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

May 31, 2022 updated by: Rockefeller University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • The Rockefeller University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • FluMist, Pneunomovax, or Menveo vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rockefeller University

Investigators

  • Principal Investigator: Taia T Wang, MD PhD, Rockefeller Univesrity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ANTICIPATED)

March 1, 2023

Study Completion (ANTICIPATED)

March 1, 2024

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (ESTIMATE)

October 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 31, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TWA-0804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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