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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Weizmann Institute of Science
Information provided by:
Sheba Medical Center

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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified 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