HIV-CORE 0051
Status:Completed
Phase:Open Label, I/II
Principal Investigator(s):Paola Cicconi
Objective:Researchers at the University of Oxford in collaboration with colleagues at Irsicaixa in Barcelona and industry partners have developed novel candidate vaccines against HIV (HTI). These have been inserted into chimpanzee adenovirus (ChAd) and modified vaccinia virus Ankara (MVA) backbones, both of which have excellent safety records. The aims of this Horizon 2020 funded study are to see if these vaccine candidates are safe, well tolerated and induce an immune response against HIV infection.The primary object of the study is to assess the safety profile of candidate vaccines ChAdOx1.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult volunteers.
In addition, the study will assess the immune responses generated of the candidate vaccines ChAdOx1.HTI and MVA.HTI administered sequentially in healthy HIV-1/2 negative adult volunteers.
10 healthy, HIV-negative adult volunteers will receive one vaccination of CHAdOx1.HTI followed by a one vaccination of MVA.HTI 8 weeks later. Last updated September 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Arms and Assigned Interventions
DescriptionExperimental: ChAdOx1.HTI and MVA.HTI vaccination
1x dose of ChAdOx1.HTI at 5 x 10^10 vp
1x dose of MVA.HTI at 2 x 10^8 pfu
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT04563377
Trial Sponsors:
Clinical Trials and Research Governance, University of Oxford
Start Date
End Date
November 1, 2021
August 16, 2022
Enrollment:10
Age range:
18 Years ↔
65 Years
Population:Cisgender Men