Purpose of this Study
We are doing this study to find out if an investigational vaccine (HydroVax-005 CHIKV - the study vaccine) is a safe and effective option to protect against chikungunya virus. Chikungunya virus is spread by mosquitos that are most common in Africa, Asia, and India. Infection with the virus can cause serious disease in older adults, children, and people with weaker immune systems.
Who Can Participate?
Eligibility
Adults ages 18-49 who:<ul>
<li>Are healthy and do not have significant medical problems</li>
<li>Have not made any changes to medication use in the past 60 days</li>
<li>Are not immunocompromised</li>
<li>Do not have a history of chikungunya virus infection</li></ul>
For more information, contact the study team at <a href= "mailto: stephanie.smith@duke.edu">stephanie.smith@duke.edu.</a>
<li>Are healthy and do not have significant medical problems</li>
<li>Have not made any changes to medication use in the past 60 days</li>
<li>Are not immunocompromised</li>
<li>Do not have a history of chikungunya virus infection</li></ul>
For more information, contact the study team at <a href= "mailto: stephanie.smith@duke.edu">stephanie.smith@duke.edu.</a>
Age Range
18-49
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
Yes
What is Involved?
The study lasts about 8 months. If you choose to join the study, you will:<ul>
<li>Visit our clinic for a screening visit to confirm that you are eligible</li>
<li>Visit our clinic for 2 vaccination visits and get 2 doses of the study vaccine or placebo (inactive substance), which are given as shots</li>
<li>Have 7 follow-up visits after you get the vaccine or placebo</li>
<li>Have 4 phone calls with the team at different times to see how you are doing</li>
<li>Get compensation for participating</li>
<li>Visit our clinic for a screening visit to confirm that you are eligible</li>
<li>Visit our clinic for 2 vaccination visits and get 2 doses of the study vaccine or placebo (inactive substance), which are given as shots</li>
<li>Have 7 follow-up visits after you get the vaccine or placebo</li>
<li>Have 4 phone calls with the team at different times to see how you are doing</li>
<li>Get compensation for participating</li>
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
Study Details
Full Title
A Double Blind, Randomized, Placebo-Controlled, Phase 1 Dose Escalation Trial to Evaluate the Safety and Immunogenicity of an Inactivated Chikungunya Virus Vaccine, HydroVax-005 CHIKV, in Healthy Adults
Study Website
Principal Investigator
Emmanuel
Walter
Protocol Number
PRO00115697
Phase
I
Enrollment Status
Open to Enrollment