An Open Phase I/IIa Study to Evaluate the Safety and Effect of Therapeutic HIV-1 Immunization Using Vacc-4x + rhuGM-CSF and HIV-1 Reactivation Using Romidepsin on the Viral Reservoir in Virologically Suppressed HIV-1 Infected Adults on cART

The REDUC trial's objective is to address one of the core issues with the treatment of HIV, which is that some HIV infected cells hide in so-called latent reservoirs. The reservoirs are unaffected by conventional HIV medication and invisible to the immune system. HDACi have the potential to activate these latently infected cells. This will make the HIV infected cells visible to the immune system; the immune response generate by Vacc-4x will be able to attack and eliminate the infected cells.

Start Date01 Mar 2014

Sponsor / Collaborator

Bionor Immuno AS

[+1]

EUCTR2012-002281-12-DE / Not yet recruitingNot Applicable

Re-boosting of Subjects Previously Included in the CT BI-Vacc-4x 2007/1 Study. An Open, Multicenter, Immunogenicity, Follow-up Reboosting Study with Vacc-4x in Subjects Infected with HIV-1 Who Have Maintained an Adequate Response to ART

Start Date01 Feb 2013

Sponsor / Collaborator

Bionor Immuno AS

EUCTR2012-002281-12-IT / Not yet recruitingNot Applicable

Start Date14 Dec 2012

Sponsor / Collaborator

Bionor Immuno AS

100 Clinical Results associated with Bionor Immuno AS

0 Patents (Medical) associated with Bionor Immuno AS

Literatures (Medical) associated with Bionor Immuno AS

31 Jul 2018·AIDS

Differences in antiretroviral regimens do not impact safety or level of latency reversal in persons receiving romidepsin

Letter

Author: Søgaard, Ole S ; Tolstrup, Martin ; Østergaard, Lars ; Sommerfelt, Maja ; Leth, Steffen ; Jørgensen, Sofie

01 Mar 2018·AIDS Research and Human RetrovirusesQ4 · MEDICINE

Postvaccination C-Reactive Protein and C5/gp41^732–744Antibody Level Fold-Changes Over Baseline Are Independent Predictors of Therapeutic HIV Vaccine Effect in a Phase 2 Clinical Study of Vacc-4x

Q4 · MEDICINE

Article

Author: Sommerfelt, Maja A. ; Jelmert, Øyvind ; Sanchez, Brittany ; Stjernholm, Grete ; Zhang, Lily ; Huang, Yunda ; Jolliffe, Darren ; Ökvist, Mats

Therapeutic vaccination has the potential to contribute to functional HIV cure strategies. However, to show functional HIV cure, study participants must be taken off combination antiretroviral therapy (cART). The availability of suitable biomarkers that can predict viral load (VL) or CD4 count outcomes following therapeutic HIV vaccination would reduce the risks associated with cART interruption in such studies. This report sought to determine baseline and postvaccination biomarker predictors of vaccine effect (VE) on VL and CD4 counts following cART interruption in a double-blind, randomized phase 2 study of the peptide-based therapeutic HIV vaccine, Vacc-4x (n = 93), versus placebo (n = 43). Antibody responses to a novel envelope glycoprotein antigen, C5/gp41^732-744, and three safety marker measurements [C-reactive protein (CRP), white blood cell, and lactate dehydrogenase] were considered. Interaction tests in univariate and multivariate linear regression models were used to estimate the effect of biomarkers on VE, defined as the VL or CD4 count difference in Vacc-4x versus placebo groups. The reported q-values (considered significant for hypothesis-generating purposes if ≤0.2) accounted for multiple comparisons using the false discovery rate method. Data were analyzed from all available 58 Vacc-4x and 25 placebo recipients before cART resumption. Lower postvaccination fold-change over baseline of CRP concentration (interaction p- (q-) value = 0.005 (0.11) for VL) and higher fold-change of anti-C5/gp41^732-744 antibody levels (0.005 (0.11) for VL and 0.009 (0.20) for CD4) were associated with Vacc-4x benefit. These findings suggest potential roles for inflammation and immune activation markers in predicting therapeutic HIV VE.

01 Dec 2017·Journal of InfectionQ2 · MEDICINE

Sequential Vacc-4x and romidepsin during combination antiretroviral therapy (cART): Immune responses to Vacc-4x regions on p24 and changes in HIV reservoirs

Q2 · MEDICINE

Article

Author: Leth, S ; VanBelzen, D J ; Tolstrup, M ; Ökvist, M ; Nissen, S K ; Tapia, G ; Sommerfelt, M A ; Østergaard, L ; Krogsgaard, K ; Højen, J F ; Mørk, A ; Pantaleo, G ; Søgaard, O S ; O'Doherty, U ; Olesen, R

OBJECTIVESThe REDUC clinical study Part B investigated Vacc-4x/rhuGM-CSF therapeutic vaccination prior to HIV latency reversal using romidepsin. The main finding was a statistically significant reduction from baseline in viral reservoir measurements. Here we evaluated HIV-specific functional T-cell responses following Vacc-4x/rhuGM-CSF immunotherapy in relation to virological outcomes on the HIV reservoir.METHODSThis study, conducted in Aarhus, Denmark, enrolled participants (n = 20) with CD4>500 cells/mm³ on cART. Six Vacc-4x (1.2 mg) intradermal immunizations using rhuGM-CSF (60 μg) as adjuvant were followed by 3 weekly intravenous infusions of romidepsin (5 mg/m²). Immune responses were determined by IFN-γ ELISpot, T-cell proliferation to p24 15-mer peptides covering the Vacc-4x region, intracellular cytokine staining (ICS) to the entire HIV^Gag and viral inhibition.RESULTSThe frequency of participants with CD8+ T-cell proliferation assay positivity was 8/16 (50%) at baseline, 11/15 (73%) post-vaccination, 6/14 (43%) during romidepsin, and 9/15 (60%)post-romidepsin. Participants with CD8+ T-cell proliferation assay positivity post-vaccination showed reductions in total HIV DNA post-vaccination (p = 0.006; q = 0.183), post-latency reversal (p = 0.005; q = 0.183), and CA-RNA reductions post-vaccination (p = 0.015; q = 0.254). Participants (40%) were defined as proliferation 'Responders' having ≥2-fold increase in assay positivity post-baseline. Robust ELISpot baseline responses were found in 87.5% participants. No significant changes were observed in the proportion of polyfunctional CD8+ T-cells to HIV^Gag by ICS. There was a trend towards increased viral inhibition from baseline to post-vaccination (p = 0.08).CONCLUSIONSIn this 'shock and kill' approach supported by therapeutic vaccination, CD8+ T-cell proliferation represents a valuable means to monitor functional immune responses as part of the path towards functional HIV cure.

100 Deals associated with Bionor Immuno AS

100 Translational Medicine associated with Bionor Immuno AS

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Drug(Targets)	Indications	Global Highest Phase

Vacc-C5 ( HIV envelope protein gp120 )	HIV Infections More	Pending
Romidepsin ( HDACs )	HIV Infections More	Pending
HIV vaccine Vacc-4x(Bionor Immuno AS)	HIV Infections More	Pending

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