HVTN 097

Status:Completed
Phase:I
Principal Investigator(s):
Objective:To evaluate ALVAC and AIDSVAX B/E, tetanus toxoid vaccine and hepatitis B vaccine. Last updated March 24, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Placebo, Randomized
Arms and Assigned Interventions
DescriptionParticipants will receive a tetanus vaccine injection (tetanus toxoid vaccine), followed by 2 injection of an experimental canarypox HIV vaccine (ALVAC-HIV; months 1, 2), than 2 injection of a protein HIV vaccine boost (AIDSVAX B/E; months 4, 7), followed by a hepatitis B vaccine series (months 7.5, 8.5, 13)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive a placebo for tetanus vaccine by injection (placebo tetanus toxoid vaccine), followed by 2 injection of an experimental canarypox HIV vaccine (ALVAC-HIV; months 1, 2), than 2 injection of a protein HIV vaccine boost (AIDSVAX B/E; months 4, 7), followed by a placebo for hepatitis B vaccine series (months 7.5, 8.5, 13)
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionParticipants will receive a tetanus vaccine injection (tetanus toxoid vaccine), followed by 2 injection of a placebo for the experimental canarypox HIV vaccine (placebo for ALVAC-HIV; months 1, 2), than 2 injection of a placebo protein HIV vaccine boost (placebo for AIDSVAX B/E; months 4, 7), followed by a hepatitis B vaccine series (months 7.5, 8.5, 13)
Mode of DeliveryIntramuscular
ARMsPlacebo Comparator
Results: Landscapes of binding antibody and T-cell responses to pox-protein HIV vaccines in Thais and South Africans
Official Code: NCT02109354
Related Publications:
Uptake of genital mucosal sampling in HVTN 097, a phase 1b HIV vaccine trial in South Africa
Trial Sponsors: HVTN
Start Date
End Date
June 18, 2013
February 3, 2015
Enrollment:202
Age range: 18 Years ↔ 40 Years
Population:Cisgender Men, Cisgender Women