NCAIDS X111012202

Status:Completed
Phase:II
Principal Investigator(s):Hao Wu, MD; Tong Zhang, MD; Yiming Shao, PhD;
Objective:Studies the safety and immunogenicity of a HIV clade B'/C DNA vaccine followed by recombinant vaccinia virus rTV boost in HIV-uninfected healthy volunteers at low or high risk of HIV infection. In addition, the effect of different intervals of the prime-boost will be studied.
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionDNA vaccine prime at week 0,4,8 and rTV boost at week 16
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionDNA vaccine prime at week 0,4,8 and rTV boost at week 24
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionDNA vaccine prime at week 0,4,8 and rTV boost at week 32
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionDNA vaccine prime with the addition of electroporation at week 0, 4, 8 and rTV boost at week 24
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01705223
Trial Sponsors: China CDC & National Vaccine and Serum Institute, National Center for AIDS/STD Control and Prevention
Start Date
End Date
August 1, 2012
December 31, 2014
Enrollment:150
Age range: 18 Years ↔ 55 Years
Population:Cisgender Men, Cisgender Women