HIV-CORE 0052
Status:Completed
Phase:Open Label, I
Principal Investigator(s):Paola Cicconi
Objective:The object of the study is to assess the safety profile of candidate vaccines ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVcnsv4 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.tHIVconsv1, MV.tHIVconsv3 and MVA.tHIVconsv4 administered sequentially in healthy HIV-1/2 negative adult volunteers.
3 healthy, HIV-1 negative adult volunteers will receive one vaccination of low dose ChAdOx1.tHIVconsv1. A further 10 healthy, HIV-1 negative adult volunteers will receive a higher dose of ChAdOx1.tHIVconsv1, followed by one vaccination each of MVA.tHIVconsv3 and MVA.tHIVconsv4 4 weeks later.During this study, 13 individuals aged 18-65 who are in good health and are HIV-negative will be vaccinated at the CCVTM, University of Oxford. The first three participants will receive a low dose of ChAdOx1.tHIvconsv1. They will be followed up for four months, attending 7 visits in total. The remaining 10 participants will receive a higher dose of ChAdOx1.tHIVconsv1, followed one month later by one dose each of MVA.tHIVconsv3 and MVA.tHIVconsv4 (delivered separately, but at the same visit). All vaccines will be injected into the deltoid muscle of the arm; the purpose of the second vaccination is to increase the effect of the first vaccine. After the second vaccination, volunteers will be followed-up for an additional 4 months, with participants attending 12 visits over 5 months in total. Blood samples will be collected at each clinic visit for safety and analysis.
Last updated September 15, 2022
Prevention Option(s):HIV Vaccine
Study Design:Open label
Arms and Assigned Interventions
DescriptionExperimental: ChAdOx1.tHIVconsv1 low dose
3 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10^9 vp
Mode of DeliveryIntramuscular
ARMsExperimental
DescriptionExperimental: ChADOx1.tHIVconsv1 higher dose
10 participants will receive one dose of ChAdOx1.tHIVconsv1 at 5 x 10^10 vp and one dose each of MVA.tHIVconsv3 at 1 x 10^8 pfu and MVA.tHIVconsv4 at 0.9 x 10^8 pfu.
Mode of DeliveryIntramuscular
ARMsExperimental
Official Code:
NCT04586673
Trial Sponsors:
Clinical Trials and Research Governance, University of Oxford
Start Date
End Date
July 3, 2021
August 3, 2022
Enrollment:13
Age range:
18 Years ↔
65 Years
Population:Cisgender Men, Cisgender Women