Immunotherapy With Vacc-C5 With Adjuvant GM-CSF or Alhydrogel in HIV-1-infected Subjects on ART

Summary

Background: Despite the introduction of highly effective antiretroviral therapy (ART) regimes, which control the HIV infection and results in increases in CD4 cell counts and an undetectable viral load, many patients suffer from increased morbidity. There is evidence that presence of antibodies against the C5 region of gp120 strongly correlates with slower disease progression, and that loss of antibody responses to this region are associated with progression. Investigational product: Vacc-C5 is a single heterodimeric peptide-based HIV therapeutic vaccine corresponding to the C5 region on gp120 and the external domain of gp41. The vaccine is intended to create a non-neutralizing antibody against C5 region. Study objectives: 1. To evaluate safety of the vaccination regimens 2. To evaluate C5-specific humoral immune responses (antibodies), T cell responses, T cell activation markers and other immune markers.

Timeline

Start

2012-09

Primary completion

2013-11

Completion

2013-11

Outcome

Met primary endpoint

release “trial of Vacc-C5. The trial met its primary endpoint which was safety.” bionorholding.com ↗

Publications

• Brekke K, Sommerfelt M, Okvist M, Dyrhol-Riise AM, Kvale D. The therapeutic HIV Env C5/gp41 vaccine candidate Vacc-C5 induces specific T cell regulation in a phase I/II clinical study. BMC Infect Dis. 2017 Mar 24;17(1):228. doi: 10.1186/s12879-017-2316-x.

Drugs

Indications