Durability of Vaccine Responses

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

Qualifiers

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

Treatments tested in this trial

  • Live Attenuated Yellow Fever 17D Vaccine
  • Quadrivalent seasonal influenza vaccine

Treatment groups

66 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Emory University

Lead sponsor

Defense Advanced Research Projects Agency

Collaborator

Open Philanthropy

Collaborator