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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
13
ChAdOx1.tHIVconsv1 5 x 10\^9 vp
ChAdOx1.tHIVconsv1 5 x 10\^10 vp
MVA.tHIVconsv3 1 x 10\^8 pfu
MVA.tHIVconsv4 09. x 10\^8 pfu
Centre for Clinical Vaccinology and Tropical Medicine, Churchill Hospital
Oxford, United Kingdom
Assessement of Safety
• Proportion of volunteers with vaccine related serious adverse events (SAEs) collected up to day 140 after enrollment.
Time frame: 140 days
Assement of Safety
Proportion of volunteers with Grade 3 or 4 unsolicited adverse events (AEs) through 28 days post final vaccination
Time frame: up to 28 days after each vaccination
Assessment of Safety
Proportion of volunteers with local and systemic reactogenicity events from Day 0 to Day 6 post vaccination
Time frame: up to day 7
Assessment of the Immunogenicity of the ChAdOx1.tHIVconsv1 and MVA.tHIVconsv3 & 4 Vaccines Administered Sequentially.
The proportion of participants that develop T-cell responses to tHIVconsvx measured by IFN-gamma ELISpot assay
Time frame: Up to 5 months
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