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

Tracking Information
First Received Date ^ICMJE	February 12, 2009
Last Updated Date	February 12, 2009
Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Study of the Development of Human Immune System of Newborns by Antigen Chips
Official Title ^ICMJE	Not Provided
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	term and preterm newborns and their mothers
Condition ^ICMJE	Antibody Immune Profile
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Not yet recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	March 2011
Estimated Primary Completion Date	March 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Term and preterm newborns and their mothers Age 1 day to 7 weeks Exclusion Criteria: Maternal immune dieases Major congential malformations
Gender	Both
Ages	up to 7 Weeks
Accepts Healthy Volunteers	No
Contacts ^ICMJE
Listed Location Countries ^ICMJE	Israel
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT00843648
Other Study ID Numbers ^ICMJE	SHEBA-08-5441-AM-CTIL
Has Data Monitoring Committee	No
Responsible Party	Dr. Ayala Maayan, Sheba Medical Center
Study Sponsor ^ICMJE	Sheba Medical Center
Collaborators ^ICMJE	Weizmann Institute of Science
Investigators ^ICMJE	Not Provided
Information Provided By	Sheba Medical Center
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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