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

Tracking Information
First Submitted Date	February 12, 2009
First Posted Date	February 13, 2009
Last Update Posted Date	February 13, 2009
Study Start Date	March 2009
Estimated Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Study of the Development of Human Immune System of Newborns by Antigen Chips
Official Title	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	Observational
Study Design	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	Antibody Immune Profile
Intervention	Not Provided
Study Groups/Cohorts	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	Unknown status
Estimated Enrollment; (submitted: February 12, 2009)	100
Original Estimated Enrollment	Same as current
Estimated Study Completion Date	March 2011
Estimated Primary Completion Date	March 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria	Inclusion Criteria: Term and preterm newborns and their mothers; Age 1 day to 7 weeks Exclusion Criteria: Maternal immune dieases; Major congential malformations
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 7 Weeks (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Israel
Removed Location Countries
Administrative Information
NCT Number	NCT00843648
Other Study ID Numbers	SHEBA-08-5441-AM-CTIL
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr. Ayala Maayan, Sheba Medical Center
Study Sponsor	Sheba Medical Center
Collaborators	Weizmann Institute of Science
Investigators	Not Provided
PRS Account	Sheba Medical Center
Verification Date	February 2009