RV 306
Status:Ongoing
Phase:II
Principal Investigator(s):Punnee Pitisuttithum, MD, DTM&H
Objective:RV306 is a double-blind, placebo-controlled, randomised clinical trial done at three clinical sites in Thailand. The primary purpose of the study is to better define the relative contributions of AIDSVAX® B/E alone, ALVAC-HIV alone, or ALVAC-HIV plus AIDSVAX® B/E combination to the observed immune profile in the weeks and months after receiving the original prime and boost vaccine regimen from study protocol RV 144, and their booster effects in both the systemic and mucosal compartments. In addition, this study will provide more intensive and comprehensive characterization of the innate, cell-mediated and humoral immune responses than possible within the RV 144 study.
Preliminary results: Results suggest that additional boosting of the RV144 regimen with longer intervals between the primary vaccination series and late boost improved immune responses and might improve the efficacy of preventing HIV acquisition.
*Analysis for trial is ongoing*
Last updated September 14, 2022
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12, 24 and 48
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionALVAC-HIV at Weeks 0 and 4; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24; AIDSVAX B/E at Week 48
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionALVAC-HIV at Weeks 0, 4 and 48; ALVAC-HIV + AIDSVAX B/E at Weeks 12 and 24
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT01931358
Trial Sponsors:
NIAID, USAMRDC
Start Date
End Date
September 1, 2013
May 1, 2021
Enrollment:367
Age range:
20 Years ↔
40 Years
Population:Cisgender Men, Cisgender Women