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Virus Therapy

Vaccines for Durable Immune Response (DARPASB Trial)

Phase 4
Recruiting
Led By Nadine Rouphael, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of child bearing potential must agree to use effective birth control for the first 3 months of the study.
You are between the ages of 18-50.
Must not have
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 HIV infection, cancer, particularly leukemia, lymphoma, use of immunosuppressive or antineoplastic drugs or X-ray treatment). Persons with previous skin cancers or cured non-lymphatic tumors are not excluded from the study.
Timeline
Screening 1 day
Treatment Varies
Follow Up 9 months
Awards & highlights

DARPASB Trial Summary

This trial is looking at how different vaccines generate long-term protection against infections by comparing the body's immune response to two vaccines.

Who is the study for?
This trial is for healthy adults aged 18-50 who can consent and agree to use birth control if applicable. Excluded are those with severe liver or kidney disease, insulin-dependent diabetes, compromised immunity, high blood pressure risks, pregnancy, breastfeeding intentions within 3 months of the study start, recent receipt of blood products or immune globulin product. Military personnel are also excluded.Check my eligibility
What is being tested?
The study compares the long-term immune response between two vaccines: the yellow fever vaccine (YF-17D) known for its lasting protection and the seasonal quadrivalent influenza vaccine (QIV), which has short-lived immunity effects. Participants will receive one of these FDA-approved vaccines and provide biological samples over time for analysis.See study design
What are the potential side effects?
Potential side effects from YF-17D may include mild pain at injection site, headache, muscle aches; rare serious side effects like allergic reactions exist. QIV might cause soreness where shot was given, low-grade fever or muscle aches; severe allergies to components like eggs could lead to significant reactions.

DARPASB Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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Women of reproductive age must commit to utilizing effective contraception methods for the initial quarter of the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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You have had a serious allergic reaction to a vaccine or vaccine-related products in the past, including Guillain-Barré syndrome.
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I have a condition that weakens my immune system, but not skin cancer or cured non-lymphatic tumors.
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I have a history of thymus gland issues or an uncontrolled autoimmune disorder.

DARPASB Trial Timeline

Screening ~ 1 day
Treatment ~ Varies
Follow Up ~9 months
This trial's timeline: 1 day for screening, Varies for treatment, and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Magnitude of neutralizing antibody (nAB) response against YF-17D in blood
Magnitude of neutralizing antibody (nAb) response against QIV in blood
Secondary outcome measures
Frequency of adverse events until day 28
Frequency of adverse events until day 7 after lymph node sampling and/or bone marrow aspiration
Frequency of serious adverse events until day 270
+3 more

DARPASB Trial Design

2Treatment groups
Experimental Treatment
Group I: YF-17D VaccinationExperimental Treatment1 Intervention
Yellow Fever Vaccine (YF-17D) vaccination: Eligible participants will be asked to read the Vaccine Information Sheet for YF-17D per the Centers for Disease Control and Prevention (CDC) guidelines. Participants will then receive the YF-17D vaccine. They will be observed for a minimum of 20 minutes for any immediate hypersensitivity reactions. They will also be given the International Certificate of Vaccination documenting receipt of YF-17D.
Group II: QIV VaccinationExperimental Treatment1 Intervention
Quadrivalent seasonal influenza vaccine (QIV) vaccination: Eligible participants will be asked to read the Vaccine Information Sheet for QIV per the CDC guidelines. Participants will then receive QIV. They will be observed for a minimum of 20 minutes for any immediate hypersensitivity reactions.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Defense Advanced Research Projects AgencyFED
18 Previous Clinical Trials
78,863 Total Patients Enrolled
Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,636 Total Patients Enrolled
Nadine Rouphael, MDPrincipal InvestigatorEmory University
16 Previous Clinical Trials
843 Total Patients Enrolled

Media Library

Live Attenuated Yellow Fever 17D Vaccine (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05801978 — Phase 4
Healthy Subjects Research Study Groups: QIV Vaccination, YF-17D Vaccination
Healthy Subjects Clinical Trial 2023: Live Attenuated Yellow Fever 17D Vaccine Highlights & Side Effects. Trial Name: NCT05801978 — Phase 4
Live Attenuated Yellow Fever 17D Vaccine (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05801978 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for the trial restricted to individuals aged 65 or older?

"Eligible participants must be of legal age and under the age of fifty for inclusion in this clinical trial."

Answered by AI

Who is eligible to partake in this medical experiment?

"To meet the eligibility criteria of this medical trial, applicants should possess an immunity to vaccine and be between 18-50 years old. This study has a total capacity for 60 participants."

Answered by AI

Has the YF-17D Vaccination gained regulatory approval?

"YF-17D Vaccination has already been authorized for use, so it was graded a 3 on our team's safety scale."

Answered by AI

What are the fundamental aims of this experiment?

"This medical trial aims to assess the magnitude of neutralizing antibody response against QIV in blood, over a period up to 270 days after vaccination. Secondary objectives include measuring any adverse events until day 28 and serious adverse events (e.g., death or hospitalization) until day 270; both outcomes will be graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0 guidelines."

Answered by AI

Is enrollment to this experiment currently open?

"By referencing clinicaltrials.gov, it can be determined that this medical experiment is not actively recruiting participants at the moment; however, there are four other trials that require volunteers as of now. This trial was first posted on April 1st 2023 and last updated on March 25th 2023."

Answered by AI

Who else is applying?

What site did they apply to?
The Hope Clinic of Emory University
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Systems Biological Assessment of the Durability of Vaccine Responses
Nadine Rouphael 2023. "Systems Biological Assessment of the Durability of Vaccine Responses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05801978.
~35 spots leftby Sep 2025
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