RV 546
Status:Ongoing
Phase:I
Principal Investigator(s):Punnee Pitisuttithum, Sorachai Nitayaphan
Objective:Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920
The purpose of this study is to define the safety and immunogenicity of IHV01 and A244/AHFG with and without ALFQ at a full dose and at a fractional dose (one-fifth of a full dose) in a late boost setting for participants who had previously received a late boost of AIDSVAX®B/E with or without ALVAC in RV306. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood, lymph nodes, sigmoid tissue, and mucosal specimens/secretions will be collected to assess humoral, cell-mediated, innate, and mucosal immune responses.
Last updated September 18, 2022
Prevention Option(s):HIV Vaccine
Study Design:Double-blind, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg).
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg).
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg) plus ALFQ (approximately 0.5mL).
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg) plus ALFQ (approximately 0.5mL).
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT04658667
Trial Sponsors:
U.S. Army Medical Research and Development Command
Start Date
End Date
January 18, 2022
March 1, 2027
Enrollment:120
Age range:
20 Years ↔
any
Population:Cisgender Men