Immunotherapy In Subjects Research Articles

Clinical and Histological Clearance of VP-315: Exploratory Results of an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma

Clinical and Histological Clearance of VP-315: Exploratory Results of an Investigational Non-surgical Immunotherapy in Subjects with Biopsy Proven Basal Cell Carcinoma

Differential Transcriptome Immunomodulatory Profile of an Adjuvanted Modified Grass Immunotherapy in Subjects with Seasonal Allergic Rhinitis and Rhinoconjuctivitis

An exploratory field trial in grass allergic subjects was conducted using PQ Grass, a modified grass allergen subcutaneous immunotherapy in combination with an adjuvant system of Microcrystalline Tyrosine and Monophosphoryl Lipid A. Changes in immunomodulatory profile of PQ Grass were explored via transcriptome analysis of peripheral blood from eligible subjects.

Remission of peanut allergy is associated with rewiring of allergen-driven T helper 2-related gene networks.

The immunological changes underpinning acquisition of remission (also called sustained unresponsiveness) following food immunotherapy remain poorly defined. Limited access to effective therapies and biosamples from treatment responders has prevented progress. Probiotic peanut oral immunotherapy is highly effective at inducing remission, providing an opportunity to investigate immune changes. Using a systems biology approach, we examined gene co-expression network patterns in peanut-specific CD4+ T cell responses before and after probiotic and peanut oral immunotherapy in subjects enrolled in the PPOIT-001 randomized trial: Responders who attained remission (n=16), placebo-treated who remained allergic (n=16). Acquisition of remission was associated with rewiring of gene network patterns, which was characterized by integration of T helper 2 and interferon signalling modules, markedly reduced T helper 2gene connectivity, and shutdown in co-expression activity between T helper 2 effectors and cell cycle regulators. The immunological changes underlying remission following peanut oral immunotherapy are mediated by reprogramming of T helper 2-associated gene networks in the CD4+ T cell compartment. Findings provide insight into immune mechanisms driving the acquisition of remission following oral immunotherapy, paving the way for the development of improved approaches to induce remission/sustained unresponsiveness in patients with food allergy.

Phase I/II Trial of Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies

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Peanut Allergy: New Developments and Clinical Implications.

Food allergies have increased in prevalence over the past 20years, now becoming an important public health concern. Although there are no therapies currently available for routine clinical care, recent reports have indicated that immunotherapies targeting the mucosal immune system may be effective. Oral immunotherapy is conducted by administering small, increasing amounts of food allergen; it has shown promise for desensitizing individuals with peanut, egg, or milk allergies. Sublingual immunotherapy also desensitizes allergic patients to foods-two major studies have examined the effects of sublingual immunotherapy in subjects with peanut allergies. We review the complex nature of IgE-mediated food allergies and the therapies being evaluated in clinical trials. We focus on the diagnosis and management of food allergies and investigational therapies.

Discovery of a Selective Islet Peptidome Presented by the Highest-Risk HLA-DQ8trans Molecule.

HLA-DQ2/8 heterozygous individuals are at far greater risk for type 1 diabetes (T1D) development by expressing HLA-DQ8trans on antigen-presenting cells compared with HLA-DQ2 or -DQ8 homozygous individuals. Dendritic cells (DC) initiate and shape adaptive immune responses by presenting HLA-epitope complexes to naïve T cells. To dissect the role of HLA-DQ8trans in presenting natural islet epitopes, we analyzed the islet peptidome of HLA-DQ2, -DQ8, and -DQ2/8 by pulsing DC with preproinsulin (PPI), IA-2, and GAD65. Quality and quantity of islet epitopes presented by HLA-DQ2/8 differed from -DQ2 or -DQ8. We identified two PPI epitopes solely processed and presented by HLA-DQ2/8 DC: an HLA-DQ8trans-binding signal-sequence epitope previously identified as CD8 T-cell epitope and a second epitope that we previously identified as CD4 T-cell epitope with increased binding to HLA-DQ8trans upon posttranslational modification. IA-2 epitopes retrieved from HLA-DQ2/8 and -DQ8 DC bound to HLA-DQ8cis/trans. No GAD65 epitopes were eluted from HLA-DQ. T-cell responses were detected against the novel islet epitopes in blood from patients with T1D but scantly detected in healthy donor subjects. We report the first PPI and IA-2 natural epitopes presented by highest-risk HLA-DQ8trans. The selective processing and presentation of HLA-DQ8trans-binding islet epitopes provides insight in the mechanism of excessive genetic risk imposed by HLA-DQ2/8 heterozygosity and may assist immune monitoring of disease progression and therapeutic intervention as well as provide therapeutic targets for immunotherapy in subjects at risk for T1D.

Diagnosis, Management, and Investigational Therapies for Food Allergies

Food allergies have increased in prevalence over the past 20 years, now becoming an important public health concern. Although there are no therapies currently available for routine clinical care, recent reports have indicated that immunotherapies targeting the mucosal immune system may be effective. Oral immunotherapy is conducted by administering small, increasing amounts of food allergen; it has shown promise for desensitizing individuals with peanut, egg, or milk allergies. Sublingual immunotherapy also desensitizes allergic patients to foods-2 major studies have examined the effects of sublingual immunotherapy in subjects with peanut allergies. We review the complex nature of IgE-mediated food allergies and the therapies being evaluated in clinical trials. We focus on the diagnosis and management of food allergies and investigational therapies.

Immunological Treatments for Occupational Allergy

Although avoidance of occupational triggers remains the primary step in the management of work-related allergies, immunological treatments (including biological agents and specific immunotherapy) can be regarded as potential therapeutic options for IgE-mediated diseases; for example, many studies with allergen-specific immunotherapy have been carried out on latex allergy, showing overall favorable results, at least with sublingual immunotherapy. On the other hand, only few case reports have suggested the efficacy of immunotherapy in baker's asthma as well as in laboratory animal-induced asthma. The new technologies, including component-resolved diagnosis and recombinant allergens, are expected to improve the quality and efficacy of specific immunotherapy in the future. Also the use of omalizumab may represent a suitable therapeutic choice in very selected cases of occupational allergy, as well as an approach to reduce side effects of venom immunotherapy in subjects with previous severe reactions to the treatment.

The Efficacy of Dual Allergen Sublingual Immunotherapy in Subjects with Dermatophagoides farinae and Timothy Grass Allergy as Assessed by the Rhinoconjunctivitis Quality of Life Score

RATIONALE: We sought to evaluate the efficacy of dual allergen sublingual immunotherapy (SLIT) in subjects with Dermatophagoides farinae (DF) and Timothy Grass (TG) allergy using the Rhinoconjunctivitis Quality of Life (QOL) questionnaire.METHODS: This is a double-blind, placebo-controlled study in subjects with DF and TG allergy. Subjects were block randomized 2:1 (active drug:placebo). At the preliminary dosing visit, subjects received escalating doses of SLIT to a maximum dose. This dose was self-administered daily for 12 months. Subjects returned for follow up every 3-6 months. QOL questionnaires were administered at the preliminary visit and each follow up visit.RESULTS: Thirty subjects, age 5-57 years, were enrolled. Our preliminary data evaluates 21 subjects who have had at least 2 follow up visits. 18/21 (86%) subjects demonstrated improvement in mean QOL scores from baseline. 7/21 (33%) subjects had 50% or greater improvement in QOL scores from baseline.CONCLUSIONS: Preliminary data on subjects who received SLIT or placebo reveals that the majority showed improvement in QOL scores from baseline to first follow up visit. Given our 2:1 block randomization, a large number are likely those who received SLIT. We will further stratify our results once subjects are divided into treatment and placebo groups. To date, our data demonstrates that dual allergen SLIT is efficacious in the treatment of allergic rhinoconjunctivitis. RATIONALE: We sought to evaluate the efficacy of dual allergen sublingual immunotherapy (SLIT) in subjects with Dermatophagoides farinae (DF) and Timothy Grass (TG) allergy using the Rhinoconjunctivitis Quality of Life (QOL) questionnaire. METHODS: This is a double-blind, placebo-controlled study in subjects with DF and TG allergy. Subjects were block randomized 2:1 (active drug:placebo). At the preliminary dosing visit, subjects received escalating doses of SLIT to a maximum dose. This dose was self-administered daily for 12 months. Subjects returned for follow up every 3-6 months. QOL questionnaires were administered at the preliminary visit and each follow up visit. RESULTS: Thirty subjects, age 5-57 years, were enrolled. Our preliminary data evaluates 21 subjects who have had at least 2 follow up visits. 18/21 (86%) subjects demonstrated improvement in mean QOL scores from baseline. 7/21 (33%) subjects had 50% or greater improvement in QOL scores from baseline. CONCLUSIONS: Preliminary data on subjects who received SLIT or placebo reveals that the majority showed improvement in QOL scores from baseline to first follow up visit. Given our 2:1 block randomization, a large number are likely those who received SLIT. We will further stratify our results once subjects are divided into treatment and placebo groups. To date, our data demonstrates that dual allergen SLIT is efficacious in the treatment of allergic rhinoconjunctivitis.