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Imm-f@ct: Characterization of immune mechanisms in measles and other infectious diseases; role of specificities, functions, maintenance and fitness

Imm-f@ct: Characterization of immune mechanisms in measles and other infectious diseases; role of specificities, functions, maintenance and fitness - Imm-f@ct

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47081
Enrollment
840
Registered
2014-01-20
Start date
2014-05-29
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infectious diseases pathogens

Interventions

None listed

Sponsors

RIVM
Lead Sponsor

Eligibility

Age
2 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)