Study Description

Participants will receive BG505 MD39.3 mRNA, BG505 MD39.3 gp151 mRNA, or BG505 MD39.3 gp151 CD4KO mRNA at doses of 100 mcg or 250mcg, administered via intramuscular (IM) injections into the deltoid muscle. Participants will be evaluated for safety and immune responses through blood and lymph node fine-needle aspiration collection at specified time points throughout the study.

A dose escalation plan will be implemented, whereby sentinel safety groups for each of the three low-dose groups in Part A will be enrolled and evaluated for safety two weeks after the first vaccination. If safety criteria are met, then enrollment of the Part B sentinel safety groups and the remainder of the Part A participants would commence. Safety for the sentinel groups in Part B will be assessed after the first vaccination before complete enrollment in Part B. In addition, standard safety evaluations will occur routinely throughout the trial.

Study Sponsor

U.S. National Institute of Allergy and Infectious Diseases (NIAID).

Intervention / Treatment 

• Biological: BG505 MD39.3 mRNA
• Biological: BG505 MD39.3 gp151 mRNA
• Biological: BG505 MD39.3 gp151 CD4KO mRNA

Study ID Numbers 

• NCT05217641
• HVTN 302
• DAIDS-ES ID: 38791