A Phase I/IIa Clinical Trial of HIV-1 Vaccines pSG2.HIVconsv DNA, MVA.HIVconsv and Ad35-GRIN in Combined Regimens in Healthy HIV-1/2-negative Adults in Nairobi. (HIV-CORE 004)

NCT02099994 Phase 1/Phase 2 COMPLETED

The study is part of a long-term aim to develop an effective HIV-1 vaccine and will evaluate safety and immunogenicity of vaccines focusing T cell responses on the conserved region of the HIV-1 proteome. The vaccines used are pSG2.HIVconsv DNA (D), MVA.HIVconsv (M) and Ad35-GRIN (A), delivered in regimens AM, DDDAM and DeDeDeAM, where e indicates electroporation.

Details

Lead sponsor	University of Oxford
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	72
Start date	2014-03
Completion	2015-08

Conditions

• AIDS

Interventions

• Ad35-GRIN
• MVA.HIVconsv
• pSG2.HIVconsv DNA
• Electroporated pSG2.HIVconsv

Primary outcomes

• Vaccine Safety — 44 weeks
  Proportion of volunteers who develop a grade 3 or 4 local reaction. Proportion of volunteers who develop a grade 3 or 4 systemic reaction

Countries

Kenya