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

NCT ID: NCT00843648

Last Updated: 2009-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2011-03-31

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.

Conditions

Antibody Immune Profile

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

preterms

mother and preterm babies

No interventions assigned to this group

term-bfing

term breastfed babies and mothers

No interventions assigned to this group

term-PIF

term non breastfed babies and mothers

No interventions assigned to this group

c-section

c-section babies and their mothers

No interventions assigned to this group

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 7 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weizmann Institute of Science

OTHER

Sponsor Role: collaborator

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Sheba Medical Center

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Facility Contacts

Ayala Maayan, MD

Role: primary

maayan@post.tau.ac.il

972-3-5302227

Other Identifiers

SHEBA-08-5441-AM-CTIL

Identifier Type: -

Identifier Source: org_study_id