NCT04586673

A Study to Assess Safety and Immunogenicity of Conserved Mosaic HIV-1 Vaccines

A Phase I Dose Escalation Open Label Trial to Assess Safety and Immunogenicity of Candidate ChAdOx1- and MVA- Vectored Conserved Mosaic HIV-1 Vaccines Given Sequentially to Healthy HIV-1 Negative Adult Volunteers in Oxford, UK

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• HIV

Interventions

Type	Name	Description
BIOLOGICAL	ChAdOx1.tHIVconsv1 (C1)	ChAdOx1.tHIVconsv1 5 x 10\^9 vp
BIOLOGICAL	ChAdOx1.tHIVconsv1 (C1)	ChAdOx1.tHIVconsv1 5 x 10\^10 vp
BIOLOGICAL	MVA.tHIVconsv3 (M3)	MVA.tHIVconsv3 1 x 10\^8 pfu
BIOLOGICAL	MVA.tHIVconsv4 (M4)	MVA.tHIVconsv4 09. x 10\^8 pfu

Timeline

• Start date: 2021-07-03
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2020-10-14
• Last updated: 2025-04-29
• Results posted: 2024-09-03

Locations

1 site across 1 country: United Kingdom