Vaccine ResponsePhase 4NCT05801978
Durability of Vaccine Responses
A Phase 4 study testing Live Attenuated Yellow Fever 17D Vaccine and Quadrivalent seasonal influenza vaccine in people with Vaccine Response, run by Emory University at 3 sites in United States.
Trial summary
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaccine Response
- What is being tested?
- Live Attenuated Yellow Fever 17D Vaccine and Quadrivalent seasonal influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Apr 2023to Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to understand and give informed consent.
- Age 18-50 years.
- Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination.
- Women of child bearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to tissue sampling procedures.
Who cannot join
- 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.
- History of Hepatitis B or Hepatitis C infection.
- Chronic clinically significant medical problems that could affect the immune response, require medication that would affect the immune response, or have signs or symptoms that could be confused with reactions to vaccination, including (but not limited to):
- Insulin dependent diabetes
- Severe heart disease (including arrhythmias)
Show all 21Show fewer
- Severe lung disease
- Severe liver disease
- Severe kidney disease
- Grade 4 hypertension (*Grade 4 hypertension per CTCAE criteria is defined as life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit))
- Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of uncontrolled autoimmune disorder.
- Pregnancy or breast feeding, or plans to become pregnant in the first 3 months of study participation.
- Receipt of blood products or immune globulin product within the prior 3 months.
- Active duty military.
- 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.
- Additional Exclusion Criteria for YF-17D Arm
- History of previous yellow fever, West Nile, Dengue, St. Louis encephalitis, or Japanese encephalitis vaccination or infection.
- Previous residence in a country where there is a risk of yellow fever virus (YFV) transmission
- History of allergy to eggs, chicken, or gelatin.
- Additional Exclusion Criteria for QIV Arm
- History of influenza infection within the same influenza season.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Nadie Rouphael, MD, 404-712-1435, nroupha@emory.edu
- Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Nadine Rouphael, MD, 404-712-1435, nroupha@emory.edu
- Recruiting
The Hope Clinic of Emory University
Decatur, Georgia, 30030
Nadine Rouphael, MD, 404-712-1435, nroupha@emory.edu
About this study
Official title: Systems Biological Assessment of the Durability of Vaccine Responses
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown.
This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.
Read the detailed description
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the influenza vaccine generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown.
This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts. The biologic samples will be collected from the blood (where antibodies are), the lymph nodes (where immune cells that make antibodies are present), and from the bone marrow (where long-lived cells that secrete antibodies are found). This study will take place at the Hope Clinic of Emory University.
The participants who express interest to ads for this research will be contacted by study staff who will provide further information about the study and conduct a primary evaluation of the eligibility criteria. If the participant is interested and verifies the eligibility criteria, a screening visit will be scheduled during which the study staff will go over the informed consent form with the participant. Other study procedures will be performed during this screening visit if the participant agrees to sign the informed consent form.
This study will include a screening visit, a vaccination visit, tissue sampling visits and a series of follow-up visits. During the tissue sampling visits, one or two procedures will be performed: A) Lymph node sampling during which an expert, guided by imaging, will take fine needle aspirates/ core biopsies from a lymph node. B) Bone marrow aspirate during which an expert will aspirate a small amount of bone marrow. Lymph node sampling procedures will be performed no more than two times each and bone marrow aspirations will be performed no more than three times each on the same participant. Other study procedures include a collection of medical history and medications taken, a urine pregnancy test for participants who are biologically able to become pregnant, a recording of vital signs, and a collection of adverse events that the participant experiences during their participation in the study. An HIV test is obtained as well at screening. Memory Aid will be completed by each participant.
The blood, lymph node, and bone marrow samples collected during this study will be stored and tested to evaluate how the immune system has responded to the vaccination over time. The remaining unused samples will be stored for use in future research.
This research will help advance the knowledge the study team has of how the immune system reacts to different vaccines, which will in turn, enable to identification of the factors that help predict the extent of durability of protection gained from a specific vaccine. This will also have a major impact on the way future vaccines are developed to provide long-lasting immunity against infections.
- Conditions
- Vaccine Response
- Being tested
- Live Attenuated Yellow Fever 17D Vaccine, Quadrivalent seasonal influenza vaccine
- Keywords
- Durability, Immune Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Live Attenuated Yellow Fever 17D VaccineBiological
The FDA-approved YF-17D (YF-VAX®) is a live attenuated vaccine manufactured by Sanofi Pasteur as a one-dose vial. The vaccine is prepared by culturing the 17D-204 strain of yellow fever virus, contains sorbitol and gelatin as a stabilizer, and contains no preservative. Each vial of vaccine is supplied with a separate vial of sterile diluent, which contains sodium chloride injection USP (United States Pharmacopeia) without a preservative.
Quadrivalent seasonal influenza vaccineBiological
The FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza.
| Study group | Role | What they receive |
|---|---|---|
| YF-17D Vaccination | Experimental | 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. Receives: Biological: Live Attenuated Yellow Fever 17D Vaccine |
| QIV Vaccination | Experimental | 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. Receives: Biological: Quadrivalent seasonal influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of neutralizing antibody (nAB) response against YF-17D in blood
Magnitude of neutralizing antibody responses against YF-17D at 270 days after vaccination among participants who receive YF-17D.
Measured: Up to 270 days after vaccination
Magnitude of neutralizing antibody (nAb) response against QIV in blood
Magnitude of neutralizing antibody responses against influenza vaccine strains at 270 days after vaccination among participants who receive QIV.
Measured: Up to 270 days after vaccination
Secondary outcomes (6)
Frequency of adverse events until day 28
Adverse events of grade 2 or higher (AE, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of vaccine, without any judgment about causality) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant.
Measured: Until day 28 after vaccination with YF-17D or QIV
Severity of adverse events until day 28
Adverse events (AE) will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0
Measured: Until day 28 after vaccination with YF-17D or QIV
Frequency of serious adverse events until day 270
Serious adverse events (SAE, defined as an AE that in the view of the investigator results in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect) will be identified during questioning or examination of participants during study visits or receiving a safety contact from a participant any time during the study.
Measured: Until day 270 after vaccination with YF-17D or QIV
Severity of serious adverse events until day 270
SAE will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.
Measured: Until day 270 after vaccination vaccination with YF-17D or QIV
Frequency of adverse events until day 7 after lymph node sampling and/or bone marrow aspiration
Adverse events (AE) of grade 2 or higher will be identified during questioning or examination of participants during study visits, telephone calls 7 +/- 3 days after lymph node sampling and/or bone marrow aspiration, or receiving a safety contact from a participant.
Measured: Until day 7 after lymph node sampling and/or bone marrow aspiration
Severity of adverse events until day 7 after lymph node sampling and/or bone marrow aspiration
SAE will be graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0.
Measured: Until day 7 after lymph node sampling and/ or bone marrow aspiration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start11 Apr 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccine ResponseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, Coefficient Giving
- Responsible party
- Principal investigator, Nadine Rouphael, Emory University
- Investigators
- Nadine Rouphael, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801978
- Sponsor's protocol ID
- STUDY00004930
- Other IDs
- #W911NF2320019
- Status last verified
- Jul 2026
- First submitted
- 25 Mar 2023
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systems Biological Assessment of the Durability of Vaccine Responses
- ClinicalTrials.gov ID
- NCT05801978
- Acronym / sponsor ID
- STUDY00004930
- Conditions
- Vaccine Response
- Keywords
- Durability, Immune Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Defense Advanced Research Projects Agency, Coefficient Giving
- Study start
- 11 Apr 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the quadrivalent influenza vaccine (QIV) generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown.
This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts.
Detailed description
The ability of the vaccines today to generate a long-lasting protection against infections varies greatly from one vaccine to another. The yellow fever vaccine (YF-17D) is one of the most successful vaccines ever developed, having been administered to over 600 million people globally. A single vaccination is known to induce durable protection over several decades. In contrast, the influenza vaccine generates an immunity that wanes quickly with no long-lasting protection. Currently, the duration of immune protection for new vaccines is difficult to predict during vaccine product development and can only be ascertained by a "wait and see" approach. This is due, in part, to the fact that some of the signals that activate a durable immune system protection remain unknown.
This study aims to provide a better understanding of this problem by vaccinating willing participants with either the FDA-approved yellow fever vaccine or the quadrivalent influenza vaccine and collecting baseline and follow-up biologic samples to compare how the immune system reacts. The biologic samples will be collected from the blood (where antibodies are), the lymph nodes (where immune cells that make antibodies are present), and from the bone marrow (where long-lived cells that secrete antibodies are found). This study will take place at the Hope Clinic of Emory University.
The participants who express interest to ads for this research will be contacted by study staff who will provide further information about the study and conduct a primary evaluation of the eligibility criteria. If the participant is interested and verifies the eligibility criteria, a screening visit will be scheduled during which the study staff will go over the informed consent form with the participant. Other study procedures will be performed during this screening visit if the participant agrees to sign the informed consent form.
This study will include a screening visit, a vaccination visit, tissue sampling visits and a series of follow-up visits. During the tissue sampling visits, one or two procedures will be performed: A) Lymph node sampling during which an expert, guided by imaging, will take fine needle aspirates/ core biopsies from a lymph node. B) Bone marrow aspirate during which an expert will aspirate a small amount of bone marrow. Lymph node sampling procedures will be performed no more than two times each and bone marrow aspirations will be performed no more than three times each on the same participant. Other study procedures include a collection of medical history and medications taken, a urine pregnancy test for participants who are biologically able to become pregnant, a recording of vital signs, and a collection of adverse events that the participant experiences during their participation in the study. An HIV test is obtained as well at screening. Memory Aid will be completed by each participant.
The blood, lymph node, and bone marrow samples collected during this study will be stored and tested to evaluate how the immune system has responded to the vaccination over time. The remaining unused samples will be stored for use in future research.
This research will help advance the knowledge the study team has of how the immune system reacts to different vaccines, which will in turn, enable to identification of the factors that help predict the extent of durability of protection gained from a specific vaccine. This will also have a major impact on the way future vaccines are developed to provide long-lasting immunity against infections.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YF-17D Vaccination | Experimental | Biological: Live Attenuated Yellow Fever 17D VaccineYellow 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. |
| QIV Vaccination | Experimental | Biological: Quadrivalent seasonal influenza vaccineQuadrivalent 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Able to understand and give informed consent.
- Age 18-50 years.
- Participants agree not to take any live vaccines 30 days before or after (14 days for inactivated) vaccination.
- Women of child bearing potential must agree to use effective birth control for the first 3 months of the study. A negative urine pregnancy test must be documented prior to vaccination and prior to tissue sampling procedures.
Key exclusion criteria (21 listed)
- 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.
- History of Hepatitis B or Hepatitis C infection.
- Chronic clinically significant medical problems that could affect the immune response, require medication that would affect the immune response, or have signs or symptoms that could be confused with reactions to vaccination, including (but not limited to):
- Thymus gland problems (such as myasthenia gravis, DiGeorge syndrome, thymoma) or removal of thymus gland or history of uncontrolled autoimmune disorder.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Live Attenuated Yellow Fever 17D VaccineThe FDA-approved YF-17D (YF-VAX®) is a live attenuated vaccine manufactured by Sanofi Pasteur as a one-dose vial. The vaccine is prepared by culturing the 17D-204 strain of yellow fever virus, contains sorbitol and gelatin as a stabilizer, and contains no preservative. Each vial of vaccine is supplied with a separate vial of sterile diluent, which contains sodium chloride injection USP (United States Pharmacopeia) without a preservative. | Biological | YF-17D Vaccination |
| Quadrivalent seasonal influenza vaccineThe FDA-approved quadrivalent seasonal influenza vaccine contains four distinct strains: two influenza A viruses and two influenza B viruses. The approved seasonal QIV will be purchased from the manufacturer to be given for each season of influenza. | Biological | QIV Vaccination |
Primary outcome
Magnitude of neutralizing antibody (nAB) response against YF-17D in blood
Time frame: Up to 270 days after vaccination
Magnitude of neutralizing antibody responses against YF-17D at 270 days after vaccination among participants who receive YF-17D.
Magnitude of neutralizing antibody (nAb) response against QIV in blood
Time frame: Up to 270 days after vaccination
Magnitude of neutralizing antibody responses against influenza vaccine strains at 270 days after vaccination among participants who receive QIV.
6 secondary outcomes
Frequency of adverse events until day 28
Time frame: Until day 28 after vaccination with YF-17D or QIV
Severity of adverse events until day 28
Time frame: Until day 28 after vaccination with YF-17D or QIV
Frequency of serious adverse events until day 270
Time frame: Until day 270 after vaccination with YF-17D or QIV
Severity of serious adverse events until day 270
Time frame: Until day 270 after vaccination vaccination with YF-17D or QIV
Frequency of adverse events until day 7 after lymph node sampling and/or bone marrow aspiration
Time frame: Until day 7 after lymph node sampling and/or bone marrow aspiration
Severity of adverse events until day 7 after lymph node sampling and/or bone marrow aspiration
Time frame: Until day 7 after lymph node sampling and/ or bone marrow aspiration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nadine Rouphael, MD principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Live Attenuated Yellow Fever 17D Vaccine and Quadrivalent seasonal influenza vaccine in people with Vaccine Response, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadine Rouphael, MD (404-712-1435, nroupha@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of neutralizing antibody (nAB) response against YF-17D in blood (time frame: Up to 270 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.