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PubMed2002

Allergen-immunostimulatory oligodeoxynucleotide conjugate: a novel allergoid for immunotherapy.

PURPOSE OF REVIEW: To summarize the data of both preclinical studies and initial clinical trials of a novel allergoid for allergen specific immunotherapy. This allergoid consists of allergen covalently coupled to immunostimulatory oligodeoxynucleotide DNA sequences. RECENT FINDINGS: Recently, immunostimulatory oligodeoxynucleotide sequences, also called unmethylated cytosin-guanine dinucleotide motifs, have been discovered that act as strong T helper 1 response inducing adjuvants in mice. Although mixing allergens with immunostimulatory DNA sequences induces T helper 1 responses in T helper 2 biased mice, the allergens in such mixes could still cause anaphylactic reactions when used in humans which is one of the reasons why immunotherapy has gradually been falling out of favor. Therefore, we made allergen-immunostimulatory oligodeoxynucleotide conjugates and investigated their immunogenicity and allergenicity in animal models of allergy. These conjugates were highly immunogenic for inducing T helper 1-like antiallergen responses and reversed T helper 2 responses and symptoms of asthma in mouse models. They were also less allergenic, as shown by the reaction with human immunoglobulin E antibodies and by histamine release from basophils of allergic patients. Preliminary phase I and II trials in ragweed allergic patients showed that allergen-immunostimulatory oligodeoxynucleotide conjugates are well tolerated, less allergenic and induce immunoglobulin G antiallergen antibodies more rapidly than allergen extracts without significantly increasing the immunoglobulin E titer. SUMMARY: Allergen-immunostimulatory DNA conjugates induce T helper 1 and down regulate preexisting T helper 2 anti-allergen responses in mice. Initial phase I and II trials in ragweed allergic patients showed that ragweed allergen-DNA conjugates are well tolerated and induce a rapid immunoglobulin G but not E response. The data show that allergen-DNA conjugates are a novel type of allergoid that have great potential for a safe and potent form of allergen specific immunotherapy.

Adjuvants, Immunologic↗

PubMed1997

Immunotherapy with an alum-adsorbed Parietaria-pollen allergoid: a 2-year, double-blind, placebo-controlled study.

A double-blind, placebo-controlled study was performed in order to confirm the safety, suitability, and efficacy of an alum-adsorbed Parietaria judaica-pollen allergoid, Allergovit, for allergen-specific immunotherapy. Parietaria pollen is an important cause of pollinosis, particularly in the Mediterranean zone, where it may be encountered for up to 8-9 months of the year. It is an aggressive allergen, and the doses tolerated during immunotherapy are less than those achieved with grass pollen. This factor increases the desirability of using therapeutic preparations with minimal IgE-binding activity, such as allergoids, in order to reduce the risk of side-effects and enable patients to tolerate a higher dose of allergen, thereby increasing the chances of successful specific immunotherapy. Forty patients with rhinitis and/or asthma were allocated at random to active- or placebo-treatment groups at the beginning of the study. All patients received the active preparation during the second year of the study. Immunotherapy was well tolerated by all patients and the incidence of side-effects was low. Treatment resulted in significant reductions in specific cutaneous reactivity and increases in nasal tolerance. A progressive improvement in nasal inspiratory peak flow in association with the immunotherapy indicated a reduction in nasal inflammation. These objective assessments of efficacy endorsed the results from the patients' diary cards, which indicated significant improvements in symptoms and reductions in the use of medication. The immunologic activity of the therapeutic preparation was demonstrated by the induction of a significant specific-IgG antibody response, with increases in IgG4 during the second year of treatment. We conclude that the safety and efficacy of immunotherapy with the Parietaria allergoid make it suitable for consideration in the treatment of patients with Parietaria-pollen-induced rhinitis or asthma.

Adolescent↗

PubMedDate not supplied

Efficacy and tolerability of short-term specific immunotherapy with pollen allergoids adjuvanted by monophosphoryl lipid A (MPL) for children and adolescents.

BACKGROUND: Specific immunotherapy (SIT) with pollen allergoids formulated with the Th1-inducing adjuvant 3-deacylated monophosphoryl lipid A (MPL adjuvant, Corixa) has shown good efficacy and tolerability in the treatment of pollen allergies in adults. The aim of this study was to evaluate this treatment in children and adolescents aged 6-17 years old who were sensitive to grass/rye or tree pollens. METHODS: An open, multicenter study was performed using 90 children and adolescents. The patients received four subcutaneous injections of grass/rye (n = 64) or tree pollen allergoids (n = 26) adsorbed to L-tyrosine and containing MPL adjuvant. Efficacy was measured by symptom and medication scoring, skin prick test reactivity and IgG/IgE antibody responses. Tolerability was monitored by recording adverse events. RESULTS: Both grass/rye and tree pollen treatment groups showed significant reductions in symptom scores and anti-allergic medication use compared with the previous pollen seasons (p < 0.01 in all cases). After therapy, skin prick test reactivity was significantly reduced in both groups and pollen-specific IgG was significantly increased in both groups whereas little change was apparent in pollen-specific IgE. Overall tolerability was similar to results obtained in previous studies in adults. CONCLUSION: Short-term SIT using four injections of grass/rye or tree pollen allergoids adsorbed to L-tyrosine and with MPL adjuvant was shown to be effective with good tolerability. The treatment compared favorably with previous studies in adults.

Adjuvants, Immunologic↗

PubMed2000

Preseasonal local allergoid immunotherapy to grass pollen in children: a double-blind, placebo-controlled, randomized trial.

BACKGROUND: We assessed the efficacy of preseasonal local allergoid immunotherapy in a group of children with asthma and/or rhinitis and/or rhinoconjunctivitis due to grass pollen. METHODS: We randomly assigned 24 children allergic to grass pollen to receive local allergoid immunotherapy for 3 months before the pollen season and 24 such patients to receive identically appearing placebo. The immunotherapy consisted of tablets of monomeric allergoid grass pollen allergens held in the mouth until they dissolved and then swallowed. The study was double-blind. Symptoms and medications were scored on diary cards during the pollen season. Nasal eosinophil cationic protein levels were measured by the monoclonal antibodies EG1 and EG2 outside the pollen season and at low and at high pollen concentration during the pollen season. RESULTS: The active-treatment group had a statistically significant reduction of total symptoms (P<0.05), especially bronchial symptoms (P<0.05), in comparison with the placebo group. Immunotherapy was well tolerated and compliance was good. Nasal levels of EG2 and EG1 increased significantly during the pollen season, but there was no difference between groups. EG2/EG1 increased significantly only in the placebo group during natural allergen exposure (P<0.01). CONCLUSIONS: Our results suggest that this immunotherapy is effective for the treatment of asthma due to grass pollen in children.

Administration, Oral↗

PubMed1992

[A comparative immunochemical analysis of allergoids and allergens].

In comparison with allergens having protein fragments with a molecular weight not exceeding 110 kD, allergoids have been found to consist of larger fragments with a molecular weight of 10-150 kD. Allergoids have less charged components than initial allergens and less antigenic components. Allergoids retain their capacity for stimulating the production of antibodies, specific to all antigenic components.

Allergens↗

PubMed1986

Specific immunotherapy with allergoids in atopic subjects, hyporeactive to other vaccines.

Allergoids comply with the therapeutic requirement to reach high doses of the injected allergen, since the modifications of the allergens cause a loss of allergenicity, though the immunogenicity is being retained. Considering that it is possible to use a starting dose 40 times higher in comparison with retard vaccines, we thought it very expedient to treat with allergoids 18 patients allergic to parietaria, and 12 patients allergic to grass pollen, who had shown no clinical improvement after immunotherapy, lasting for at least three years with retard vaccines. The therapeutic results obtained are the following: improvement in 66% of the parietaria allergic patients after the first year, and of the 72% in the second year, of the 75% of the grass pollen allergic patients after the first year and of the 83% in the second year. They can be interpreted as due to the fact that such patients are always poorly reactive to the doses of allergens commonly present in retard vaccines. On the contrary, they do react to allergoids, both due to the high amount of allergen administered, and to the fact that polymerization brings about a stronger epitopic expression matched by a higher immunogenic activity. Moreover, the data are also indicative for a good relationship between the antibody titer of antigen-specific blocking IgG and the clinical effectiveness valued by means of symptom and medication scores.

Humans↗

PubMed1999

Long-term treatment with allergoid immunotherapy with Parietaria. Clinical and immunologic effects in a randomized, controlled trial.

BACKGROUND: Specific immunotherapy (SIT) is a valuable treatment for respiratory allergy, and the use of chemically modified allergens (allergoids) has improved its safety, as testified by several studies. We evaluated the effects of a SIT course with an allergoid extract of Parietaria pollen in a double-blind, placebo-controlled trial. METHODS: The study was double-blind in the first year; then it was prolonged up to 3 years with all patients on active treatment. Clinical effectiveness, safety, skin reactivity, systemic immunologic parameters, and subjective assessment were evaluated. We also had available a self-evaluation recorded in a follow-up visit 4 years after the discontinuation of SIT. RESULTS: A significant reduction of the symptoms plus drug intake scores during the pollen seasons was observed in the patients receiving active SIT. The placebo patients, after switching to active SIT, also showed significant clinical improvement. The clinical efficacy persisted during years 2 and 3 of treatment. After year 1, the actively treated patients reported a significant subjective improvement (frequency of symptoms, P = 0.001; duration of symptoms, P = 0.024; physical performance, P = 0.043) compared with the placebo group. The self-evaluation by visual analog scale showed that all patients maintained a significant clinical improvement up to 4 years after discontinuing SIT (year 1: active=+31.6%, placebo=-15.7%; year 7: active=+35.8%, placebo=+31.3%). The systemic immunologic changes after active SIT paralleled those described elsewhere (IgE decreased from 22 to 9 and from 21 to 8 IU/ml; IgG4 increased from 43 to 87 and from 18 to 60 IU/ml). A significant decrease in skin reactivity to three different allergen concentrations was observed at year 3 compared with pretreatment values (P<0.05). CONCLUSIONS: The investigational SIT with Parietaria appeared to be effective and safe; a 3-year course of treatment achieved a long-lasting efficacy.

Adolescent↗

PubMed2006

Safety, tolerability and efficacy of sublingual allergoid immunotherapy with a 4-day shortened build-up phase.

BACKGROUND: Sublingual specific immunotherapy (SLIT) with monomeric allergoid has shown to be safe and effective the studies performed so far. The build-up phase, however, is rather time consuming mainly if performed with the conventional schedule of 14 weeks. AIMS OF STUDY: We evaluated the possibility of shortening and simplifying this phase, through a new build-up scheme of only 4 days, as well as the persistence of the allergoid SLIT efficacy after 12 months. METHODS: Thirty-nine patients (26 M, 13 F, mean age 20.5 years, range 6-49) with a history of moderate/severe rhinitis with or without mild asthma due to perennial and/or seasonal allergens entered the study. The posological schedule, adopting only 1,000 AU tablets, was the following: 1/2 tablet the 1st day; 1/2 table twice the second day; 1/2 table plus 1 table the 3rd day, 1 tablet twice the 4th day; 1 tablet twice weekly from the 5th to the 365th day (maintenance therapy). RESULTS: Only two mild adverse reactions occurred during the initial phase which disappeared with the prosecution of the treatment. During the maintenance therapy no adverse event was observed. Symptoms improved consistently and drug consumption was reduced in most of the patients. CONCLUSIONS: The 4-day shortened build-up phase resulted to be safe, well tolerated and effective, already after one year of treatment.

Administration, Sublingual↗

PubMed1986

The clinical and immunologic efficacy of immunotherapy with modified ragweed extract (allergoid) for ragweed hay fever.

A double-blind study comparing formaldahyde modified ragweed allergen (allergoid) and placebo in the treatment of allergic rhinitis was carried out. Twenty ragweed-sensitive patients were studied, ten receiving 10,710 PNU of allergoid pre-seasonally and ten receiving placebo injections. Daily symptom score sheets were kept by each patient during August and September of 1983. A significant difference in average daily symptom scores (P = 0.01) between the two groups was noted. Significant differences were also observed in symptom scores for individual weeks during the ragweed season. Post-treatment allergen-specific IgG blocking antibody was significantly higher (P = 0.001) in the treatment group compared to pre-treatment levels and when compared to the control group (P = 0.01). No significant local or systemic reactions occurred. The results suggest that the dosage protocol used in this study is appropriate as an initial treatment schedule in clinical practice.

Adult↗

PubMed1980

[Antigenic properties of the allergoid from ragweed pollen].

It was shown that allergoid, a preparation with decreased allergenicity and preserved immunogenicity, can be produced from ragweed growing in Stavropol. A comparative study of variations in the antigenic properties of the allergen under the effect of the temperature factor alone or a combination of the latter with formaldehyde allowed a conclusion that formaldehyde selectively neutralizes the antigenic determinants responsible for allergenicity. At the same time allergoid preserves its ability to induce antibody specific for the initial allergen in the rabbit.

Allergens↗

PubMed1993

[The mite allergen and allergoid stimulation of histamine secretion by mast cells].

Rat peritoneal mast cells were incubated with serum from highly mite-sensitive patients. It was demonstrated that exposure of passive sensitized mast cells to allergen from mites Dermatophagoides farinae induced the release of histamine. Exposure of mast cells to 10 micrograms/ml and 50 micrograms/ml mite allergen resulted in an increase of histamine secretion to 48% of the basal level. The allergoid (formaldehyde-modified mite allergen) had poor histamine-releasing activity compared to allergen. The allergoid (50 micrograms/ml) induced a 2.5-fold decrease in histamine release. The allergen at the same concentrations and the same release as allergen in dose 0.1 microgram/ml.

Allergens↗

PubMedDate not supplied

Linear monitoring of patients sensitive to Olea and grass pollens treated with immunotherapy based on glutaraldehyde-modified (allergoid) extracts.

Extracts modified with glutaraldehyde (allergoid) have been offered to allergologists for immunotherapy in the last few years as supposedly clinically effective agents that diminish undesirable side-effects (allergenicity vs. immunogenicity). In order to acquire experience in the use of this therapeutic resource, we monitored a group of patients with pollinosis sensitive to Olea, grass pollens or both, who suffered from seasonal rhinoconjunctivitis (SRC) or rhinoconjunctivitis and seasonal asthma (RCSA) and were administered allergoid treatments standardized in biological units (HEP). The patients were monitored by determination of specific IgE and IgG4, endpoint prick tests and conjunctival provocation tests (CPT) with two types of antigen: Lolium perenne and Olea europaea. Measurements were made at baseline (T1), when the maximal tolerated dose had been given (T2) and 1 year after the treatment was started (T3). According to our results, this type of extract is tolerated quite well and causes no alterations in specific IgG4 or IgE levels. On the other hand, it features significantly decreased allergen-specific skin reactivity and increased response thresholds to the CPT (p < 0.01). A high correlation between skin and conjunctival provocation tests was observed at some stages (r = 0.79, p < 0.01).

Adult↗

PubMedDate not supplied

Single-course specific immunotherapy with mixed pollen allergoids: results of a multi-centre study.

BACKGROUND: A short-term immunotherapy vaccine for the treatment of pollen allergy has been developed utilising L-tyrosine adsorbed allergoids. The reduced number of injections could provide advantages over long-term therapy schedules. This would improve compliance and support application of specific immunotherapy (SIT) to a greater extent. We report a multicenter study to evaluate the efficacy and safety of this treatment in a clinical practice setting. METHODS: Patients (n = 1808) with a diagnosis of sensitivities to various pollens and symptoms of allergic asthma and/or allergic rhinitis and/or allergic conjunctivitis were selected. The vaccine formulation was made up according to individual sensitivities and contained L-tyrosine adsorbed allergoids. The patients were treated with a 3-injection initial course followed by a 3-injection maintenance course. Efficacy was measured by consumption of symptomatic anti-allergic medication compared with that in the previous season and by physician assessment using a 5-point scale. All adverse events were recorded. RESULTS: Efficacy was demonstrated by a considerable decrease in regular and frequent use of medication compared with that in the previous season (p < 0.001). In addition, in 80 % of the patients, the physician's assessment was either "good" or "very good". These outcomes were unaffected by the closeness of the treatment course to the onset of the pollen season. Tolerability was good and most local and systemic reactions were mild. CONCLUSIONS: The treatment of pollen-allergic patients with a short-term SIT using a 6-injection pollen allergoid/L-tyrosine vaccine in a clinical practice setting provided a high level of efficacy with a low incidence of mainly mild adverse events.

Adolescent↗

PubMedDate not supplied

[Advantages of hyposensitization with a high dose of allergoid in pollen allergy].

Grass and rye pollen sensitive children were hyposensitized with glutaraldehyde-modified, tyrosine-adsorbed grass and rye allergoid. We evaluated the clinical efficacy and immunological changes associated with the administration of 3100 NOON-Units (NU) with 3 injections in 15 patients (group A) and 9100 NU with 6 injections in 13 patients (group B) preseasonally. No systemic side effects during therapy were observed. In patient's assessments, a clinical improvement was reported; however, group B achieved better symptom and medication scores. The latter group obtained slightly higher specific IgG levels than group A after two seasons of treatment, whereas the co-seasonal increase of specific IgE was higher in group A. Hyposensitization with grass and rye allergoid is a safe therapy, a better clinical and immunological effect being observed in a high dose regimen.

Child↗

PubMed1992

Clinical and immunological effects of immunotherapy with alum-absorbed grass allergoid in grass-pollen-induced hay fever.

A double-blind, placebo-controlled study of immunotherapy was conducted in 19 patients with grass-pollen hay fever to evaluate the efficacy and safety of a formalinized depot grass allergoid. The patients were assessed before and during IT by clinical (symptom-medication scores during the grass- pollen season, specific nasal and skin reactivity) and immunological (specific IgE, IgG, IgG1 and IgG4 antibodies) parameters. High doses of grass allergoid, corresponding to a cumulative pre-seasonal dosage of 46,050 PNU, were administered, with only one systemic reaction. The actively treated patients had significantly lower symptom-medication scores than placebo (p less than 0.01) during the month of May and showed a significant decrease in specific skin (p less than 0.01) and nasal (p less than 0.05) reactivity, and a significant early increase in specific IgE (p less than 0.01), IgG (p less than 0.0005), IgG1 (p less than 0.001) and IgG4 (p less than 0.05), with a subsequent decrease of IgE and IgG1. No differences were detected in any of these parameters in the placebo group. A correlation was found between high IgG4/IgG1 ratio and the specific skin reactivity decrease (r = 0.691, p less than 0.05), whereas a high IgG4/IgG1 ratio was associated with higher symptom-medication scores (r = 0.654, p less than 0.05). Possible explanations of these apparent discrepancies are proposed.

Adolescent↗

PubMed1982

Studies of allergen and allergoid preparations from purified timothy (Phleum pratense) pollen extracts. I. Physicochemical characteristics and binding to allergen-specific human IgE.

Physicochemical and in vitro allergenic properties of two different preparations of timothy (Phleum pratense) pollen were compared. The refined allergen extract, timothy B, contained proteins of molecular weights from 10,000 to 45,000 daltons. The allergoid preparation, which was prepared by mild treatment of the partially purified extract with formaldehyde, possessed only a trace of activity in the RAST inhibition assay. The formaldehyde treatment also resulted in a shift of the net charge of proteins to the more acidic site, as demonstrated by isoelectric focusing. Furthermore, it was shown that the activities of naturally occurring enzymes of native allergen extracts were reduced considerably. Only traces of acid phosphatase activity could be demonstrated in timothy B allergoid.

Acid Phosphatase↗

PubMed1986

Specific IgE response before and after rush immunotherapy with a standardized allergen or allergoid in grass pollen allergy.

Allergen extracts contain a wide variety of allergenic determinants and the sensitization of allergic subjects is extremely heterogeneous. Specific immunotherapy is usually performed with multiple component extracts and it is therefore important to determine whether this treatment may elicit the onset of newly developed IgE sensitivities. By means of nitrocellulose immunoblotting technique, the IgE sensitivities of 20 patients were characterized before and after specific immunotherapy. Ten patients had a rush immunotherapy with a standardized orchard grass pollen extract and ten others underwent a rush immunotherapy with a 6-grass pollen allergoid. The allergenic profiles of the patients before and after immunotherapy were qualitatively similar. In some patients an increase of orchard grass pollen-specific IgE was observed and the allergenic profile was quantitatively different. These results suggest that rush immunotherapy with either an aqueous non-modified extract or an allergoid does not elicit the onset of new IgE sensitivities. Multicomponent allergenic extracts may therefore be used in the treatment of patients.

Adolescent↗

PubMed1980

Prevention of allergoid (cutaneous anaphylactoid) reactions to polygeline (Haemaccel) in orthopaedic patients by premedication with H1- and H2-receptor antagonists.

"Purified" polygeline (Haemaccel) was examined for its anaphylactoid and allergoid reactions in a controlled clinical trial on a homogenous sample of orthopaedic patients. In two test groups histamine H1- and H2-receptor antagonists were applied, in the control group saline as a placebo premedication. Unexpectedly no anaphylactoid reaction associated with histamine release greater than or equal to 1 ng/ml plasma occurred in the trial. Clinically unimportant allergoid reactions restricted to the skin occurred with a lower frequency (18%) than observed in previous trials. The specific premedication was highly effective in preventing these reactions in the two test groups (p less than 0.0005). Due to the apparent improvement of the product a general premedication with histamine H1- and H2-receptor antagonist seems not to be necessary before polygeline is administered to patients. For reasons of safety, however, it seems to be indicated in patients at risk, such as those with carcinoma, a proven allergic diathesis and in those who have already suffered from an incident to plasma substitutes.

Anaphylaxis↗