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Study of the Development of Human Immune System of Newborns by Antigen Chips

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00843648
First received: February 12, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 12, 2009
February 12, 2009
March 2009
March 2010   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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Study of the Development of Human Immune System of Newborns by Antigen Chips
Not Provided

The immune system is a dynamic, constantly evolving network. Excluding autoimmune diseases, healthy individuals are also known to have a large number of circulating antibodies that can recognize proteins of their own tissues. These antibodies are known as natural antibodies and previous studies suggested that some features of these "self" components are shared by individuals in certain physiological states. Thus, monitoring self immunoglobulins can provide an overview of the various states of the immune system. To do so, and in the process to obtain systems biology view of the immune system, the newly developed Antigen Chip technology has been used.

To further investigate this subject we plan to carry out broader investigations that will be conducted in collaboration with the group of Prof. Eshel Ben-Jacob from the university of Tel-Aviv and Prof. Irun Cohen from the Weizmann Institute that have the required experimental and analytical expertise and facilities. The studies will include follow-up on the immune state of babies and their mothers for several months post birth using the Antigen Chip and analyzed by the Immune holography method. The investigations will also include comparative studies between the immune signature of different body fluids, the effects of feeding, and the effect method and time of labor.

Antibody reactivities are traditionally studied by their individual reactivities to one or only a few antigens, whereas only a small number of studies have focused on the repertoires of antibodies to large numbers of defined antigens. Only recently, a new technology for system level analysis, the immune microarrays (or antigen chips) was introduced [Quintana 2004, Quintana and Cohen 2004, Robinson 2006]. This technology is capable of detecting patterns of antibodies binding to many hundreds of antigens, foreign or self and thus allowing a systems biology view of immune system. To create the antigen chips, a robotic apparatus is used to spot the antigen molecules of choice - proteins, peptides, sugars, lipids, nucleic acids - to a coated glass slide. These antigens are covalently linked to the surface of the slide and a drop of blood serum or any other body fluid can be tested for antibodies binding to hundreds of these antigen spots. The subject's bound antibodies are detected using fluorescence-labeled second antibodies and the reactions are monitored by laser activation.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

term and preterm newborns and their mothers

Antibody Immune Profile
Not Provided
  • preterms
    mother and preterm babies
  • term-bfing
    term breastfed babies and mothers
  • term-PIF
    term non breastfed babies and mothers
  • c-section
    c-section babies and their mothers
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
100
March 2011
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Term and preterm newborns and their mothers
  • Age 1 day to 7 weeks

Exclusion Criteria:

  • Maternal immune dieases
  • Major congential malformations
Both
up to 7 Weeks
No
Israel
 
NCT00843648
SHEBA-08-5441-AM-CTIL
No
Dr. Ayala Maayan, Sheba Medical Center
Sheba Medical Center
Weizmann Institute of Science
Not Provided
Sheba Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP