Revealing Protective Immunity to Influenza Using Systems Immunology

NCT06501963 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00007610
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are to better understand the human immune response to influenza vaccines, specifically the live attenuated (weakened) influenza vaccine given as a nasal spray. Better understanding why this vaccine does not work as well in adults as it does in children may help design better influenza vaccines.

Conditions

Influenza

Keywords

Vaccination

Outcome Measures

Primary Outcomes (1)

• Quantification of Antibody Titers

  The immunogenicity of the live attenuated influenza vaccine (LAIV) is evaluated by the quantification of antibody titers using hemagglutination inhibition (HAI) assays. HAI titers are used as markers of part of the immune response to influenza and may vary by influenza strain.

  Day 30

Secondary Outcomes (2)

• Geometric Mean Fold Rise in HAI Titers

  Day 30

• Number of Serious Adverse Events

  Up to Day 30

Study Arms (1)

Live Attenuated Influenza Vaccine

EXPERIMENTAL

Participants receiving a single dose of the live attenuated influenza vaccine (LAIV).

Biological: Live Attenuated Influenza Vaccine

Interventions

Live Attenuated Influenza Vaccine BIOLOGICAL

The FDA-approved live attenuated seasonal influenza vaccine (LAIV) (FluMist®, AstraZeneca) is licensed in the US for people 2-49 years of age. The approved seasonal LAIV at the time of study enrollment will be obtained from the manufacturer. LAIV will be administered by a study nurse or health care provider at the Hope Clinic as a single 0.2 milliliter (mL) dose given as 0.1 mL spray in each nostril.

Also known as: FluMist

Live Attenuated Influenza Vaccine

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Able to understand and give informed consent
• Participants of child bearing potential must agree to use effective birth control for the duration of the study. A negative urine pregnancy test must be documented prior to vaccination.

You may not qualify if:

• History of allergy or serious adverse reaction, including Guillain-Barré syndrome, to a vaccine or vaccine products
• History of a medical condition resulting in impaired immunity such as active solid tumors, leukemia, lymphoma, chemotherapy or radiation therapy, autoimmune conditions, or splenic dysfunction. Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
• History of asthma, cochlear implant, or active cerebrospinal fluid leak
• Use of immune modifying drugs including: systemic steroids for more than 1 week (such as prednisone \> 20mg/day), chronic administration (more than 14 days total) of immunosuppressive or immunomodulatory drugs in the prior 3 months
• History of HIV, Hepatitis B or Hepatitis C infection
• Chronic clinically significant medical problems that could be considered active or unstable (i.e diagnosed within the past 3 months or requiring a change in medication within the past 3 months). This is including (but not limited to):
• Insulin dependent diabetes
• Severe heart disease (including arrhythmias)
• Severe lung disease
• Severe liver disease
• Severe kidney disease
• Severe hypertension: defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit).
• Congenital genetic syndromes (e.g., trisomy 21)
• Body Mass Index (BMI) \> 35
• Pregnancy or breast feeding, or plans to become pregnant in the next month

Sponsors & Collaborators

• Emory University: lead
• Boston University: collaborator

Study Sites (1)

Hope Clinic of the Emory Vaccine Center

Decatur, Georgia, 30030, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; FluMist

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Daniel Graciaa, MD, MPH, MSc
• Organization: Emory University

dsgraci@emory.edu

404-712-1370

Study Officials

• Daniel Graciaa, MD, MPH, MSc

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 9, 2024
• First Posted: July 15, 2024
• Study Start: October 14, 2024
• Primary Completion: April 1, 2025
• Study Completion: April 1, 2025
• Last Updated: March 30, 2026
• Results First Posted: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Individual participant data will be available for sharing following publication of the results from this study.
• Access Criteria: Data will be available for sharing with any researchers who wishes to access the database, or any purpose. Data will be shared via Immport (https://immport.niaid.nih.gov/home) and Zenodo (https://zenodo.org/)

Locations

US (1)