Durability of Vaccine Responses

NCT05801978 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY00004930#W911NF2320019
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Vaccine Response

Keywords

Durability; Immune Response

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 270 days after vaccination

Secondary Outcomes (6)

• Frequency of adverse events until day 28

  Until day 28 after vaccination with YF-17D or QIV

• Severity of adverse events until day 28

  Until day 28 after vaccination with YF-17D or QIV

• Frequency of serious adverse events until day 270

  Until day 270 after vaccination with YF-17D or QIV

• Severity of serious adverse events until day 270

  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

  Until day 7 after lymph node sampling and/or bone marrow aspiration

Study Arms (2)

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.

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.

Biological: Quadrivalent seasonal influenza vaccine

Interventions

Live Attenuated Yellow Fever 17D Vaccine BIOLOGICAL

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.

YF-17D Vaccination

Quadrivalent seasonal influenza vaccine BIOLOGICAL

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.

QIV Vaccination

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Emory University: lead
• Defense Advanced Research Projects Agency: collaborator
• Open Philanthropy: collaborator

Study Sites (3)

Emory University Hospital

Atlanta, Georgia, 30322, United States

RECRUITING

Emory Winship Cancer Institute

Atlanta, Georgia, 30322, United States

RECRUITING

The Hope Clinic of Emory University

Decatur, Georgia, 30030, United States

RECRUITING

Study Officials

• Nadine Rouphael, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine Rouphael, MD

CONTACT

404-712-1435; nroupha@emory.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 6, 2023
• Study Start: April 11, 2023
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Locations

US (3)