Yellow Fever Virus Vaccine Study - Clinical Trial

What is the Purpose of this Study?

We are studying the safety of a new kind of yellow fever vaccine.

What is the Condition Being Studied?

Vaccination Against Yellow Fever

Who Can Participate in the Study?

Adults ages 18-49 who:
- Are in general good health
- Do not routinely use any medication that affects the immune system

For more information about who can participate, please contact us at lynn.harrington@duke.edu or 919-971-5649.

What is Involved?

This study is divided into 2 parts: a screening period and a vaccination period.

If you choose to join the study, during the screening period you will:
- Come to our clinic for 1 visit
- Have a physical exam
- Have a blood draw

If you are eligible for the study, you will:
- Come to our clinic for 9 visits
- Be randomly assigned (like flipping a coin) to 1 of 3 groups
-- Group 1 will get a lower dose of the study vaccine
-- Group 2 will get a higher dose of the study vaccine
-- Group 3 will get a placebo (inactive substance)
- Get two doses of the study drug or placebo as shots in your arm 4 weeks apart
- Have 4 phone calls with the study team
- Have blood draws
- Give urine samples
- Answer questionnaires about how you are feeling after getting your shots

Participation in the study will end about 6 months after the second shot.

Study Details

Full Title
A Double Blind, Randomized, Placebo-Controlled, Phase 1 Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated Yellow Fever Virus Vaccine, HydroVax-002 YFV, in Healthy Adults
Principal Investigator
Infectious Disease Specialist
Protocol Number
IRB: PRO00102601
Phase
Phase I
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698