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

NCT01967238 | Terminated Early Phase 1 Results FDA Drug

• 1 other identifier: TWA-0804
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

immune response

Outcome Measures

Primary Outcomes (1)

• The Percent (of 100%) of IgG With Galactosylation, Fucosylation and/or Sialylation

  The percent of Fc glycans that are galactosylation, fucosylation and/or 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. 100% of IgG were found to have these modifications.

  One Day

Study Arms (3)

Biologic/Vaccine, Age 18-64 cohort

ACTIVE COMPARATOR

Vaccination. IM Pneumococcal, meningococcal, or flu vaccine

Biological: IM Pneumococcal, meningococcal, or flu vaccine

Biologic/Vaccine, Age 65-80 cohort

ACTIVE COMPARATOR

Vaccination. IM Pneumococcal, meningococcal, or flu vaccine

Biological: IM Pneumococcal, meningococcal, or flu vaccine

Vaccine, healthy adults

ACTIVE COMPARATOR

Vaccination. IM Pneumococcal, meningococcal, or flu vaccine

Biological: IM Pneumococcal, meningococcal, or flu vaccine

Interventions

IM Pneumococcal, meningococcal, or flu vaccine BIOLOGICAL

Volunteers given one of the 3 vaccines

Also known as: FluMist, Pneunomovax, or Menveo vaccine

Biologic/Vaccine, Age 18-64 cohort; Biologic/Vaccine, Age 65-80 cohort; Vaccine, healthy adults

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rockefeller University: lead

Study Sites (1)

The Rockefeller University

New York, New York, 10065, United States

Location

Related Publications (1)

• Maamary J, Wang TT, Tan GS, Palese P, Ravetch JV. Increasing the breadth and potency of response to the seasonal influenza virus vaccine by immune complex immunization. Proc Natl Acad Sci U S A. 2017 Sep 19;114(38):10172-10177. doi: 10.1073/pnas.1707950114. Epub 2017 Sep 5.

  PMID: 28874545 DERIVED

MeSH Terms

Interventions

Influenza Vaccines; FluMist

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Taia Wang
• Organization: Stanford University

taiawang@stanford.edu

5103873941

Study Officials

• Taia T Wang, MD PhD

  Rockefeller Univesrity

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)