Understanding how the flu vaccine works in adults

Revealing Protective Immunity to Influenza Using Systems Immunology

This study is testing how well the nasal flu vaccine works in adults compared to children to find out why it might not be as effective for grown-ups.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 49 Years
• Sex: All
• Sponsor: Emory University (other)
• Drugs / interventions: chemotherapy, radiation, prednisone
• Locations: 1 site (Decatur, Georgia)
• Trial ID: NCT06501963 on ClinicalTrials.gov

What this trial studies

This study aims to investigate the immune response to the live attenuated influenza vaccine (LAIV) administered as a nasal spray, particularly focusing on why its effectiveness is lower in adults compared to children. By analyzing the differences in immune responses, the research seeks to identify factors that contribute to the reduced efficacy of LAIV in adults, which may lead to the development of improved influenza vaccines. The study involves administering the vaccine to eligible participants and monitoring their immune responses over time.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-49 who are willing to participate and meet the eligibility criteria.

Not a fit: Patients with a history of severe allergic reactions to vaccines or those with compromised immune systems may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to the development of more effective influenza vaccines for adults, enhancing protection against the virus.

How similar studies have performed: Other studies have shown varying success with similar approaches, but this specific investigation into adult responses to LAIV is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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
* History of influenza infection or vaccination within the current or previous influenza season
* Receipt of blood products or immune globulin product within the prior 3 months
* History of excessive alcohol consumption, drug use, psychiatric conditions, social conditions or occupational conditions that in the opinion of the investigator would preclude compliance with the trial
* Receipt of any live vaccines 30 days before, or plans to receive any live vaccines 30 days after vaccination
* Receipt of any inactivated vaccines 14 days before, or plans to receive any inactivated vaccines 14 days after vaccination
* Receipt of any non-registered or other investigational product in 30 days before, or plans to receive any other investigational product 30 days after vaccination
* Temporary Exclusion Criteria:

  * Fever (temperature ≥38.0°C) or coryzal symptoms within 72 hours prior to vaccination
  * Receipt of antipyretics within 6 hours prior to vaccination

Where this trial is running

Decatur, Georgia

• Hope Clinic of the Emory Vaccine Center — Decatur, Georgia, United States (RECRUITING)

Study contacts

• Principal investigator: Daniel Graciaa, MD, MPH, MSc — Emory University
• Study coordinator: Daniel Graciaa, MD, MPH, MSc

Conditions: Influenza, Vaccination