Durability of Vaccine Responses
ConditionVaccine Response
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-50
SponsorEmory University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Insulin dependent diabetes
Trial design
Design model
Parallel
Treatments tested in this trial
Live Attenuated Yellow Fever 17D Vaccine
Biological/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.
Quadrivalent seasonal influenza vaccine
Biological/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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: YF-17D VaccinationExperimental treatment 1 intervention
Group B: QIV VaccinationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 270 days after vaccination2
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.
Time frame
Up to 270 days after vaccinationSecondary outcomes
1
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.
Time frame
Until day 28 after vaccination with YF-17D or QIV2
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
Time frame
Until day 28 after vaccination with YF-17D or QIV3
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.
Time frame
Until day 270 after vaccination with YF-17D or QIV4
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.
Time frame
Until day 270 after vaccination vaccination with YF-17D or QIVSponsors and contacts
Click on the lead sponsor to view all of their trials.
Emory University
Lead sponsor
Defense Advanced Research Projects Agency
Collaborator
Open Philanthropy
Collaborator
Source ClinicalTrials.gov