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Virus Therapy

Live Attenuated Influenza Vaccine for Influenza (PRISM Trial)

Phase 4
Waitlist Available
Led By Daniel Graciaa, MD, MPH, MSc
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* 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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights

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.

Who is the study for?
This trial is for individuals who want to help researchers understand the immune response to flu vaccines, particularly the nasal spray vaccine that's weaker and works differently in adults compared to children. Specific eligibility criteria are not provided.
What is being tested?
The study focuses on the live attenuated influenza vaccine given as a nasal spray. It aims to reveal why this flu vaccine's effectiveness varies between adults and children by studying participants' immune responses.
What are the potential side effects?
While specific side effects are not listed, typical reactions to live attenuated vaccines can include cold-like symptoms, mild body aches, and sneezing shortly after administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantification of Antibody Titers
Secondary study objectives
Frequency of Serious Adverse Events
Mean geometric fold rise in HAI titers

Side effects data

From 2011 Phase 4 trial • 38 Patients • NCT03101462
5%
Nasal Congestion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1 Licensed Trivalent FluMist
Group 1 Inactvated Trivalent Influenza Vaccine

Trial Design

1Treatment groups
Experimental Treatment
Group I: Live Attenuated Influenza VaccineExperimental Treatment1 Intervention
Participants receiving a single dose of the live attenuated influenza vaccine (LAIV).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Live Attenuated Influenza Vaccine
2011
Completed Phase 4
~4650

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,679 Previous Clinical Trials
2,579,104 Total Patients Enrolled
Boston UniversityOTHER
466 Previous Clinical Trials
9,954,405 Total Patients Enrolled
Daniel Graciaa, MD, MPH, MScPrincipal InvestigatorEmory University
~33 spots leftby Feb 2027
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