Yellow Fever Vaccine for Yellow Fever

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
United States Army Medical Research Institute of Infectious Diseases, Frederick, MD
Yellow Fever+2 More
Yellow Fever Vaccine - Biological
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This is an open-label, randomized, exploratory study to evaluate the human immune response to reduced subcutaneous (SQ) dosing of Yellow Fever vaccine compared to the standard FDA approved subcutaneous vaccination dose. The current dose of the US FDA licensed Yellow Fever vaccine is approximately 55,000 plaque-forming unit(s) (PFU) in 0.5 mL administered SQ. Using the licensed dosage as standard, investigators are evaluating reduced doses of 1/5th (0.10 mL) and 1/10th (0.05 mL) Yellow Fever vaccine (YF-VAX).

Eligible Conditions

  • Yellow Fever

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Up to one year following vaccination.

Day 14
Viremia
Up to one year following vaccination.
Adverse Events
Neutralizing Antibody Response

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Side Effects for

MenACWY-CRM197 (Combined)
4%Headache
2%Injection site pain
2%Influenza like illness
1%Nasopharyngitis
0%Injury
0%Intervertebral disc protrusion
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01466387) in the MenACWY-CRM197 (Combined) ARM group. Side effects include: Headache with 4%, Injection site pain with 2%, Influenza like illness with 2%, Nasopharyngitis with 1%, Injury with 0%.

Trial Design

6 Treatment Groups

Group 1
1 of 6
Group 3
1 of 6
Group 2
1 of 6
Standard Dose (Group 1)
1 of 6
Fractional dose (Group 2)
1 of 6
Fractional dose (Group 3)
1 of 6
Active Control
Experimental Treatment

88 Total Participants · 6 Treatment Groups

Primary Treatment: Yellow Fever Vaccine · No Placebo Group · Phase 4

Fractional dose (Group 2)
Biological
Experimental Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Fractional dose (Group 3)
Biological
Experimental Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Group 1
Biological
ActiveComparator Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Group 3
Biological
ActiveComparator Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Group 2
Biological
ActiveComparator Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Standard Dose (Group 1)
Biological
ActiveComparator Group · 1 Intervention: Yellow Fever Vaccine · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Yellow Fever Vaccine
2016
Completed Phase 3
~1400

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to one year following vaccination.
Closest Location: United States Army Medical Research Institute of Infectious Diseases · Frederick, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2021First Recorded Clinical Trial
1 TrialsResearching Yellow Fever
1 CompletedClinical Trials

Who is running the clinical trial?

US Army Medical Research Institute of Infectious DiseasesLead Sponsor
13 Previous Clinical Trials
1,800 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a negative pregnancy test if you are male or female.
You are negative for HIV and hepatitis B surface antigen (HBsAg) and hepatitis C antibody (following HIV and hepatitis testing, subjects will be provided with counseling and referral for health care if any test is positive).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.