Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01967238
Recruitment Status : Recruiting
First Posted : October 22, 2013
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Rockefeller University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Biological: IM Pneumococcal, meningococcal, or flu vaccine Not Applicable

Detailed Description:
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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open Label Study of IgG Fc Glycan Composition in Human Immunity
Study Start Date : March 2013
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Biologic/Vaccine, Age 18-64 cohort
Vaccination. IM Pneumococcal, meningococcal, or flu vaccine
Biological: IM Pneumococcal, meningococcal, or flu vaccine
Volunteers given one of the 3 vaccines
Other Name: FluMist, Pneunomovax, or Menveo vaccine

Active Comparator: Biologic/Vaccine, Age 65-80 cohort
Vaccination. IM Pneumococcal, meningococcal, or flu vaccine
Biological: IM Pneumococcal, meningococcal, or flu vaccine
Volunteers given one of the 3 vaccines
Other Name: FluMist, Pneunomovax, or Menveo vaccine

Active Comparator: Vaccine, healthy adults
Vaccination. IM Pneumococcal, meningococcal, or flu vaccine
Biological: IM Pneumococcal, meningococcal, or flu vaccine
Volunteers given one of the 3 vaccines
Other Name: FluMist, Pneunomovax, or Menveo vaccine




Primary Outcome Measures :
  1. The degree of galactosylation, fucosylation and sialylation [ Time Frame: One Day ]
    The degree of galactosylation, fucosylation and sialylation of pre- vs. post- vaccination Fcs determined by lectin blot (Erythrina cristagalli, Aleuria Aurantia Lectin and Sambucus nigra lectins specific for galactose, fucose and 2,6-sialic acid, respectively) or by mass spectrometric analysis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 participation.
  • In the opinion of the investigator, the volunteer is unlikely to comply with the study protocol.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967238


Contacts
Layout table for location contacts
Contact: Rockefeller University Recruitment Office 1-800-RUCARES RUCARE@Rockefeller.edu

Locations
Layout table for location information
United States, New York
The Rockefeller University Recruiting
New York, New York, United States, 10065
Contact: Recruitment Specialist    800-782-2737      
Sponsors and Collaborators
Rockefeller University
Investigators
Layout table for investigator information
Principal Investigator: Taia T Wang, MD PhD Rockefeller Univesrity

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Rockefeller University
ClinicalTrials.gov Identifier: NCT01967238     History of Changes
Other Study ID Numbers: TWA-0804
First Posted: October 22, 2013    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rockefeller University:
immune response

Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs