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

Stopped early · Early Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01967238

Run by

Rockefeller University

People needed

129

Starts

2013-03-01

Expected to finish

2023-03-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

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
• Any clinically significant abnormality on medical history or physical examination including history of immunodeficiency or autoimmune disease.

Where it is running

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

Full record on ClinicalTrials.gov

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