Najit CHIKV 24-0001 (Vaccine Study for Health Volunteers)

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:
  • Are healthy and do not have significant medical problems
  • Have not made any changes to medication use in the past 60 days
  • Are not immunocompromised
  • Do not have a history of chikungunya virus infection
For more information, contact the study team at stephanie.smith@duke.edu.

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?

Description

The study lasts about 8 months. If you choose to join the study, you will:
  • Visit our clinic for a screening visit to confirm that you are eligible
  • Visit our clinic for 2 vaccination visits and get 2 doses of the study vaccine or placebo (inactive substance), which are given as shots
  • Have 7 follow-up visits after you get the vaccine or placebo
  • Have 4 phone calls with the team at different times to see how you are doing
  • Get compensation for participating

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

Principal Investigator

Emmanuel
Walter

Protocol Number

PRO00115697

Phase

I

Enrollment Status

Open to Enrollment