TAMOVAC-02

Status:Completed
Phase:II
Principal Investigator(s):Ilesh Jani, MD, PhD; Muhammad Bakari, MD, MMED, PhD; Leonard Maboko, MD, MSc
Objective:Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.   Last updated March 31, 2021
Prevention Option(s):HIV Vaccine
Study Design:Controlled, Double-blind, Randomized
Arms and Assigned Interventions
DescriptionThis arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml
Mode of Delivery
ARMsExperimental
DescriptionThis arm will receive 600 micrograms of HIVIS DNA given as 2 injections using the Zetajet device each injection will comprise of 0.1 ml at a concentration of 3mg/ml followed by electroporation using the Derma Vax device.
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionThis arm will receive 600 micrograms of HIVIS DNA given in 1 injection using the Zetajet device the injection will comprise of 0.1 ml at a concentration of 6mg/ml followed by electroporation using the Derma Vax device.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code: NCT01697007
Related Publications:
Regulatory T cell abundance and activation status before and after priming with HIVIS-DNA and boosting with MVA-HIV/rgp140/GLA-AF may impact the magnitude of the vaccine-induced immune responses
Trial Sponsors: Muhimbili University of Health and Allied Sciences
Start Date
End Date
November 1, 2012
July 1, 2015
Enrollment:198
Age range: 18 Years ↔ 40 Years
Population:Cisgender Men, Cisgender Women