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临床试验/NL-OMON22598
NL-OMON22598已完成不适用

Characterization of immune mechanisms in measles and other infectious diseases; role of specificities, functions, maintenance and fitness.

RIVM0 个研究点目标入组 419 人开始时间: 待定最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
419

研究概览

简要总结

Publications using study material (untill 12-04-2022) Kaaijk P, Pimentel VO, Emmelot ME, Poelen M, Cevirgel A, Schepp RM, den Hartog G, Reukers DFM, Beckers L, van Beek J, van Els CACM, Meijer A, Rots NY, de Wit J. Children and Adults With Mild COVID-19: Dynamics of the Memory T Cell Response up to 10 Months. Front Immunol. 2022 Feb 7;13:817876. doi: 10.3389/fimmu.2022.817876. PMID: 35197982; PMCID: PMC8858984. Lambert Eleonora E., van Twillert Inonge, Beckers Lisa, Poelen Martien C. M., Han Wanda G. H., Pieren Daan K. J., van Els Cécile A. C. M. Reduced Bordetella pertussis-specific CD4+ T-Cell Responses at Older Age. 2022. Frontiers in Aging. Aging and the immune system. Doi: 10.3389/fragi.2021.737870. ISSN=2673-6217 https://www.frontiersin.org/article/10.3389/fragi.2021.737870. https://doi.org/10.3389/fragi.2021. Lanfermeijer J, Nühn MM, Emmelot ME, Poelen MCM, van Els CACM, Borghans JAM, van Baarle D, Kaaijk P, de Wit J. Longitudinal Characterization of the Mumps-Specific HLA-A2 Restricted T-Cell Response after Mumps Virus Infection. Vaccines (Basel). 2021 Dec 3;9(12):1431. doi: 10.3390/vaccines9121431. PMID: 34960178; PMCID: PMC8707000. Lesne E, Cavell BE, Freire-Martin I, Persaud R, Alexander F, Taylor S, Matheson M, van Els CACM, Gorringe A. Acellular Pertussis Vaccines Induce Anti-pertactin Bactericidal Antibodies Which Drives the Emergence of Pertactin-Negative Strains. Front Microbiol. 2020 Aug 27;11:2108. doi: 10.3389/fmicb.2020.02108. PMID: 32983069; PMCID: PMC7481377. de Wit J, Emmelot ME, Poelen M, van Binnendijk R, van der Lee S, van Baarle D, Han WGH, van Els CACM, Kaaijk P. Mumps infection but not childhood vaccination induces persistent polyfunctional CD8+ T-cell memory. J Allergy Clin Immunol. 2018 May;141(5):1908-1911.e12. doi: 10.1016/j.jaci.2017.11.047

研究设计

研究类型
Observational

入排标准

入选标准

  • 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
  • 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

排除标准

  • Any of the following criteria will exclude a volunteer from participation, at the entry into the study:
  • 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.

研究者

发起方
RIVM

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