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

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ClinicalTrials.gov Identifier: NCT00843648
Recruitment Status : Unknown
Verified February 2009 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : February 13, 2009
Last Update Posted : February 13, 2009
Information provided by:

Study Description
Brief Summary:

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.

Condition or disease
Antibody Immune Profile

Detailed Description:
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.

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : March 2011
Groups and Cohorts

mother and preterm babies
term breastfed babies and mothers
term non breastfed babies and mothers
c-section babies and their mothers

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 7 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
term and preterm newborns and their mothers

Inclusion Criteria:

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

Exclusion Criteria:

  • Maternal immune dieases
  • Major congential malformations
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00843648

Sheba Medical Center Not yet recruiting
Ramat Gan, Israel, 52621
Contact: Ayala Maayan, MD    972-3-5302227    maayan@post.tau.ac.il   
Sponsors and Collaborators
Sheba Medical Center
Weizmann Institute of Science
More Information

Responsible Party: Dr. Ayala Maayan, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00843648     History of Changes
Other Study ID Numbers: SHEBA-08-5441-AM-CTIL
First Posted: February 13, 2009    Key Record Dates
Last Update Posted: February 13, 2009
Last Verified: February 2009

Keywords provided by Sheba Medical Center:
antibody immune profile