to be eligible to enter the study at time point 1, the following criteria must be met:
* A case has a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is within 3 months after diagnosis (*acute phase*)
* Willing to adhere to the protocol and perform all planned visits and sample collections
* Having given written informed consent themselves and/or through parents or legal representatives ;For cases first entering the study at time point 2:
In order to be eligible to enter the study at time point 2, the following criteria must be met:
* A case has had a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 9 months (± 1 month) after diagnosis or a case has had a symptomatic Bordetella pertussis infection that is laboratory confirmed and the time point of inclusion is around 12 months (± 1 month)
* A case does not enter the Periscope pertussis group
* Is willing to adhere to the protocol and perform all further planned visits and sample collections
* Has given written informed consent him/herself and/or through parents or legal representatives ;For cases first entering the study at time point 3:
In order to be eligible to enter the study at time point 3, the following criteria must be met:
* A case has had a symptomatic viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 18 months (± 2 months) after diagnosis
* A case does not enter the Periscope pertussis group
* Is willing to adhere to the protocol and perform the further planned visit and sample collection
* Has given written informed consent him/herself and/or through parents or legal representatives ;For cases first entering the study at time point 4:
In order to be eligible to enter the study at time point 4, the following criteria must be met:
* A case has had a viral/bacterial infection that is laboratory confirmed, and the time point of inclusion is around 36 months (± 3 months) after diagnosis
* A case does not enter the Periscope pertussis group
* Is willing to adhere to the protocol
* Has given written informed consent him/herself and/or through parents or legal representatives ;For age-matched controls:
* Negative clinical history and absence of a serological response against at least one of the panel of pathogens of interest for this study in the past 12 months.
* Having given written informed consent themselves and/or through parents or legal representatives
* Having been vaccinated, if applicable according to birth cohort, against measles, Bordetella pertussis, Streptococcus pneumoniae and/or mumps
Exclusion criteria
* Be or have been under immunosuppressive medical treatment, like cytostatics and prednisolons that might interfere with the results of the study, within the previous 3 months. In exemption to this criterion, short-term (*15 days), systemic immunosuppressive medication is permitted in case this medication is used to treat infections;
* Have any known primary or secondary immunodeficiency;
* Have a bleeding disorder or be under treatment with anticoagulants. In case of use of anti-coagulants, adult volunteers can be included if no spontaneous bleedings occurred in the month prior to venipuncture, if the dose of medication is stable (no changes in the month prior to venipuncture) and/or INR testing is performed at * 2 times a month, and if the INR value is below 3.5 (based on the information provided by the volunteer).;A control is not eligible when he/she reports to
* Have developed clinical symptoms of a virus or pathogen infection in the very short period of time between the identification as a control and the date of the home visit.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL46795.094.13 |
| OMON | NL-OMON22598 |