An Open Label Study of IgG Fc Glycan Composition in Human Immunity

Conditions:Healthy Studies
Therapuetic Areas:Other
Age Range:18 - 80
Start Date:March 2013
End Date:March 2020
Contact:Rockefeller University Recruitment Office

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In order to produce better more effective vaccines, it is important to understand the
particulars of why individuals have an effective or ineffective immune response to
vaccination. We are going to examine specific aspects of the antibody (IgG Fc glycan) made by
healthy volunteers who receive different vaccines or who have a viral infection to understand
the nature of an effective (or less effective) vaccine response. The results of this research
could be used to develop adjuvants to increase/ improve vaccine response.

Antibodies are principle mediators of immunity against infections and they can also give rise
to autoimmune and inflammatory diseases. Two functional domains make up an IgG antibody - the
Fab domain binds to a specific target, while the Fc domain can interact with receptor
molecules to activate a pro- or anti- inflammatory state. The Fc domain of IgGs contains a
glycan that is variable in composition and its specific sugar components are an important
determinant of the biologic activity of IgGs in both protective and pathologic immune
responses. New disease treatments could be developed through purposeful manipulation of IgG
Fc glycans, but there is currently little known about how Fc glycan composition is regulated.
We plan to study this by evaluating whether vaccination can cause changes in Fc glycan
composition and, if so, whether signaling from helper T cells, age of the patient, and/or
route of vaccine administration are determinants of specific modifications that are triggered
by vaccination. Next, we will study effects that specific components within the Fc glycan
have on immunity against the common human pathogens Streptococcus pneumoniae and influenza
viruses using in vitro and in vivo models of infection. We will also study whether healthy
adults who have been previously infected with dengue, zika or chikungunya virus generate
distinct Fc glycoforms after vaccination compared with healthy adults who have not been
previously infected with any of these viruses.

Inclusion Criteria:

- Male or Female 18-80 years of age

- Healthy volunteers without significant medical problems

- Able to give informed consent to participate

- Willing to receive a single dose of an FDA-approved vaccine (either the influenza
virus, pneumococcal or meningococcal vaccine)

- Documented previous infection with dengue, zika or chikungunya virus or no history of
dengue, zika or chikungunya infection.

Exclusion Criteria:

- Prior allergic reaction to commercial vaccination

- For Flumist participants: Close contact with person with severely compromised immune
system requiring isolation

- For Flumist participants: Current illness that limits delivery to nasal airway (mild
illness, such as diarrhea or mild respiratory infection with or without fever, and
local infections do not apply)

- History of seizure disorder for Flumist group participants only.

- Participation in another clinical study of an investigational product currently or
within the past 90 days, or expected participation during this study.

- Any clinically significant acute or chronic medical condition requiring care of a
physician (e.g., diabetes, coronary artery disease, rheumatologic illness, malignancy,
substance abuse) that, in the opinion of the investigator, would preclude

- In the opinion of the investigator, the volunteer is unlikely to comply with the study

- Currently taking systemic steroids or other immunomodulatory medications including
anticancer medications and antiviral medications.

- Egg allergy

- Received the influenza vaccine less than 1 month ago and/or received the pneumococcal
and meningococcal vaccine less than 4 years ago

- Confirmed HIV infection, positive for hepatitis B surface antigen or positive for
hepatitis C antibodies.

- Is pregnant or lactating

- History of Guillain-Barre syndrome

- Poor venous access

- Unable to continue participation for 12 weeks

- Any clinically significant abnormality on medical history or physical examination
including history of immunodeficiency or autoimmune disease.
We found this trial at
1230 York Ave
New York, New York 10065
(212) 327-8000
Phone: 800-782-2737
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