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).

NCT01024842 Phase 1 TERMINATED

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.

Details

Lead sponsor	University of Oxford
Phase	Phase 1
Status	TERMINATED
Enrolment	19
Start date	2009-12
Completion	2013-11

Conditions

• HIV-1

Interventions

• MVA.HIVconsv low dose
• Placebo low dose
• MVA.HIVconsv high dose
• Placebo high dose

Primary outcomes

• The proportion of volunteers who develop a grade 3 or 4 local or systemic reactions — Actively collected data throughout the study until 6 months after the last vaccination

Countries

United Kingdom