NCT01024842

Safety and Immunogenicity of MVA.HIVconsv in HIV-1 Seropositive Adults on HAART

HIV-CORE 001 - A Randomised Placebo-controlled Study to Evaluate the Safety and Immunogenicity of a Candidate HIV-1 Vaccine, MVA.HIVconsv, Delivered by Intramuscular Needle Injection to HIV-1 Seropositive Adult Subjects Receiving Antiretroviral Therapy (ART).

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

In this study, the novel vaccine candidate, MVA.HIVconsv, will be tested for safety, tolerability and immunogenicity in HIV-1-seropositive subjects receiving effective antiretroviral therapy. MVA.HIVconsv will be tested as a single vaccine modality, as a prelude to testing in a heterologous viral vector boost regimen which will include a replication-defective simian adenovirus expressing the same immunogen.

Conditions

• HIV-1

Interventions

Type	Name	Description
BIOLOGICAL	MVA.HIVconsv low dose	Three intramuscular injections of MVA.HIVconsv alone at a dose of 1x10\^8 pfu at week 0, 4 and 12.
OTHER	Placebo low dose	Three intramuscular injections of placebo alone (200ul) at week 0, 4 and 12.
BIOLOGICAL	MVA.HIVconsv high dose	Three intramuscular injections of MVA.HIVconsv alone at a dose of 4x10\^8 pfu at week 0, 4 and 12.
OTHER	Placebo high dose	Three intramuscular injections of placebo alone (800ul) at week 0, 4 and 12.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2009-12-03
• Last updated: 2016-06-08

Locations

2 sites across 1 country: United Kingdom