HVTN 302
Status:Ongoing
Phase:Open Label
Principal Investigator(s):Jesse Clark, MD, Sharon Riddler, MD
Objective:The HVTN 302 study will examine whether the following three experimental HIV mRNA vaccines are safe and can induce an immune response: 1) BG505 MD39.3 mRNA, 2) BG505 MD39.3 gp151 mRNA, and 3) BG505 MD39.3 gp151 CD4KO mRNA. See here for full press release by NIH.Approximately half of participants will undergo leukapheresis and other half will undergo fine needle aspiration.Last updated June 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label, Randomized
Arms and Assigned Interventions
DescriptionExperimental: Part A, Group 1: Low dose BG505 MD39.3 mRNA
18 participants Dose: 100mcg of BG505 MD39.3 mRNA formulated administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part A, Group 2: Low dose BG505 MD39.3 gp151 mRNA
18 participants Dose: 100mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part A, Group 3: Low dose BG505 MD39.3 gp151 CD4KO mRNA
18 participants Dose: 100mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 1: BG505 MD39.3 mRNA
18 participants Dose: 250mcg of BG505 MD39.3 mRNA administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 2: BG505 MD39.3 gp151 mRNA
18 participants Dose: 250mcg of BG505 MD39.3 gp151 mRNA administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: Part B, Group 3: BG505 MD39.3 gp151 CD4KO mRNA
18 participants Dose: 250mcg of BG505 MD39.3 gp151 CD4KO mRNA administered at months 0, 2, and 6
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT05217641
Trial Sponsors:
NIAID (DAIDS-ES ID: 38791)
Start Date
End Date
February 11, 2022
October 13, 2023
Enrollment:108
Age range:
18 Years ↔
55 Years
Population:Cisgender Men, Cisgender Women