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

• ClinicalTrials.gov Identifier: NCT00843648
• Recruitment Status: Unknown
• First Posted: February 13, 2009
• Last Update Posted: February 13, 2009
• Sponsor: Sheba Medical Center
• 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

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

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