HVTN 322 Study

STUDY BASICS

Are you a healthy adult between 18 and 55? You may be eligible for a research study to look at the safety and immune responses to the different study vaccines individually and in different combinations. Study procedures will include blood draws, injections, the collection of a large amount of white blood cells, and the collection of cells from your lymph nodes. Compensation is provided.

STUDY PURPOSE

All the HVTN’s studies work toward our mission to find a safe and effective HIV vaccine. The main purpose of this study is to see if the study vaccines are safe to give to people, and whether people can take the study vaccines without becoming too uncomfortable. Another important goal of the study is to test if people’s immune systems respond to the study vaccines. 

COULD THIS STUDY BE RIGHT FOR YOU?

• not have HIV
• healthy and between 18 and 55 years of age
• women cannot be pregnant or breastfeeding

WHAT PARTICIPANTS CAN EXPECT

The 2 study vaccines are called DV201P-RNA (Study Vaccine 1) and DV202B1-RNA (Study Vaccine 2)

• Participants are assigned to one of four groups.
• Groups 1–3
  • Receives both vaccines.
  • Vaccines are given over 12 months.
  • Each group has a different dose amount: low, medium, or high.
• Group 4:
  • Receives vaccine 2 only.
  • Vaccine is given over 6 months.
  • The dose amount is decided using what we learn from Groups 1–3.
• Groups enroll one after another (sequentially).
• Participants are not randomized. Your group depends on when you join the study.

Study procedures will include blood draws, injections, and the collection of a large amount of white blood cells (also called leukapheresis), and the collection of cells from your lymph nodes (also called fine needle aspiration, or FNA). The main risks of these collection procedures can include pain, bruising, bleeding, and infection where the needle is inserted.