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Virus Therapy

Nasal Spray Vaccine for Flu (PRISM Trial)

Phase 4
Recruiting
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
Be between 18 and 65 years old
Must not have
History of HIV, Hepatitis B or Hepatitis C infection
Chronic clinically significant medical problems that could be considered active or unstable (diagnosed within the past 3 months or requiring a change in medication within the past 3 months) 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 30
Awards & highlights
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

Summary

"This trial aims to study how the human immune system responds to nasal spray flu vaccines to improve their effectiveness in adults, as they currently work better in children."

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
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I understand the study and can agree to participate.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a history of HIV, Hepatitis B, or Hepatitis C.
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I do not have any severe or unstable health conditions diagnosed or treated recently.
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I have not received blood products or immune globulin in the last 3 months.
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I have had the flu or a flu shot this or last flu season.
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I haven't taken immune-modifying drugs or steroids like prednisone (>20mg/day) for more than a week in the last 3 months.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
1,701 Previous Clinical Trials
2,604,681 Total Patients Enrolled
Boston UniversityOTHER
473 Previous Clinical Trials
9,990,783 Total Patients Enrolled
Daniel Graciaa, MD, MPH, MScPrincipal InvestigatorEmory University
~33 spots leftby Feb 2027
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