Dengue Vax/Zika Challenge Study (CIR 369)

Johns Hopkins CIR is conducting an outpatient research study to see if a dengue vaccine will prevent people from getting infected with zika virus. The vaccine used in this study (called TV003) has been tested for protection against dengue and studies show that it is safe and effective against the disease. Since dengue and zika are both flaviviruses, transmitted by mosquitoes, present in the same areas of the world, and there is no approved zika vaccine, we want to see if TV003 can produce cross protection (meaning protection from zika virus if you are given this vaccine).

 Study Breakdown

There are at least 2 screening visits to determine if you are eligible to participate in this study. The first screening is conducted under our adult screening study and will help us determine if you are a generally healthy person, while the second screening visit will provide more detailed information about the study and determine if you are eligible to be enrolled. 

The study is divided into 2 parts.  Each part lasts about 6 months. In the first part, study participants receive TV003 or placebo and return for 12 follow-up visits after vaccination. Six of these visits occur within the first 2 weeks, and the remaining visits are spread out over the 6 month time period. In the second part, study participants return 6 months after receiving TV003 or placebo to receive the zika challenge virus.  There are 19 follow up visits and one follow up phone call after challenge. Eleven of the visits in the second part of the study occurs within the first 2 weeks of receiving the challenge dose and the remaining visits are spread out over the 6 month time period. Participants must agree to both parts and be available for one year to complete the study. 

Who Can Participate? 

The following are some of the criteria study staff will use to determine if you qualify for the study. Other study criteria will be reviewed during the screening process.

• Healthy adults 18-40 years old 
• Willing to use certain methods of birth control 
• Willing to provide biological specimens including blood, urine, semen and vaginal secretions
• Able to visit the CIR for scheduled appointments
• Have a healthy immune system
• NOT pregnant, NOT breastfeeding 
• NOT planning to travel to areas where dengue and zika are prevalent during the study (for example, South America, Africa, Asia, Central America, Carribean, Bahamas)

If enrolled you will receive: 

• Up to $6100 for full study compliance (payment schedule will be reviewed at an in-person screening visit)
• Parking stickers or MTA tokens for in-person visits.